OXYCONTIN 5 MG

Israel - English - Ministry of Health

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Active ingredient:
OXYCODONE HYDROCHLORIDE
Available from:
RAFA LABORATORIES LTD
ATC code:
N02AA05
Pharmaceutical form:
TABLETS CONTROLLED RELEASE
Composition:
OXYCODONE HYDROCHLORIDE 5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
NAPP PHARMACEUTICALS LTD, UK
Therapeutic group:
OXYCODONE
Therapeutic area:
OXYCODONE
Therapeutic indications:
For the relief of moderate to severe chronic pain.
Authorization number:
131 75 30830 11
Authorization date:
2014-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

21-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

05-03-2019

Patient Leaflet According to the Pharmacists' Regulations

)Preparations( - 1986

This medicine is sold with a doctor's prescription only

OxyContin 5

Controlled Release Tablets

Active ingredient:

Each tablet contains: Oxycodone hydrochloride 5 mg

For a list of inactive ingredients, please see section 6.

Also see 'Important information about some of the medicine's ingredients'

in section 2.

Read this entire leaflet carefully before using this medicine.

This leaflet contains concise information about the medicine. If you have any

further questions, please refer to your doctor or pharmacist.

This medicine has been prescribed for the treatment of your illness. Do not

pass it on to others. It may harm them, even if it seems to you that their illness

is similar to yours.

Medicines of the opioids group may cause addiction, especially with prolonged

use and they have a potential for misuse and overdose. A reaction to an

overdose, may be manifested by slow breathing and may even cause death.

Make sure you know the name of the medicine, the dosage that you take, how

often you take it, the duration of treatment, potential side effects and risks.

Additional information regarding the risk of dependence and addiction can

be found at the following link:

https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf

Taking this medicine along with medicines from the benzodiazepines group,

other medicines which depress the central nervous system )including drugs(

or alcohol may cause a feeling of profound drowsiness, breathing difficulties

)respiratory depression(, coma and death.

1. What is the medicine intended for?

This medicine is intended for the relief of moderate or severe continuous pain.

Therapeutic group: Opioid analgesics

2. Before you take the medicine

Do not use this medicine if:

Do not use if you are sensitive )allergic( to the active ingredient, to other

opioids or to any of the other ingredients of this medicine )for a list of

inactive ingredients, please see section 6(.

Do not use if you suffer from respiratory depression, severe bronchial

asthma, hypercarbia )excess carbon dioxide in the blood( or from severe

lung function impairments, such as COPD.

Do not use if you suffer from a failure of the right side of the heart )a

condition known as cor pulmonale, manifested by pulmonary hypertension

and enlargement of the right ventricle(.

Do not use if you suffer from severe kidney impairment or from moderate

to severe liver impairment.

Do not use if you suffer from intestinal obstruction, suspected intestinal

obstruction, severe abdominal pain, delayed gastric emptying, chronic

constipation.

Do not use if you suffer from a head injury, or if you are about to undergo

surgery or if you have undergone surgery in the past 24 hours.

Do not use this medicine if you are currently taking a medicine of the

monoamine oxidase inhibitors )MAOIs( group or if you have taken this

type of medicine within the last two weeks.

Do not use this medicine if you are pregnant or breastfeeding.

Special warnings regarding the use of this medicine:

Do not chew, crush, dissolve, halve or break the tablet.

Do not use this medicine if you cannot swallow the tablet whole.

OxyContin tablets contain oxycodone, an opioid substance, and have potential

for abuse. Do not give OxyContin to another person. Take all precautions to

prevent this medicine from reaching anybody other than the patient.

Long-term use may lead to dependence!

Do not stop taking this medicine abruptly without consulting your doctor. When

discontinuing the treatment, the dosage should be reduced gradually in order

to prevent withdrawal symptoms, such as: agitation, anxiety, palpitations,

changes in heart rate, blood pressure and/or respiration, shaking, chills,

sweating, excessive secretion )lacrimation, rhinorrhea(, muscle and joint

pains, eye pupil dilation, back pains, abdominal cramps, weakness, insomnia,

nausea, vomiting, loss of appetite, diarrhea.

Inform your doctor about taking this medicine before any action involving

anaesthesia, surgery )including dental( or an urgent treatment.

Avoid sudden position changes from lying/sitting to standing, in order to

prevent dizziness and in extreme cases fainting.

Extra care is required in the elderly, because of their increased sensitivity to

the medicine.

If you are sensitive to any type of food or medicine, inform your doctor before

starting treatment with this medicine.

Before the treatment with OxyContin tell your doctor:

If you suffer or have suffered in the past from impaired function of the:

respiratory system )such as asthma of any type(, heart and/or the blood

vessels )especially low blood pressure(, liver, gallbladder, adrenal gland,

kidneys/urinary system, prostate gland.

If you suffer or have suffered in the past from problems of the digestive system,

e.g. intestinal surgery, constipation or inflammatory bowel disease )IBD(.

If you suffer or have suffered in the past from convulsions, inflammation of

the pancreas, underactive thyroid gland, raised intracranial pressure )can

be manifested by severe headaches, among other things(, mental problems

due to influence of toxic substances )toxic psychosis(, addiction to alcohol,

medicines or drugs.

If you have suffered in the past from withdrawal symptoms )upon stopping

use of medicines or drugs(, such as: agitation, anxiety, shaking or sweating.

If you are taking or have recently taken any other medicines, including

non-prescription drugs and nutrition supplements, please tell your doctor

or pharmacist. Especially inform your doctor or pharmacist if you are taking

the following medicines )it should be noted that the following list mentions

the active ingredients of the medicines. If you are unsure whether you are

using one of these medicines, please consult with your doctor or pharmacist(:

Medicines that affect the central nervous system )e.g. sedatives and hypnotics –

including benzodiazepines, antianxiety medicines, medicines for the treatment

of mental disorders such as phenothiazines or neuroleptic medicines(.

Antidepressants.

Medicines to treat high blood pressure, muscle relaxants, diuretics, medicines

with an anticholinergic activity )used for example for the treatment of

Parkinson's disease(.

Antifungal medications )e.g. ketoconazole, voriconazole(.

Medicines against the HIV virus )e.g. ritonavir(.

Quinidine )for the treatment of heart problems(, cimetidine )a medicine for

the treatment of digestive problems such as stomach ulcer, heartburn(.

Carbamazepine, phenytoin )for the treatment of epilepsy(.

Antibiotics of the macrolide group )e.g. erythromycin, clarithromycin(,

rifampicin )rifampin(.

Anaesthetics

Naltrexone and other opioid analgesics.

Medicines of the monoamine oxidase inhibitors )MAOIs( group – please see

section 'Do not use the medicine if'.

Use of this medicine and food:

This medicine can be taken regardless

of meal times.

Use of this medicine and alcohol consumption:

Do not drink alcohol during treatment with this medicine.

Drinking alcohol while using this medicine may make you feel more sleepy or

increase the risk of severe side effects, such as breathing difficulties with risk

of stopping breathing and loss of consciousness.

Pregnancy and breastfeeding:

Do not use this medicine if you are pregnant or breastfeeding.

Driving and use of machinery:

The use of this medicine may affect alertness, and therefore requires caution

while driving a car, operating dangerous machinery, or when engaging in any

other activity requiring alertness. As for children, they should be warned against

riding a bicycle or playing near roads, etc.

Use in Children:

This medicine is not intended for children under the age of 6 years.

Consult the doctor regarding the use in children and adolescents between

6-18 years of age.

Do not use OxyContin 10, 20, 40 and 80 in children and adolescents under

the age of 18 years.

Important information about some of the medicine's ingredients:

This medicine contains lactose. If you are sensitive to lactose, inform your

doctor before taking this medicine )see section 6(.

3. How to use this medicine?

Always use according to the doctor's instructions. Check with your doctor or

pharmacist if you are not sure. The dosage and the manner of treatment will

be determined by the doctor only.

The standard dosage is usually:

The doctor will adjust the dosage according to your condition and the intensity

of your pain. The medicine should be administered at set intervals )usually

every 12 hours(, as determined by the attending doctor.

Do not use this medicine more often.

Do not exceed the recommended dose.

Do not change the dosage without consulting the attending doctor. If during

treatment with the medicine, you continue to feel pain – refer to your doctor. Also

report to the doctor if you experience events of breakthrough pain.

Do not chew, crush, dissolve, halve or break the tablet! Swallow with a glass

of water, the whole tablet, otherwise the absorption may be faster which will

cause severe side effects such as an overdose )please see section 'If you have

accidentally taken a higher dosage'(.

Do not retain the tablet in your mouth beyond the time necessary to swallow it.

The active ingredient is gradually released from the tablet during its presence

within the body and the empty tablet shell may come out in your stool )or in a

bag, after a colon surgery(. This is not worrisome, since the active ingredient

has already been absorbed into the body.

Tests and follow up:

During long-term treatment, you must undergo periodic

evaluations, to evaluate the ongoing need for the medicine.

If you have accidentally taken a higher dosage

or if a child or anyone else

has accidentally swallowed the medicine, proceed immediately to a doctor or a

hospital emergency room and bring the package of the medicine. The symptoms

of an overdose may include: nausea/vomiting, dizziness, constriction of the

eye pupil, decrease in blood pressure, hallucinations, extreme drowsiness.

Additionally, in severe cases, breathing difficulties that can cause loss of

consciousness may occur. These symptoms require urgent medical assistance.

If you forget to take this medicine:

If you remember within 4 hours of the time you were supposed to take the

medicine, take it immediately. Take the next dose at the regular time. If it

has been more than 4 hours since you were supposed to take the medicine,

consult a doctor.

Do not take a double dose to compensate for the forgotten dose!

Continue with the treatment as recommended by your doctor.

Even if your state of health improves, do not stop taking this medicine without

consulting your doctor or pharmacist, and even then only gradually.

If you stop taking this medicine:

Do not stop taking this medicine abruptly,

unless instructed by the doctor. If you want to stop taking this medicine, consult

your doctor who will guide you how to do it, so you do not experience withdrawal

symptoms, such as: agitation, anxiety, palpitations, changes in heart rate, blood

pressure and/or respiration, shaking, chills, sweating, excessive secretion

)lacrimation, rhinorrhea(, muscle and joint pains, eye pupil dilation, back pains,

abdominal cramps, weakness, insomnia, nausea, vomiting, loss of appetite,

diarrhea.

Do not take medicines in the dark! Check the label and the dose each time you

take a medicine. Wear glasses if you need them.

If you have any further questions regarding the use of this medicine, consult

your doctor or pharmacist.

4. Side effects

Like any medicine, the use of OxyContin may cause side effects in some users.

If these side effects persist or if they are bothersome or get worse, consult your

doctor. Do not be alarmed while reading the list of side effects, you may not

suffer from any of them.

Refer to a doctor or a hospital emergency room immediately if the following

side effects occur:

Allergic or anaphylactic reaction )manifested by breathing difficulties, swelling of

the face and throat area, rash and itching upon extended areas(, convulsions,

respiratory depression, slow and weak breathing, confusion, memory

disturbances, heavy drowsiness, movement disturbances, strong abdominal

pains, intestinal obstruction, decrease in blood pressure, loss of consciousness,

rapid heart rate, decreased urination or urinating difficulty, dehydration, excessive

sweating or chills, constricted eye pupils, hallucinations, thought disturbances.

Common side effects )appear in more than 1 out of 100 patients(: constipation

)the doctor can prescribe you a laxative medicine(, dry mouth, digestion

problems, abdominal pains or discomfort, diarrhea, nausea, vomiting, loss

of appetite, anorexia, drowsiness, nervousness, depression, anxiety, tremor,

headache, breathing difficulties, shortness of breath, wheezing, decreased

cough reflex, dizziness, abnormal fatigue or weakness, sleeping difficulties,

confusion, sweating, abnormal thoughts and dreams, itching and/or other

hypersensitivity manifestations such as rash or irritation.

Uncommon side effects )appear in less than 1 out of 100 patients(: mood

changes, feeling faint, chills, convulsions, changes in taste, agitation,

hypersensitivity to pain, chest pains, decrease in blood pressure, hallucinations,

fast or irregular heartbeat, dehydration, feeling of extreme happiness, decreased

sexual drive, impotence, absence of menstrual periods in women, redness of

the skin, flushing, thirst, edemas, enlarged lymph nodes, swelling of the hands,

ankles or feet, vision disturbances, ringing in the ears, vertigo, restlessness,

disorientation, reduced sensitivity to pain or touch, tingling or numbness, fever,

speech difficulties, memory disturbances, spasms and changes in muscle

tension, flatulence, difficulty in swallowing, hiccups, problems in the digestive

system e.g. upset stomach, biliary tract disturbances )may be manifested by itchy

skin, yellowing of the skin, dark urine, pale stools(, inflammation of the stomach,

difficulty in passing urine, retention of urine, tooth decay, reduction in size of the

eye pupils, increase in liver enzymes, decrease in sodium levels, changes in ECG

test )ST section(, dry skin, severe peeling of the skin, urticaria, development of

tolerance and dependence to the medicine, generally feeling unwell.

Side effects and drug interactions in children:

Parents should inform the attending doctor regarding any side effect and any

additional medicine given to the child. See above for details of side effects and

interactions with other medicines.

In any case you experience side effects that are not mentioned in this leaflet,

or if you feel a change in your general feeling, consult your doctor immediately!

5. How to store the medicine

Avoid poisoning! This medicine, and any other medicine, must be stored in a

safe place out of the reach of children and/or infants, to avoid poisoning. Do not

induce vomiting unless explicitly instructed to do so by a doctor.

When you no longer need the tablets, consult with the pharmacist about the

manner of their disposal.

Do not use the medicine after the expiry date )exp. date( stated on the

package. The expiry date refers to the last day of that month.

Storage conditions: store below 25°C.

6. Additional information

In addition to the active ingredient, the tablets also contain the following

inactive ingredients:

Lactose, stearyl alcohol, ammonio methacrylate copolymer, povidone,

hypromellose, talc, glyceryl triacetate, magnesium stearate, titanium dioxide,

macrogol 400, brilliant blue )E133(.

The tablet contains approximately 77 mg of lactose.

What does the medicine look like and what does the package contain?

Light blue colored tablets, 20 tablets per box, in blisters.

Manufacturer:

Napp Pharmaceuticals, UK.

Registration holder:

Rafa Laboratories Ltd., P.O.Box 405, Jerusalem

9100301

Medicine registration number in the National Medicine Registry of

the Ministry of Health:

1317530830

This leaflet was checked and approved by the Ministry of Health in October 2013.

194276

276005-N

:ءاودلا تابكرم نم ءزج نع ةمهم تامولعم .)٦ دنبلا رظنا( ءاودلا اذه لوانت لبق بيبطلا ملاعإ بجيف ,زوتكلال ا

ساسح تنك اذإ .زوتكلا ىلع يوتحي ءاودلا ؟ءاودلا لمعتست فيك .۳ ديدحت متيس .ا

دكأتم نكت مل اذإ

يلديصلا وأ بيبطلا ةعجارم كيلع .بيبطلا تاميلعتل ا

قفو لامعتسلاا ا

مود بجي .طقف بيبطلا لب

ق نم جلاعلا ةقيرطو ةعرجلا

:

ّ

يه ماع لكشب ةيدايتعلاا ةعرجلا ةداع( ةمظتنم تاقوأ يف ءاودلا لوانت بجي .كملأ ةدشلو كعضول ا

قفو ةعرجلا بيبطلا كل طبضي فوس

براقت رثكأ تاقوأ يف ءاودلا اذه لامعتسا زوجي لا .جلاعملا بيبطلا هد

دح

ي ام بجومب ,)ةعاس ۱۲ لك .اهب ىصوملا ةعرجلا زواجت زوجي لا ،ءاودلاب جلاعلا للاخ مللأاب روعشلا كيدل

رمتسا اذإ .جلاعملا بيبطلا ةراشتسا نود ةعرجلا رييغت زوجي لا .يئاجفلا مللأا نم ا

ثادحأ ربتخت تنك اذإ جلاعملا بيبطلا غلابإ بجي كلذك .بيبطلا ىلإ هجوتف دق

لاإو ءاملا نم سأك عم هلمكأب صرقلا علب بجي !صرقلا رسك وأ رطش ,ةباذإ ,قحس ,غضم زوجي لا تطرفأ اذإ' دنبلا رظنا( ةطرفملا ةعرجلا لثم ,ةميخو ةيبناج ا

ضارعأ ببسي دقو عرسأ صاصتملاا نوكي .)'ةعرجلا لوانت يف أطخلاب .هعلبل بولطملا تقولا نم رثكأ مفلا يف صرقلا ءاقبإ زوجي لا زاربلا يف صرقلل غرافلا بلاقلا جرخي دقو مسجلا يف هثوكم للاخ ا

يجيردت صرقلا نم ةلاعفلا ةداملا ررحتت ةداملا نلأ كلذو ,قلقلا ريثت لا ةرهاظلا هذه .)ظيلغلا يعملا ةحارج دعب ,سيكلا يف وأ( .مسجلا يف تصتما دق ةلاعفلا ةجاحلا مييقتل كلذو ,ةيرود تامييقت ءارجإ كيلع ,دملأا ليوطلا جلاعلا للاخ :ةعباتملاو تاصوحفلا .ءاودلل ةرمتسملا ,أطخلا قيرط نع ءاودلا نم رخآ صخش يأ وأ لفط علب اذإ وأ ةعرجلا لوانت يف أطخلاب تطرفأ اذإ .ءاودلا ةوبع كعم ا

بحطصم ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ ا

روف هجوتلا كيلع بجيف ,ةسوله ,مدلا طغض ضافخنا ,نيعلا ةقدح ق

يضت ,راو

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.ةلجعتسم ة

يبط ةدعاسم مزلتست :ءاودلا لوانت تيسن اذإ ةعرجلا لوانت .ا

روف هلوانتف ,ءاودلا لوانتت نأ هيف يغبني ناك يذلا تقولا نم تاعاس ٤ للاخ تركذت اذإ .يدايتعلاا تقولا يف ةيلاتلا لا .بيبطلا ةراشتسا بجيف ,ءاودلا لوانتت نأ هيف يغبني ناك يذلا تقولا ىلع تاعاس ٤ نم رثكأ ت

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يلديصلا وأ بيبطلا ةراشتسا نود جلاعلا فاقيإ زوجي لا .طقف يجيردت لكشب ةلاحلا هذه يف جلاعلا فاقيإ ا

ضيأ اذإ .كلذب بيبطلا رمآ اذإ

لاإ ,

يئاج

ف لكشب ءاودلا لوانت نع فقوتلا زوجي لا :ءاودلا لوانت نع تفقوت اذإ ضارعأ ربتخت نأ نود اذهب موقت فيك كدشر

ي يك بيبطلا ةراشتسا بجيف ,ءاودلا لوانت نع فقوتلا ديرت تنك ,فاجترا ,سفنتلا وأ/و مدلا طغض ,بلقلا مظن يف تارييغت ,ديدش بلق ناقفخ ,ق

ق ,ل

مل

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وت ,لصافملاو تلاضعلا يف ملاآ ,)فنلأا نلايس ,ناعم

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ظنلا

يلديصلا وأ بيبطلا ةراشتساب م

قف ,ءاودلا لامعتسا لوح ةيفاضإ ةلئسأ كيدل تناك اذإ ةيبناجلا ضارعلأا .٤ شلاتت مل اذإ .نيمدختسملا نم ءزج ىدل ةيبناج ا

ضارعأ نيتنوكيسكو

أ لامعتسا ببسي دق ,ءاود

يأ لثم ضارعلأا ةمئاق ةءارق دنع عزفت لا .بيبطلا ةراشتسا بجيف ,مقافتت وأ كجعزت اهنأ وأ ةيبناجلا ضارعلأا .اهنم يأب باصت لاأ نكمملا نم هنلأ ,ة

يبناجلا

يلاتلا ةيبناجلا ضارعلأا ترهظ اذإ ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ ا

ً

روف هجوتلا بجي ةكحو يدلج حفط ,قلحلاو هجولا ةقطنم يف مروت ,سفنت تابوعصب ىلجتي(

يقأت وأ )

يسسحت(

يج

أ لعف

در ساع

ن ,ةركاذلا يف تابارطضا ,كابترا ,فيعضو ءيطب سفنت ,

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قت ,ةريرعشق وأ ق

رعتلا طرف ,فافج ,لوبتلا ةبوعص وأ ل

وبتلا ةلق ,ب

قلا مظن ع

ُّ

.ريكفتلا يف تابارطضا :)جلاعم ۱00 نيب نم ۱ نم رثكأ ىدل رهظت( ةبراقتم تاقوأ يف رهظت يتلا ةيبناجلا ضارعلأا ةحار مدع وأ نطبلا يف ملاآ ,مضهلا يف لكاشم ,مفلا يف فافج ,)ا

يل

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ص ,فاجترا ,قلق ,بائتكا ,ةيبصع ,ساع

ن ,م

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يدايتعا ريغ بعت ,راو

د ,لاعسلا سكعنم فعض ,زيزأ ,سفنت قيض ,سفنتلا يف

يهتلا وأ يدلجلا حفطلا لثم سسحتلا طرف ضارعأ وأ/و ةكح ,ةيدايتعا ريغ ملاحأو راكفأ ,ق

عت ,كابترا :)جلاعم ۱00 نيب نم ۱ نم لقأ ىدل رهظت( ةدعابتم تاقوأ يف رهظت يتلا ةيبناجلا ضارعلأا ,مللأل ةيساسحلا طرف ,ل

مل

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يسنج زجع( ة

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ع ,ةيسنجلا ةوهشلا ضافخنا ,اهب ,ةيؤرلا تابارطضا ,نيمدقلا وأ نيلحاكلا ,نيديلا مروت ,ةيوافميللا دد

غلا مخضت ,تامذو ,شطع ,هجولا رارمحا ,ةنوخس ,ليمنت وأ زخو ,سمللا وأ مللأاب ساسحلإا ضافخنا ,ناهوت ,ءوده مدع ,ةخود ,نينذلأا يف نينط يف ةبوعص ,تازاغ ,تلاضعلا رتوت يف تاريغتو تاجنشت ,ةركاذلا يف تابارطضا ,ملاكلا يف تابارطضا يتلا( ةيوارفصلا كلاسملا يف تابارطضا ,مضهلا رسع لثم يمضهلا زاهجلا يف لكاشم ,ةقوزاح ,علبلا ,ةدعملا يف باهتلا ,)نوللا تهاب زار

ب ,نكاد لوب ,ةرشبلا رارفصا ,دلجلا يف ةكح لكش ىلع ىلجتت نأ اهنكمي ضافخنا ,دبكلا تاميزنإ ىوتسم عافترا ,نيعلا ةقدح صلقت ,نانسلأا سوست ,لوبلا سابتحا ,لوبتلا يف ةبوعص ,دلجلل داح رشقت ,دلجلا فافج ,)ST عطقم( ب

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م صحف يف تاريغت ,مويدوصلا تايوتسم .ءوسلاب ماع روعش ,ءاودلاب قلعتو لمحت رو

طت ,ى

رش :لافطلأا ىدل ةيئاود تلاعافتو ةيبناج ضارعأ هلاعأ رظنا .لفطلل ىطع

ي يفاضإ ءاود لك نعو يبناج ضرع لك نع جلاعملا بيبطلا غلابإ نيدلاولا ىلع .ليصفتلاب اهفصو مت يتلا ةيئاودلا تلاعافتلاو ةيبناجلا ضارعلأا ماعلا كروعش ىلع رييغت يأ أرط اذإ وأ ,ةرشنلا هذه يف ركذت مل ةيبناج ضارعأب اهيف رعشت ةلاح لك يف

روف بيبطلا ةراشتسا كيلع بجيف ؟ءاودلا نزخت فيك .٥ عضرلا وأ/و لافطلأا يديأ لوانتم نع ا

ديعب قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت .بيبطلا نم ةحيرص تاميلعت نود ؤيقتلا ببست لا .ممستلا عنمتس كلذبو .اهنم صلختلا لوح

يلديصلا ةراشتساب م

ق ,صارقلأا ىلإ ةجاحب دعت مل امدنع ريشيو .ةوبعلا ىلع رهظي يذلا ,)exp. date( ةيحلاصلا ءاهتنا خيرات دعب ءاودلا لامعتسا زوجي لا

.رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ءاهتنا خيرات .ةيوئم ةجرد ۲٥ نود ةرارح ةجرد يف نيزختلا بجي :نيزختلا فورظ ةيفاضإ تامولعم .٦ :ةيلاتلا ةلاعفلا ريغ داوملا ىلع ا

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ضيأ صارقلأا يوتحت ,ةلا

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عفلا ةداملا ىلإ ةفاضإ

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hypromellose, talc, glyceryl triacetate, magnesium stearate, titanium dioxide,

macrogol 400, brilliant blue )E133(.

.زوتكلا غلم ۷۷ براقي ام ىلع صرقلا يوتحي ؟ةوبعلا ىوتحم وه امو ءاودلا ودبي فيك

صرق ۲0 نم تاحيول ةوبع يف ,يوامسلا قرزلأا نوللاب صارقأ .ارتلجنإ ,لاكيتويسمراف ݒان :ةجتنملا ةهجلا ۹۱00۳0۱ سدقلا ميلشروأ , ٤0٥ .ب.ص ,.ض.م افر تاربتخم :ليجستلا بحاص ۱۳۱۷٥۳0۸۳0 :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا ليجست مقر .۲0۱۳ لولأا نيرشت/ربوتكأ يف ةحصلا ةرازو لبق نم اهيلع ةقداصملا

متو ةرشنلا هذه تصح

.نيسنجلا لاكل صصخ

م ءاودلا نكل ,ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ,ةءارقلا ليهستو طيسبتلل

OxyContin-DL-Feb2013_Jan2019-04_Box

Doctor Leaflet

1.

NAME OF THE MEDICINAL PRODUCT

OxyContin

10, 20, 40, 80 Controlled Release Tablets (New Formulation)

OxyContin

5 Controlled Release Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

OxyContin 5 contains 5 mg of oxycodone hydrochloride.

OxyContin 10 contains 10 mg of oxycodone hydrochloride.

OxyContin 20 contains 20 mg of oxycodone hydrochloride.

OxyContin 40 contains 40 mg of oxycodone hydrochloride.

OxyContin 80 contains 80 mg of oxycodone hydrochloride.

For excipients see section 6.1.

3.

PHARMACEUTICAL FORM

Controlled release tablets.

The 5 mg tablets are light blue.

The 10 mg tablets are white.

The 20 mg tablets are pink.

The 40 mg tablets are yellow.

The 80 mg tablets are green.

4.

CLINICAL PARTICULARS

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS

DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS)

depressants, including alcohol, may result in profound sedation, respiratory depression, coma,

and death [see 'Drug Interactions'].

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment

options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

4.1

Therapeutic indications

For the relief of moderate to severe chronic pain.

4.2

Posology and method of administration

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed.

OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure

complete swallowing immediately after placing in the mouth.

Elderly and adults over 18 years:

OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of

the pain, and the patient’s previous history of analgesic requirements.

OxyContin is not intended for use as a prn analgesic.

Increasing severity of pain will require an increased dosage of OxyContin tablets using the 5 mg, 10

mg, 20 mg, 40 mg or 80 mg tablet strengths, either alone or in combination, to achieve pain relief. The

correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12

hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent

this. If higher doses are necessary increases should be made, where possible, in 25% - 50%

increments. The need for escape medication more than twice a day indicates that the dosage of

OxyContin tablets should be increased.

The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled

by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to

minimise the incidence of side effects. The dose should then be carefully titrated, as frequently as once

a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12-

hourly. However, a few patients may require higher doses. Doses in excess of 1000 mg have been

recorded.

Patients receiving oral morphine before OxyContin therapy should have their daily dose based on the

following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be

emphasised that this is a guide to the dose of OxyContin tablets required. Inter-patient variability

requires that each patient is carefully titrated to the appropriate dose.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that,

compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward

adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are

appropriate.

Pediatric use

OxyContin 10, 20, 40, 80: should not be used in patients under 18 years of age.

OxyContin 5: Safety and effectiveness of OxyContin in pediatric patients below the age of 18 years

have not been established.

Adults with mild to moderate renal impairment and mild hepatic impairment:

The plasma concentration in this population may be increased. Therefore dose initiation should

follow a conservative approach. Patients should be started on OxyContin 5 mg 12-hourly or

oxycodone HCl liquid 2.5 mg 6-hourly and titrated to pain relief as described above.

Use in non-malignant pain:

Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the

only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids

include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment

in non-malignant pain should be assessed at regular intervals.

Cessation of therapy:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose

gradually to prevent symptoms of withdrawal.

4.3

Contraindications

Hypersensitivity to any of the constituents, respiratory depression, head injury, known or suspected

paralytic ileus and GI obstruction, acute abdomen, delayed gastric emptying, chronic obstructive

airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known oxycodone sensitivity or

in any situation where opioids are contra-indicated, moderate to severe hepatic impairment, severe

renal impairment (creatinine clearance

10 ml/min), chronic constipation, concurrent administration of

monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for

pre-operative use or for the first 24 hours post-operatively. Patients with rare hereditary problems of

galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not

take the 5 mg strength. Pregnancy.

4.4

Special warnings and precautions for use

The major risk of opioid excess is respiratory depression.

Closely monitor patients for respiratory

depression when initiating therapy with OxyContin and following dose increases.

Instruct patients on proper administration of OxyContin tablets to reduce the risk

As with all narcotics, a reduction in dosage may be advisable in hypothyroidism.

Use with caution in patients with raised intracranial pressure, hypotension, hypovolaemia, toxic

psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic

hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic

disease or severe pulmonary disease, and debilitated, elderly patients.

The oxycodone in OxyContin may aggravate convulsions in patients with convulsive disorders, and

may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure

disorders for worsened seizure control during OxyContin therapy.

OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. Should

paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued

immediately. As with all opioid preparations, patients about to undergo additional pain relieving

procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to

the intervention. If further treatment with OxyContin tablets is indicated then the dosage should be

adjusted to the new post-operative requirement.

OxyContin 80 mg should not be used in patients not previously exposed to opioids. This tablet

strength may cause fatal respiratory depression when administered to opioid naïve patients.

As with all opioid preparations, OxyContin tablets should be used with caution following abdominal

surgery as opioids are known to impair intestinal motility and should not be used until the physician is

assured of normal bowel function.

For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of

a comprehensive treatment programme involving other medications and treatment modalities. A crucial

part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and

substance abuse history. There is potential for development of psychological dependence

(addiction) to opioid analgesics, including oxycodone. OxyContin tablets, like all opioids, should be

avoided in patients with a history of, or present alcohol and drug abuse.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to

minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a

minimum of side effects. There must be frequent contact between physician and patient so that dosage

adjustments can be made. It is strongly recommended that the physician defines treatment outcomes

in accordance with pain management guidelines. The physician and patient can then agree to

discontinue treatment if these objectives are not met.

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur in

particular in high doses. An oxycodone dose reduction or change in opioid may be required.

OxyContin has an abuse profile similar to other strong opioids. Oxycodone may be sought and

abused by people with latent or manifest addiction disorders.

As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms

and may have respiratory depression at birth.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. The administration

of broken, chewed or crushed OxyContin tablets leads to a rapid release and absorption of a

potentially fatal dose of oxycodone (see Section 4.9).

OxyContin 10, 20, 40, 80: There have been post-marketing reports of difficulty in swallowing

OxyContin tablets. These reports included choking, gagging, regurgitation and tablets stuck in the

throat. Instruct patients not to pre-soak, lick or otherwise wet OxyContin tablets prior to placing in the

mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately

after placing in the mouth. There have been rare post-marketing reports of cases of intestinal

obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to

remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer

with a small gastrointestinal lumen are at greater risk of developing these complications. Use caution

when prescribing OxyContin for patients who have difficulty swallowing or have underlying GI

disorders that may predispose them to obstruction. Consider use of an alternative analgesic in

patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a

small gastrointestinal lumen.

Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin;

concomitant use should be avoided.

Abuse of the tablets by parenteral administration can be expected to result in other serious adverse

events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis,

and valvular heart injury, which may be fatal.

4.5

Interaction with other medicinal products and other forms of interaction

OxyContin, like other opioids, potentiates the effects of tranquillisers, anaesthetics, hypnotics, anti-

depressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and

antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics,

producing CNS excitation or depression with hypertensive or hypotensive crisis.

Concurrent use of OxyContin and other central nervous system (CNS) depressants including

sedatives or hypnotics

such as benzodiazepines

, general anesthetics, phenothiazines, tranquilizers,

and alcohol can increase the risk of respiratory depression, hypotension, profound sedation or coma.

Monitor patients receiving CNS depressants and OxyContin for signs of respiratory depression and

hypotension. When such combined therapy is contemplated, reduce the initial dose of OxyContin and

consider using a lower dose of the concomitant CNS depressant.

Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be

avoided.

Mixed Agonist/Antagonist Opioid Analgesics (i.e., pentazocine, nalbuphine, and butorphanol) - should

generally not be administered to a patient who has received or is receiving a course of therapy with a

pure opioid agonist analgesic such as OxyContin. In this situation, mixed agonist/antagonist

analgesics may reduce the analgesic effect of oxycodone and may precipitate withdrawal symptoms in

these patients.

Diuretics - opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic

hormone. opioids may also lead to acute retention of urine by causing spasm of the sphincter of the

bladder, particularly in men with enlarged prostates.

Anticholinergics or other medications with anticholinergic activity - when used concurrently with

opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which

may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility

when OxyContin is used concurrently with anticholinergic drugs.

Oxycodone is metabolized in part via the CYP2D6 and CYP3A4 pathways. The activities of these

metabolic pathways may be inhibited or induced by various co-administered drugs or dietary

elements. Oxycodone doses may need to be adjusted accordingly.

Cimetidine and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., clarithromycin, erythromycin),

azole-antifungal agents (e.g., ketoconazole, voriconazole), and protease inhibitors (e.g., ritonavir),

may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma

concentrations.

CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of

oxycodone and cause increased clearance of the drug, resulting in a decrease in oxycodone plasma

concentrations.

Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased

clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.

4.6

Pregnancy and lactation

OxyContin tablets are not recommended for use in pregnancy nor during labour. Infants born to

mothers who have received opioids during pregnancy should be monitored for respiratory depression.

Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn.

OxyContin tablets should, therefore, not be used in breast-feeding mothers.

4.7

Effects on ability to drive and use machines

Oxycodone may modify patients’ reactions to a varying extent depending on the dosage and individual

susceptibility. Therefore patients should not drive or operate machinery if affected.

4.8

Undesirable effects

Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see

Tolerance and Dependence, below). Constipation may be prevented with an appropriate laxative. If

nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic.

Common (incidence of

1%) and uncommon (incidence of

1%) adverse drug reactions are listed in

the table below.

Body System

Common

Uncommon

Immune system disorders

Anaphylactic reaction

Anaphylactoid reaction

Hypersensitivity

Metabolism and nutritional

disorders

Decreased appetite

Dehydration

Anorexia

Psychiatric disorders

Anxiety

Affect lability

Confusional state

Agitation

Insomnia

Drug dependence

Nervousness

Euphoric mood

Thinking abnormal

Hallucination

Abnormal dreams

Libido decreased

Body System

Common

Uncommon

Depression

Disorientation

Mood altered

Restlessness

Dysphoria

Nervous system disorders

Headache

Amnesia

Dizziness

Hypertonia

Sedation

Hypoaesthesia

Somnolence

Hypotonia

Tremor

Paresthesia

Speech disorder

Convulsions

Muscle contractions involuntary

Dysgeusia

Syncope

Hyperalgesia

Eye disorders

Miosis

Vision impairment

Ear and labyrinth disorders

Vertigo

Tinnitus

Cardiac disorders

Supraventricular tachycardia

Vascular disorders

Hypotension

Orthostatic hypotension

Vasodilatation

Facial flushing

Respiratory, thoracic and

mediastinal disorders

Bronchospasm

Dyspnoea

Respiratory depression

Hiccups

Cough decreased

Gastrointestinal disorders

Constipation

Nausea

Vomiting

Dry mouth

Dyspepsia

Abdominal Pain

Diarrhoea

Dental caries

Dysphagia

Eructation

Flatulence

Ileus

Gastritis

Hepato-biliary disorders

Biliary colic

Cholestasis

Hepatic enzyme increased

Skin and subcutaneous tissue

disorders

Hyperhidrosis

Pruritus

Rash

Dry skin

Exfoliative dermatitis

Musculoskeletal and

connective tissue disorders

Muscular rigidity

Renal and urinary disorders

Urinary retention

Ureteral spasm

Reproductive system and

breast disorders

Amenorrhoea

Erectile dysfunction

Body System

Common

Uncommon

General disorders and

administration site conditions

Asthenic conditions

Drug tolerance

Oedema

Oedema peripheral

Malaise

Thirst

Pyrexia

Drug withdrawal syndrome

Chills

Lymphadenopathy

Chest pain

ST depression ( investigations)

OxyContin 10, 20, 40, 80: The following have also been reported, potentially due to the swelling and

hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and

difficulty swallowing the tablet.

Tolerance and Dependence:

The patient may develop tolerance to the drug with chronic use and require progressively higher

doses to maintain pain control. Prolonged use of OxyContin tablets may lead to physical

dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a

patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to

prevent symptoms of withdrawal. The opioid abstinence or withdrawal syndrome is characterised by

some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills,

myalgia, mydriasis and palpitations. Other symptoms also may develop, including: irritability,

anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting,

diarrhoea, or increased blood pressure, respiratory rate or heart rate.

Postmarketing Experience:

The following adverse reactions have been identified during post-approval use of controlled-release

oxycodone: abuse, addiction, amenorrhea, cholestasis, death, dental caries, increased hepatic

enzymes, hyperalgesia, hyponatremia, ileus, muscular hypertonia, overdose, palpitations (in the

context of withdrawal), seizures, syndrome of inappropriate antidiuretic hormone secretion, and

urticaria.

Anaphylaxis has been reported with ingredients contained in OxyContin. Advise patients how to

recognize such a reaction and when to seek medical attention.

4.9

Overdose

Signs of oxycodone toxicity and overdose are miosis, respiratory depression, hypotension and

hallucinations. Circulatory failure and somnolence progressing to stupor or deepening coma,

hypotonia, bradycardia, and death may occur in more severe cases.

The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or other

psychotropic drugs.

Treatment of oxycodone overdosage: Primary attention should be given to the establishment of a

patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and

0.01 mg/kg body weight for children), if the patient is in a coma or respiratory depression is present.

Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an

infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50

ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical

response). Infusions are not a substitute for frequent review of the patient’s clinical state. Intramuscular

naloxone is an alternative in the event IV access is not possible. As the duration of action of naloxone

is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-

established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously

poisoned patients.

For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1

mg every 2 minutes if required.

The patient should be observed for at least 6 hours after the last dose of naloxone.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory

depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to

persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an

abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

Consider activated charcoal (50 g for adults, 10 -15 g for children), if a substantial amount has

been ingested within 1 hour, provided the airway can be protected. It may be reasonable to

assume that late administration of activated charcoal may be beneficial for prolonged release

preparations; however there is no evidence to support this.

OxyContin tablets will continue to release and add to the oxycodone load for up to 12 hours

after administration and management of oxycodone overdosage should be modified

accordingly. Gastric contents may need to be emptied as this can be useful in removing

unabsorbed drug, particularly when a prolonged release formulation has been taken.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids

ATC code: NO2A AO5

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and

delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The

therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that can

be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.

Clinical symptoms may be manifest from these hormonal changes.

Other pharmacological effects

In- vitro and animal studies indicate various effects of natural opioids, such as morphine, on

components of the immune system; the clinical significance of these findings is unknown. Whether

oxycodone, a semisynthetic opioid, has immunological effects similar to morphine is unknown.

Clinical studies

The efficacy of OxyContin tablets has been demonstrated in cancer pain, post-operative pain and

severe non-malignant pain such as diabetic neuropathy, postherpetic neuralgia, low back pain and

osteoarthritis. In the latter indication, treatment was continued for up to 18 months and proved effective

in many patients for whom NSAIDs alone provided inadequate relief. The efficacy of OxyContin tablets

in neuropathic pain was confirmed by three placebo-controlled studies.

In patients with chronic non-malignant pain, maintenance of analgesia with stable dosing was

demonstrated for up to three years.

5.2

Pharmacokinetic properties

Following absorption, oxycodone is distributed throughout the entire body. Approximately 45% is

bound to plasma protein. Oxycodone is metabolized in the liver via CYP3A4 and CYP2D6 to

noroxycodone, oxymorphone and noroxymorphone, which are subsequently glucuronidated.

Noroxycodone and noroxymorphone are the major circulating metabolites. Noroxycodone is a weak

mu opioid agonist. Noroxymorphone is a potent mu opioid agonist; however, it does not cross the

blood-brain barrier to a significant extent.

Oxymorphone is a potent mu opioid agonist but is present

at very low concentrations following oxycodone administration. None of these metabolites are

thought to contribute significantly to the analgesic effect of oxycodone.

Compared with morphine, which has an absolute bioavailability of approximately 30%, oxycodone has

a high absolute bioavailability of up to 87% following oral administration. Oxycodone has an

elimination half-life of approximately 3 hours and is metabolised principally to noroxycodone and

oxymorphone. Oxymorphone has some analgesic activity but is present in the plasma in low

concentrations and is not considered to contribute to oxycodone’s pharmacological effect.

The release of oxycodone from OxyContin tablets is biphasic with an initial relatively fast release

providing an early onset of analgesia followed by a more controlled release which determines the 12

hour duration of action. The mean apparent elimination half-life of OxyContin is 4.5 hours which leads

to steady-state being achieved in about one day.

Release of oxycodone from OxyContin tablets is independent of pH.

OxyContin tablets have an oral bioavailability comparable with conventional oral oxycodone, but the

former achieve maximal plasma concentrations at about 3 hours rather than about 1 to 1.5 hours.

Peak and trough concentrations of oxycodone from OxyContin tablets 10 mg administered 12-hourly

are equivalent to those achieved from conventional oxycodone 5 mg administered 6-hourly.

OxyContin tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg are bioequivalent in terms of both rate and

extent of absorption. Ingestion of a standard high-fat meal does not alter the peak oxycodone

concentration or the extent of oxycodone absorption from OxyContin tablets.

Elderly

The AUC in elderly subjects is 15% greater when compared with young subjects.

Gender

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on

a body weight adjusted basis. The reason for this difference is unknown.

Patients with renal impairment

Preliminary data from a study of patients with mild to moderate renal dysfunction show peak plasma

oxycodone and noroxycodone concentrations approximately 50% and 20% higher, respectively and

AUC values for oxycodone, noroxycodone and oxymorphone approximately 60%, 60% and 40%

higher than normal subjects, respectively. There was an increase in t

of elimination for oxycodone of

only 1 hour.

Patients with mild to moderate hepatic impairment

Patients with mild to moderate hepatic dysfunction showed peak plasma oxycodone and noroxycodone

concentrations approximately 50% and 20% higher, respectively, than normal subjects. AUC values

were approximately 95% and 75% higher, respectively. Oxymorphone peak plasma concentrations

and AUC values were lower by 15% to 50%. The t

elimination for oxycodone increased by 2.3 hours.

5.3

Preclinical safety data

Teratogenicity

Oxycodone had no effect on fertility or early embryonic development in male and female rats at

doses as high as 8 mg/kg/d. Also, oxycodone did not induce any deformities in rats at doses as high

as 8 mg/kg/d or in rabbits at doses as high as 125 mg/kg/d. Dose-related increases in

developmental variations (increased incidences of extra (27) presacral vertebrae and extra pairs of

ribs) were observed in rabbits when the data for individual fetuses were analyzed. However, when

the same data were analyzed using litters as opposed to individual fetuses, there was no dose-

related increase in developmental variations although the incidence of extra presacral vertebrae

remained significantly higher in the 125 mg/kg/d group compared to the control group. Since this

dose level was associated with severe pharmacotoxic effects in the pregnant animals, the fetal

findings may have been a secondary consequence of severe maternal toxicity.

In a study of peri- and postnatal development in rats, maternal body weight and food intake

parameters were reduced for doses ≥ 2 mg/kg/d compared to the control group. Body weights were

lower in the F1 generation from maternal rats in the 6 mg/kg/d dosing group. There were no effects

on physical, reflexological, or sensory developmental parameters or on behavioural and reproductive

indices in the F1 pups (the NOEL for F1 pups was 2 mg/kg/d based on body weight effects seen at 6

mg/kg/d). There were no effects on the F2 generation at any dose in the study.

Carcinogenicity

Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted

owing to the length of clinical experience with the drug substance.

Mutagenicity

The results of in-vitro and in-vivo studies indicate that the genotoxic risk of oxycodone to humans is

minimal or absent at the systemic oxycodone concentrations that are achieved therapeutically.

Oxycodone was not genotoxic in a bacterial mutagenicity assay or in an in-vivo micronucleus assay

in the mouse. Oxycodone produced a positive response in the in-vitro mouse lymphoma assay in

the presence of rat liver S9 metabolic activation at dose levels greater than 25 μg/mL. Two in-vitro

chromosomal aberrations assays with human lymphocytes were conducted. In the first assay,

oxycodone was negative without metabolic activation but was positive with S9 metabolic activation at

the 24 hour time point but not at other time points or at 48 hour after exposure. In the second assay,

oxycodone did not show any clastogenicity either with or without metabolic activation at any

concentration or time point.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Magnesium stearate

Hypromellose

Titanium dioxide

Macrogol

In addition the tablets contain the following:

OxyContin 5 contains: Brilliant blue (E133), lactose, povidone, talc, ammonio methacrylate co-

polymer, glyceryl triacetate, stearyl alcohol.

OxyContin 10 contains: Hydroxypropylcellulose, polyethylene oxide.

OxyContin 20 contains: Polysorbate 80, red iron oxide (E172), polyethylene oxide.

OxyContin 40 contains: Polysorbate 80, yellow iron oxide (E172), polyethylene oxide.

OxyContin 80 contains: Hydroxypropylcellulose, yellow iron oxide (E172), indigo carmine

(E132), polyethylene oxide.

6.2

Incompatibilities

Not applicable

6.3

Special precautions for storage

Do not store above 25

6.4

Nature and contents of container

PVC blister packs with aluminium foil backing containing 20 tablets.

6.5

Special precautions for disposal and other handling

None.

7.

Marketing authorisation holder and numbers

OxyContin 5 1317530830 (This strength is manufactured by Napp Pharmaceuticals, England).

OxyContin 10 1007128431

OxyContin 20 1007028432

OxyContin 40 1090129255

OxyContin 80 1089829256

Rafa Laboratories Ltd. POB 405, Jerusalem 9100301

The format of this leaflet was determined by the Ministry of Health and its content was checked and

approved in February 2013.

ראורבפ

2019

ה/אפור

,ה/דבכנ ת/חקור

ןודינה

Tablets

Controlled Release

Oxycontin

ולע ןוכדע םינ

ולעהו אפורל ןולעה ונכדוע יכ םכתעידיל איבהל תשקבמ אפר תודבעמ םינ

רישכתה לש ןכרצל

ליעפה ביכרמה

Oxycodone HCl

םיקזוח

ג"מ

היוותה

:

severe chronic pain

ief of moderate

For the rel

תעבראל ףתושמה דחא שי ןכרצל ןולעל עגונב וליאו ,םיקזוחה תשמחל ףתושמ אפורל ןולעה יכ ןייצל שי ( םיהובגה םיקזוחה

ןיטנוקיסקוא רובע דחאו )ג"מ

םיקזוחהש איה וז הדרפהל הביסה . מו םידליב שומישל םירוסא םיהובגה ליג דע םירגבת

ןיטנוקיסקוא לש וזמ הנוש היצלומרופ םהלש רחאמ

.)קזוחה דבלמ(

:םינולעב םייונישה

םידיאויפואה תצובקמ םירישכתה לכל ףיסוהל תואירבה דרשמ תשירדל םאתהב

Black Box

יבגל םיניפזאידוזנב םע היצקארטניא

תויורכמתהו :אבה עדימה היוותהה ינפל םינולעב ףסוה ,

ב

:ןכרצל ןולע

לאיצנטופ תולעב ןניהו ,ךשוממ שומישב רקיעב ,תורכמתהל םורגל תולולע םידיאויפואה תחפשממ תופורת .תוומל םורגל ףאו תיטיא המישנב אטבתהל הלוכי רתי ןונימל הבוגת .רתי ןונימלו הערל שומישל

טה ךשמ ,ןתמה תורידת ,חקול ךנהש ןונימה ,הפורתה םש תא ריכמ ךנה יכ אדוו יאוולה תועפות ,לופי

.םילאיצנטופה םינוכיסהו

:רושיקב אוצמל ןתינ תורכמתהו תולתל ןוכיסה תודוא ףסונ עדימ

/opioids_he.pdf

https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib

תיזכרמ םיבצע תכרעמ תואכדמה תורחא תופורת ,םיניפזאידוזנבה תחפשממ תופורת םע וז הפורת תליטנ )יתמישנ יוכיד( המישנ יישק ,הקומע תוינונשי תשוחתל םורגל הלולע לוהוכלא וא )םימס ללוכ(

.תוומו תמדרת

:אפורל ןולעב

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES

Concomitant use of benzodiazepines and opioids may result in profound sedation,

respiratory depression, coma, and death [see section 4.5].

Reserve concomitant prescribing of these drugs for use in patients for whom alternative

treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

.תויביטדס תופורתל אמגודכ םיניפזאידוזנבה תצובק הפסוה תויתפורת ןיב תובוגתב ,ןכ ומכ

נולעל רושיק ב"צמ .ותומלשב ןולעב ןייעל שי אלמה עדימל .םייונישה םינמוסמ םהב םי

תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל וחלשנ םינולעה

www.health.gov.il

םלבקל םג ןתינו , :'לטב מ"עב אפר תודבעמ תרבחל הינפ י"ע םיספדומ

5893939

תבותכב וא :ל"אוד

RA@rafa.co.il

,בר דובכב

ץיבוקיוו לכימ 'רגמ

הנוממ תחקור

OxyContin-DL-Feb2013_Jan2019- rev04

Doctor Leaflet

1.

NAME OF THE MEDICINAL PRODUCT

OxyContin

10, 20, 40, 80 Controlled Release Tablets (New Formulation)

OxyContin

5 Controlled Release Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

OxyContin 5 contains 5 mg of oxycodone hydrochloride.

OxyContin 10 contains 10 mg of oxycodone hydrochloride.

OxyContin 20 contains 20 mg of oxycodone hydrochloride.

OxyContin 40 contains 40 mg of oxycodone hydrochloride.

OxyContin 80 contains 80 mg of oxycodone hydrochloride.

For excipients see section 6.1.

3.

PHARMACEUTICAL FORM

Controlled release tablets.

The 5 mg tablets are light blue.

The 10 mg tablets are white.

The 20 mg tablets are pink.

The 40 mg tablets are yellow.

The 80 mg tablets are green.

4.

CLINICAL PARTICULARS

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS

DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS)

depressants, including alcohol, may result in profound sedation, respiratory depression, coma,

and death [see 'Drug Interactions'].

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment

options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

4.1

Therapeutic indications

For the relief of moderate to severe chronic pain.

4.2

Posology and method of administration

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed.

OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure

complete swallowing immediately after placing in the mouth.

Elderly and adults over 18 years:

OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of

the pain, and the patient’s previous history of analgesic requirements.

OxyContin is not intended for use as a prn analgesic.

Increasing severity of pain will require an increased dosage of OxyContin tablets using the 5 mg, 10

mg, 20 mg, 40 mg or 80 mg tablet strengths, either alone or in combination, to achieve pain relief. The

correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12

hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent

this. If higher doses are necessary increases should be made, where possible, in 25% - 50%

increments. The need for escape medication more than twice a day indicates that the dosage of

OxyContin tablets should be increased.

The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled

by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to

minimise the incidence of side effects. The dose should then be carefully titrated, as frequently as once

a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12-

hourly. However, a few patients may require higher doses. Doses in excess of 1000 mg have been

recorded.

Patients receiving oral morphine before OxyContin therapy should have their daily dose based on the

following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be

emphasised that this is a guide to the dose of OxyContin tablets required. Inter-patient variability

requires that each patient is carefully titrated to the appropriate dose.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that,

compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward

adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are

appropriate.

Pediatric use

OxyContin 10, 20, 40, 80: should not be used in patients under 18 years of age.

OxyContin 5: Safety and effectiveness of OxyContin in pediatric patients below the age of 18 years

have not been established.

Adults with mild to moderate renal impairment and mild hepatic impairment:

The plasma concentration in this population may be increased. Therefore dose initiation should

follow a conservative approach. Patients should be started on OxyContin 5 mg 12-hourly or

oxycodone HCl liquid 2.5 mg 6-hourly and titrated to pain relief as described above.

Use in non-malignant pain:

Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the

only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids

include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment

in non-malignant pain should be assessed at regular intervals.

Cessation of therapy:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose

gradually to prevent symptoms of withdrawal.

4.3

Contraindications

Hypersensitivity to any of the constituents, respiratory depression, head injury, known or suspected

paralytic ileus and GI obstruction, acute abdomen, delayed gastric emptying, chronic obstructive

airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known oxycodone sensitivity or

in any situation where opioids are contra-indicated, moderate to severe hepatic impairment, severe

renal impairment (creatinine clearance

10 ml/min), chronic constipation, concurrent administration of

monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for

pre-operative use or for the first 24 hours post-operatively. Patients with rare hereditary problems of

galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not

take the 5 mg strength. Pregnancy.

4.4

Special warnings and precautions for use

The major risk of opioid excess is respiratory depression.

Closely monitor patients for respiratory

depression when initiating therapy with OxyContin and following dose increases.

Instruct patients on proper administration of OxyContin tablets to reduce the risk

As with all narcotics, a reduction in dosage may be advisable in hypothyroidism.

Use with caution in patients with raised intracranial pressure, hypotension, hypovolaemia, toxic

psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic

hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic

disease or severe pulmonary disease, and debilitated, elderly patients.

The oxycodone in OxyContin may aggravate convulsions in patients with convulsive disorders, and

may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure

disorders for worsened seizure control during OxyContin therapy.

OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. Should

paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued

immediately. As with all opioid preparations, patients about to undergo additional pain relieving

procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to

the intervention. If further treatment with OxyContin tablets is indicated then the dosage should be

adjusted to the new post-operative requirement.

OxyContin 80 mg should not be used in patients not previously exposed to opioids. This tablet

strength may cause fatal respiratory depression when administered to opioid naïve patients.

As with all opioid preparations, OxyContin tablets should be used with caution following abdominal

surgery as opioids are known to impair intestinal motility and should not be used until the physician is

assured of normal bowel function.

For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of

a comprehensive treatment programme involving other medications and treatment modalities. A crucial

part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and

substance abuse history. There is potential for development of psychological dependence

(addiction) to opioid analgesics, including oxycodone. OxyContin tablets, like all opioids, should be

avoided in patients with a history of, or present alcohol and drug abuse.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to

minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a

minimum of side effects. There must be frequent contact between physician and patient so that dosage

adjustments can be made. It is strongly recommended that the physician defines treatment outcomes

in accordance with pain management guidelines. The physician and patient can then agree to

discontinue treatment if these objectives are not met.

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur in

particular in high doses. An oxycodone dose reduction or change in opioid may be required.

OxyContin has an abuse profile similar to other strong opioids. Oxycodone may be sought and

abused by people with latent or manifest addiction disorders.

As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms

and may have respiratory depression at birth.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. The administration

of broken, chewed or crushed OxyContin tablets leads to a rapid release and absorption of a

potentially fatal dose of oxycodone (see Section 4.9).

OxyContin 10, 20, 40, 80: There have been post-marketing reports of difficulty in swallowing

OxyContin tablets. These reports included choking, gagging, regurgitation and tablets stuck in the

throat. Instruct patients not to pre-soak, lick or otherwise wet OxyContin tablets prior to placing in the

mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately

after placing in the mouth. There have been rare post-marketing reports of cases of intestinal

obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to

remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer

with a small gastrointestinal lumen are at greater risk of developing these complications. Use caution

when prescribing OxyContin for patients who have difficulty swallowing or have underlying GI

disorders that may predispose them to obstruction. Consider use of an alternative analgesic in

patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a

small gastrointestinal lumen.

Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin;

concomitant use should be avoided.

Abuse of the tablets by parenteral administration can be expected to result in other serious adverse

events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis,

and valvular heart injury, which may be fatal.

4.5

Interaction with other medicinal products and other forms of interaction

OxyContin, like other opioids, potentiates the effects of tranquillisers, anaesthetics, hypnotics, anti-

depressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and

antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics,

producing CNS excitation or depression with hypertensive or hypotensive crisis.

Concurrent use of OxyContin and other central nervous system (CNS) depressants including

sedatives or hypnotics

such as benzodiazepines

, general anesthetics, phenothiazines, tranquilizers,

and alcohol can increase the risk of respiratory depression, hypotension, profound sedation or coma.

Monitor patients receiving CNS depressants and OxyContin for signs of respiratory depression and

hypotension. When such combined therapy is contemplated, reduce the initial dose of OxyContin and

consider using a lower dose of the concomitant CNS depressant.

Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be

avoided.

Mixed Agonist/Antagonist Opioid Analgesics (i.e., pentazocine, nalbuphine, and butorphanol) - should

generally not be administered to a patient who has received or is receiving a course of therapy with a

pure opioid agonist analgesic such as OxyContin. In this situation, mixed agonist/antagonist

analgesics may reduce the analgesic effect of oxycodone and may precipitate withdrawal symptoms in

these patients.

Diuretics - opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic

hormone. opioids may also lead to acute retention of urine by causing spasm of the sphincter of the

bladder, particularly in men with enlarged prostates.

Anticholinergics or other medications with anticholinergic activity - when used concurrently with

opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which

may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility

when OxyContin is used concurrently with anticholinergic drugs.

Oxycodone is metabolized in part via the CYP2D6 and CYP3A4 pathways. The activities of these

metabolic pathways may be inhibited or induced by various co-administered drugs or dietary

elements. Oxycodone doses may need to be adjusted accordingly.

Cimetidine and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., clarithromycin, erythromycin),

azole-antifungal agents (e.g., ketoconazole, voriconazole), and protease inhibitors (e.g., ritonavir),

may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma

concentrations.

CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of

oxycodone and cause increased clearance of the drug, resulting in a decrease in oxycodone plasma

concentrations.

Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased

clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.

4.6

Pregnancy and lactation

OxyContin tablets are not recommended for use in pregnancy nor during labour. Infants born to

mothers who have received opioids during pregnancy should be monitored for respiratory depression.

Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn.

OxyContin tablets should, therefore, not be used in breast-feeding mothers.

4.7

Effects on ability to drive and use machines

Oxycodone may modify patients’ reactions to a varying extent depending on the dosage and individual

susceptibility. Therefore patients should not drive or operate machinery if affected.

4.8

Undesirable effects

Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see

Tolerance and Dependence, below). Constipation may be prevented with an appropriate laxative. If

nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic.

Common (incidence of

1%) and uncommon (incidence of

1%) adverse drug reactions are listed in

the table below.

Body System

Common

Uncommon

Immune system disorders

Anaphylactic reaction

Anaphylactoid reaction

Hypersensitivity

Metabolism and nutritional

disorders

Decreased appetite

Dehydration

Anorexia

Psychiatric disorders

Anxiety

Affect lability

Confusional state

Agitation

Insomnia

Drug dependence

Nervousness

Euphoric mood

Thinking abnormal

Hallucination

Body System

Common

Uncommon

Abnormal dreams

Libido decreased

Depression

Disorientation

Mood altered

Restlessness

Dysphoria

Nervous system disorders

Headache

Amnesia

Dizziness

Hypertonia

Sedation

Hypoaesthesia

Somnolence

Hypotonia

Tremor

Paresthesia

Speech disorder

Convulsions

Muscle contractions involuntary

Dysgeusia

Syncope

Hyperalgesia

Eye disorders

Miosis

Vision impairment

Ear and labyrinth disorders

Vertigo

Tinnitus

Cardiac disorders

Supraventricular tachycardia

Vascular disorders

Hypotension

Orthostatic hypotension

Vasodilatation

Facial flushing

Respiratory, thoracic and

mediastinal disorders

Bronchospasm

Dyspnoea

Respiratory depression

Hiccups

Cough decreased

Gastrointestinal disorders

Constipation

Nausea

Vomiting

Dry mouth

Dyspepsia

Abdominal Pain

Diarrhoea

Dental caries

Dysphagia

Eructation

Flatulence

Ileus

Gastritis

Hepato-biliary disorders

Biliary colic

Cholestasis

Hepatic enzyme increased

Skin and subcutaneous tissue

disorders

Hyperhidrosis

Pruritus

Rash

Dry skin

Exfoliative dermatitis

Musculoskeletal and

connective tissue disorders

Muscular rigidity

Renal and urinary disorders

Urinary retention

Ureteral spasm

Reproductive system and

Amenorrhoea

Body System

Common

Uncommon

breast disorders

Erectile dysfunction

General disorders and

administration site conditions

Asthenic conditions

Drug tolerance

Oedema

Oedema peripheral

Malaise

Thirst

Pyrexia

Drug withdrawal syndrome

Chills

Lymphadenopathy

Chest pain

ST depression ( investigations)

OxyContin 10, 20, 40, 80: The following have also been reported, potentially due to the swelling and

hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and

difficulty swallowing the tablet.

Tolerance and Dependence:

The patient may develop tolerance to the drug with chronic use and require progressively higher

doses to maintain pain control. Prolonged use of OxyContin tablets may lead to physical

dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a

patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to

prevent symptoms of withdrawal. The opioid abstinence or withdrawal syndrome is characterised by

some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills,

myalgia, mydriasis and palpitations. Other symptoms also may develop, including: irritability,

anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting,

diarrhoea, or increased blood pressure, respiratory rate or heart rate.

Postmarketing Experience:

The following adverse reactions have been identified during post-approval use of controlled-release

oxycodone: abuse, addiction, amenorrhea, cholestasis, death, dental caries, increased hepatic

enzymes, hyperalgesia, hyponatremia, ileus, muscular hypertonia, overdose, palpitations (in the

context of withdrawal), seizures, syndrome of inappropriate antidiuretic hormone secretion, and

urticaria.

Anaphylaxis has been reported with ingredients contained in OxyContin. Advise patients how to

recognize such a reaction and when to seek medical attention.

4.9

Overdose

Signs of oxycodone toxicity and overdose are miosis, respiratory depression, hypotension and

hallucinations. Circulatory failure and somnolence progressing to stupor or deepening coma,

hypotonia, bradycardia, and death may occur in more severe cases.

The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or other

psychotropic drugs.

Treatment of oxycodone overdosage: Primary attention should be given to the establishment of a

patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and

0.01 mg/kg body weight for children), if the patient is in a coma or respiratory depression is present.

Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an

infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50

ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical

response). Infusions are not a substitute for frequent review of the patient’s clinical state. Intramuscular

naloxone is an alternative in the event IV access is not possible. As the duration of action of naloxone

is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-

established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously

poisoned patients.

For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1

mg every 2 minutes if required.

The patient should be observed for at least 6 hours after the last dose of naloxone.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory

depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to

persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an

abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

Consider activated charcoal (50 g for adults, 10 -15 g for children), if a substantial amount has

been ingested within 1 hour, provided the airway can be protected. It may be reasonable to

assume that late administration of activated charcoal may be beneficial for prolonged release

preparations; however there is no evidence to support this.

OxyContin tablets will continue to release and add to the oxycodone load for up to 12 hours

after administration and management of oxycodone overdosage should be modified

accordingly. Gastric contents may need to be emptied as this can be useful in removing

unabsorbed drug, particularly when a prolonged release formulation has been taken.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids

ATC code: NO2A AO5

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and

delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The

therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that can

be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.

Clinical symptoms may be manifest from these hormonal changes.

Other pharmacological effects

In- vitro and animal studies indicate various effects of natural opioids, such as morphine, on

components of the immune system; the clinical significance of these findings is unknown. Whether

oxycodone, a semisynthetic opioid, has immunological effects similar to morphine is unknown.

Clinical studies

The efficacy of OxyContin tablets has been demonstrated in cancer pain, post-operative pain and

severe non-malignant pain such as diabetic neuropathy, postherpetic neuralgia, low back pain and

osteoarthritis. In the latter indication, treatment was continued for up to 18 months and proved effective

in many patients for whom NSAIDs alone provided inadequate relief. The efficacy of OxyContin tablets

in neuropathic pain was confirmed by three placebo-controlled studies.

In patients with chronic non-malignant pain, maintenance of analgesia with stable dosing was

demonstrated for up to three years.

5.2

Pharmacokinetic properties

Following absorption, oxycodone is distributed throughout the entire body. Approximately 45% is

bound to plasma protein. Oxycodone is metabolized in the liver via CYP3A4 and CYP2D6 to

noroxycodone, oxymorphone and noroxymorphone, which are subsequently glucuronidated.

Noroxycodone and noroxymorphone are the major circulating metabolites. Noroxycodone is a weak

mu opioid agonist. Noroxymorphone is a potent mu opioid agonist; however, it does not cross the

blood-brain barrier to a significant extent.

Oxymorphone is a potent mu opioid agonist but is present

at very low concentrations following oxycodone administration. None of these metabolites are

thought to contribute significantly to the analgesic effect of oxycodone.

Compared with morphine, which has an absolute bioavailability of approximately 30%, oxycodone has

a high absolute bioavailability of up to 87% following oral administration. Oxycodone has an

elimination half-life of approximately 3 hours and is metabolised principally to noroxycodone and

oxymorphone. Oxymorphone has some analgesic activity but is present in the plasma in low

concentrations and is not considered to contribute to oxycodone’s pharmacological effect.

The release of oxycodone from OxyContin tablets is biphasic with an initial relatively fast release

providing an early onset of analgesia followed by a more controlled release which determines the 12

hour duration of action. The mean apparent elimination half-life of OxyContin is 4.5 hours which leads

to steady-state being achieved in about one day.

Release of oxycodone from OxyContin tablets is independent of pH.

OxyContin tablets have an oral bioavailability comparable with conventional oral oxycodone, but the

former achieve maximal plasma concentrations at about 3 hours rather than about 1 to 1.5 hours.

Peak and trough concentrations of oxycodone from OxyContin tablets 10 mg administered 12-hourly

are equivalent to those achieved from conventional oxycodone 5 mg administered 6-hourly.

OxyContin tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg are bioequivalent in terms of both rate and

extent of absorption. Ingestion of a standard high-fat meal does not alter the peak oxycodone

concentration or the extent of oxycodone absorption from OxyContin tablets.

Elderly

The AUC in elderly subjects is 15% greater when compared with young subjects.

Gender

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on

a body weight adjusted basis. The reason for this difference is unknown.

Patients with renal impairment

Preliminary data from a study of patients with mild to moderate renal dysfunction show peak plasma

oxycodone and noroxycodone concentrations approximately 50% and 20% higher, respectively and

AUC values for oxycodone, noroxycodone and oxymorphone approximately 60%, 60% and 40%

higher than normal subjects, respectively. There was an increase in t

of elimination for oxycodone of

only 1 hour.

Patients with mild to moderate hepatic impairment

Patients with mild to moderate hepatic dysfunction showed peak plasma oxycodone and noroxycodone

concentrations approximately 50% and 20% higher, respectively, than normal subjects. AUC values

were approximately 95% and 75% higher, respectively. Oxymorphone peak plasma concentrations

and AUC values were lower by 15% to 50%. The t

elimination for oxycodone increased by 2.3 hours.

5.3

Preclinical safety data

Teratogenicity

Oxycodone had no effect on fertility or early embryonic development in male and female rats at

doses as high as 8 mg/kg/d. Also, oxycodone did not induce any deformities in rats at doses as high

as 8 mg/kg/d or in rabbits at doses as high as 125 mg/kg/d. Dose-related increases in

developmental variations (increased incidences of extra (27) presacral vertebrae and extra pairs of

ribs) were observed in rabbits when the data for individual fetuses were analyzed. However, when

the same data were analyzed using litters as opposed to individual fetuses, there was no dose-

related increase in developmental variations although the incidence of extra presacral vertebrae

remained significantly higher in the 125 mg/kg/d group compared to the control group. Since this

dose level was associated with severe pharmacotoxic effects in the pregnant animals, the fetal

findings may have been a secondary consequence of severe maternal toxicity.

In a study of peri- and postnatal development in rats, maternal body weight and food intake

parameters were reduced for doses ≥ 2 mg/kg/d compared to the control group. Body weights were

lower in the F1 generation from maternal rats in the 6 mg/kg/d dosing group. There were no effects

on physical, reflexological, or sensory developmental parameters or on behavioural and reproductive

indices in the F1 pups (the NOEL for F1 pups was 2 mg/kg/d based on body weight effects seen at 6

mg/kg/d). There were no effects on the F2 generation at any dose in the study.

Carcinogenicity

Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted

owing to the length of clinical experience with the drug substance.

Mutagenicity

The results of in-vitro and in-vivo studies indicate that the genotoxic risk of oxycodone to humans is

minimal or absent at the systemic oxycodone concentrations that are achieved therapeutically.

Oxycodone was not genotoxic in a bacterial mutagenicity assay or in an in-vivo micronucleus assay

in the mouse. Oxycodone produced a positive response in the in-vitro mouse lymphoma assay in

the presence of rat liver S9 metabolic activation at dose levels greater than 25 μg/mL. Two in-vitro

chromosomal aberrations assays with human lymphocytes were conducted. In the first assay,

oxycodone was negative without metabolic activation but was positive with S9 metabolic activation at

the 24 hour time point but not at other time points or at 48 hour after exposure. In the second assay,

oxycodone did not show any clastogenicity either with or without metabolic activation at any

concentration or time point.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Magnesium stearate

Hypromellose

Titanium dioxide

Macrogol

In addition the tablets contain the following:

OxyContin 5 contains: Brilliant blue (E133), lactose, povidone, talc, ammonio methacrylate co-

polymer, glyceryl triacetate, stearyl alcohol.

OxyContin 10 contains: Hydroxypropylcellulose, polyethylene oxide.

OxyContin 20 contains: Polysorbate 80, red iron oxide (E172), polyethylene oxide.

OxyContin 40 contains: Polysorbate 80, yellow iron oxide (E172), polyethylene oxide.

OxyContin 80 contains: Hydroxypropylcellulose, yellow iron oxide (E172), indigo carmine

(E132), polyethylene oxide.

6.2

Incompatibilities

Not applicable

6.3

Special precautions for storage

Do not store above 25

6.4

Nature and contents of container

PVC blister packs with aluminium foil backing containing 20 tablets.

6.5

Special precautions for disposal and other handling

None.

7.

Marketing authorisation holder and numbers

OxyContin 5 1317530830 (This strength is manufactured by Napp Pharmaceuticals, England).

OxyContin 10 1007128431

OxyContin 20 1007028432

OxyContin 40 1090129255

OxyContin 80 1089829256

Rafa Laboratories Ltd. POB 405, Jerusalem 9100301

The format of this leaflet was determined by the Ministry of Health and its content was checked and

approved in February 2013.

ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע

-

1986

הפורת

קוושמ

דבלב אפור םשרמ יפ לע

יסקו

ןיטנו

רקובמ רורחשב תוילבט

:ליעפה רמוחה

לש הילבט לכ ןיטנוקיסקוא

10

:הליכמ

דירולכורדיה ןודוקיסקוא ג"מ

(Oxycodone hydrochloride)

לש הילבט לכ קוא ןיטנוקיס

20

:הליכמ

דירולכורדיה ןודוקיסקוא ג"מ

(Oxycodone hydrochloride)

לש הילבט לכ ןיטנוקיסקוא

40

:הליכמ

דירולכורדיה ןודוקיסקוא ג"מ

(Oxycodone hydrochloride)

לש הילבט לכ ןיטנוקיסקוא

80

הליכמ

דירולכורדיה ןודוקיסקוא ג"מ

(Oxycodone hydrochloride)

אר םיליעפ יתלבה םיביכרמה תמישרל

ףיעס

הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק

.חקורה לא וא אפורה לא הנפ ,תופסונ תולאש ךל שי םא .הפורתה לע יתיצמת עדימ ליכמ הז ןולע

א וליפא םהל קיזהל הלולע איה .םירחאל התוא ריבעת לא .ךתלחמב לופיטל המשרנ וז הפורת יכ ךל הארנ ם .המוד םתלחמ

יפואה תחפשממ תופורת

די םי

לאיצנטופ תולעב ןניהו ,ךשוממ שומישב רקיעב ,תורכמתהל םורגל תולולע .תוומל םורגל ףאו תיטיא המישנב אטבתהל הלוכי רתי ןונימל הבוגת .רתי ןונימלו הערל שומישל

רידת ,חקול ךנהש ןונימה ,הפורתה םש תא ריכמ ךנה יכ אדוו יאוולה תועפות ,לופיטה ךשמ ,ןתמה תו

םינוכיסהו .םילאיצנטופה

:רושיקב אוצמל ןתינ תורכמתהו תולתל ןוכיסה תודוא ףסונ עדימ

ugs/risk/DocLib/opioids_he.pdf

https://www.health.gov.il/UnitsOffice/HD/MTI/Dr

תואכדמה תורחא תופורת ,םיניפזאידוזנבה תחפשממ תופורת םע וז הפורת תליטנ תא תכרעמ

םיבצע

ללוכ( תיזכרמ )יתמישנ יוכיד( המישנ יישק ,הקומע תוינונשי תשוחתל םורגל הלולע לוהוכלא וא )םימס

.תוומו תמדרת

1

.

?הפורתה תדעוימ המל

הפורתה .םיקזח וא םיינוניב םיכשוממ םיבאכב הלקהל תדעוימ

:תיטיופרת הצובק

םיבאכ יככשמ םידיאויפוא

2

.

הפורתב שומישה ינפל

:םא הפורתב שמתשהל ןיא

ליעפה רמוחל )יגרלא( שיגר התא םא שמתשהל ןיא

םירחא םידיאויפואל

רשא םיפסונה םיביכרמהמ דחא לכל וא ליכמ

רישכתה יביכרמה תמישרל( יתלבה ם

ףיעס האר ,םיליעפ

םא שמתשהל ןיא

התא

)םדב ינצמח וד ןמחפ ףדוע( היברקרפיה ,הרומח תילאיכנורב המטסא ,יתמישנ יוכידמ לבוס תואירה דוקפתב םירומח םייוקילמ וא

ןוגכ

COPD

שמתשהל ןיא םא התא

מ לבוס כ עודיה בצמ( בלה לש ינמיה ודיצב לשכ

cor pulmonale

ב אטבתמה

םד ץחל רת יתאיר

ינמיה רדחה תלדגהו

םא שמתשהל ןיא התא .דבכה דוקפתב רומח דע ינוניב יוקילמ וא הילכה דוקפתב רומח יוקילמ לבוס

םא שמתשהל ןיא התא תוריצע ,יטיא הביק ןוקיר ,רומח ןטב באכ ,םייעמ תמיסחל דשח ,םייעמ תמיסחמ לבוס .תינורכ

םא שמתשהל ןיא מ לבוס התא שאר תעיגפ ב חותינ תרבע וא חותינ ינפל התא םא וא ,

.תונורחאה תועשה

םא רישכתב שמתשהל ןיא התא

לטונ

םויכ

ןימאונומ יבכעמ תחפשממ הפורת

זאדיסקוא

(MAOIs)

וזכ תלטנש וא .םינורחאה םייעובשה ךלהמב

ןיטנוקיסקואב שמתשהל ןיא

.תוידיאויפוא תופורתב שמתשהל לגרומ ךניא םא

תשהל ןיא שמ הפורתב םא תא

.הקינמ וא ןוירהב

ןיטנוקיסקואב שמתשהל ןיא

םידליב םירגבתמבו ליגל תחתמ

:הפורתב שומישל תועגונה תודחוימ תורהזא

שותכל ,סועלל ןיא תוצחל ,סימהל , ל וא רובש

.הילבטה תא

שמתשהל ןיא

הפורתב

הדימב .התומלשב הילבטה תא עולבל לוכי ךניא םא

תעילבב דחוימבו העילבב ישוקמ לבוס התאו .וז הפורתב לופיטה תליחת ינפל לפטמה אפורה תא ךכ לע עדייל שי ,תוילבט

תתל ןיא .הערל שומישל לאיצנטופ תולעב ןניהו ,ידיאויפוא ביכרמ ,ןודוקיסקוא תוליכמ ןיטנוקיסקוא תוילבט .רחא םדאל ןיטנוקיסקוא

טוקנל שי לכ תנמ לע תוריהז יעצמא

הפורתה תעגה עונמל לפוטמה וניאש םדאל

!תולתל םורגל לולע ךשוממ שומיש

עוויהל ילבמ ימואתפ ןפואב וז הפורת לוטיל קיספהל ןיא

יתגרדה ןפואב ןונימה תא תיחפהל שי לופיטה תקספהב .אפורב קב םייוניש ,תוקזח בל תוקיפד ,הדרח ,טקש יא :ןוגכ ,הלימג ינמיס תעפוהמ ענמיהל תנמ לע וא/ו םדה ץחל ,בלה בצ ,בג יבאכ ,םינושיא תבחרה ,םיקרפמו םירירש יבאכ ,)תלזנ ,עמד( רתי תושרפה ,העזה ,תורומרמצ ,דער ,המישנה .לושלש ,ןובאת ןדבוא ,האקה ,הליחב ,הניש ידודנ ,השלוח ,ןטבב תויוצווכתה

לעו לפטמה אפורה תויחנה יפ לע ןיטנוקיסקוא תוילבט תליטנ לע דיפקהל שי

האר( הז ןולעבש תוארוהה יפ

ףיעס

הפורתב שמתשת דציכ

.ףוחד לופיט וא )םייניש ללוכ( חותינ ,המדרהב הכורכה הלועפ לכ ינפל וז הפורת תליטנ לע לפטמה אפורל חוודל ךילע

ופליע םיינוציק םירקמבו תורוחרחס עונמל ידכ ,הדימעל הבישי/הביכש בצממ ימואתפ רבעממ ענמיהל שי

.הפורתל תרבגומה םתושיגר בקע ,םישישקב תשרדנ הבר תוריהז

םא התא לע עידוהל ךילע ,יהשלכ הפורתל וא והשלכ ןוזמל שיגר

.הפורתה תליטנ ינפל אפורל ךכ

ב לופיטה ינפל ןיטנוקיסקוא

אפורל רפס

םא לבוס התא

:דוקפתב יוקילמ רבעב תלבס וא

המטסא ןוגכ( המישנה תכרעמ

גוס לכמ בלה ,)

תטולב ,הרמה סיכ ,דבכה ,)ךומנ םד ץחל דחוימב( םדה ילכ וא/ו ,ןתשה תכרעמ/תוילכה ,לנרדאה תינומרעה תטולב

םא לבוס התא תויעבמ רבעב תלבס וא ,יעמה וא טשוה ןטרס ,ןוגכ לוכיעה תכרעמב םייעמ חותינ תלחמ וא תוריצע , ( תיתקלד יעמ

םא התא

רבעב תלבס וא לבוס קלד ,תותיוועמ רבגומ יתלוגלוג ךות ץחל ,סירתה תטולב לש תוליעפ תת ,בלבלה ת

האצותכ תוישפנ תויעב ,)םיפירח שאר יבאכב ראשה ןיב אטבתהל לוכיש( םיליער םירמוח תעפשהמ

toxic

psychosis

,לוהוכלאל תורכמתה וא תופורת םימס

ימסב וא תופורתב שומיש תקספה תובקעב( הלימג ינימסתמ רבעב תלבס םא :ןוגכ ,)ם יא

טקש וא דער ,הדרח ,

העז

תורחא תופורת הנורחאל תחקל םא וא חקול התא םא

,

ךכ לע רפס ,הנוזת יפסותו םשרמ אלל תופורת ללוכ .חקורל וא אפורל

חקול התא םא חקורה וא אפורה תא עדייל שי דחוימב

תואבה תופורתה תא

המישרה יכ ןייצל שי( ליעפה םירמוחה תא תנייצמ ןלהלש תופורתב םי

.

אנא וללה תופורתהמ תחאב שמתשמ התא םאה חוטב ךניא םא :)חקורה וא אפורה םע ץעייתת

העגרהל תופורת :ןוגכ( תיזכרמה םיבצעה תכרעמ לע תועיפשמה תופורת

הנישל

םיניפזאידוזנב ללוכ ,הדרח תודגונ , וריונ תופורת וא םיניזאיתונפ ןוגכ תוישפנ תוערפהב לופיטל תופורת .)תויטפל

.ןואכיד דגנ תופורת

תופורת תיגרנילוכיטנא תוליעפ תולעב תופורת ,תונתשמ תופורת ,םירירש תייפרהל תופורת ,הובג םד ץחלב לופיטל

)ןוסניקרפב לופיטל לשמל תושמשמ(

.)לוזאנוקירוו ,לוזאנוקוטק :ןוגכ( תוירטפ דגנ תופורת

ה ףיגנ דגנ תופורת

)ריוונוטיר ןוגכ(

ניווק ןידי

)בלב תויעבב לופיטל( ןידיטמיס ,

לוכיע תויעבב לופיטל הפורת(

ןוגכ

)תברצ ,הביק ביכ

.)היספליפאב לופיטל( ןיאוטינפ ,ןיפזמברק

:ןוגכ( םידילורקמה תחפשממ הקיטויביטנא

ןיציפמאפיר ,)ןיצימורתירלק ,ןיצימורתירא

)ןיפמאפיר(

ל תופורת המדרה

תיללכ

א םיבאכ יככשמו ןוסקרטלנ םירחא םידיאויפו

תופור תחפשממ

ןימאונומ יבכעמ

זאדיסקוא

(MAOIs)

.'םא הפורתב שמתשהל ןיא' ףיעס האר

הפורתב שומיש

ןוזמו

.החוראה ינמזל רשק אלל הפורתה תא לוטיל ןתינ

:לוהוכלא תכירצו הפורתב שומיש

תותשל ןיא

לוהוכלא

.וז הפורתב לופיטה תפוקתב

ןמזב לוהוכלא תייתש

הלולע הפורתב שומישה יאוול תועפותל ןוכיסה תא ריבגהל וא ינונשי רתוי שיגרהל ךל םורגל תורומח יישק ןוגכ .הרכהה דוביאו ,המישנ תקספהל ןוכיס םע המישנ

:הקנהו ןוירה

שמתשהל ןיא הפורתב םא תא

.הקינמ וא ןוירהב

תונוכמב שומישו הגיהנ

:

ונרעב םוגפל לולע וז הפורתב שומישה לכבו תונכוסמ תונוכמ תלעפהב ,בכרב הגיהנב תוריהז בייחמ ןכ לעו ת .תונרע תבייחמה תוליעפ

:םידליב שומיש ןיטנוקיסקואב שמתשהל ןיא

םידליב םירגבתמבו ליגל תחתמ

3

?הפורתב שמתשת דציכ .

.אפורה תוארוה יפל שמתשהל שי דימת

חקורה וא אפורה םע קודבל ךילע

חוטב ךניא םא

לופיטה ןפואו ןונימה

אפורה ידי לע ועבקי דבלב

אוה ללכ ךרדב לבוקמה ןונימה

ללכ ךרדב אוה יתלחתהה ןונימה

לכ ג"מ

.תועש ( םיבוצק םינמזב הפורתה תא לוטיל שי ללכ ךרדב לכ

ש יפכ ,)תועש קיי לע עב

.לפטמה אפורה ידי .רתוי תופוכת םיתיעל וז הפורתב שמתשהל ןיא תא םיאתי אפורה .ךלש באכב לופיטל םיאתיש ןונימה

תצלמומה הנמה לע רובעל ןיא

לפטמה אפורה םע תוצעייתה אלל ןונימה תא תונשל ןיא

באכ שוחל ךישממ התא ,הפורתב לופיטה ךלהמב םא

הנפ .אפורל

ךניה םא לפטמה אפורל חוודל שי ןכ ומכ .ץרפתמ באכ לש םיעוריא הווח

,שותכל ,סועלל ןיא ,סימהל !הילבטה תא רובשל וא תוצחל

עולבל שי םימ סוכ םע תומלשב הילבטה תא

הגיפסה תרחא םורגלו רתוי הריהמ תויהל הלוכי

יאוול תועפות ןוגכ תורומח

רתי ןונימ

ףיעס האר(

םא תלטנ

רתוי הובג ןונימ תועטב

טה תא קיזחהל ןיא .התעילבל שורדה ןמזל רבעמ הפב הילב

:הילבטהמ תוקנתשהל ןוכיסה תא תיחפהל תנמ לע

.הפב התוא םימשש ינפל ,הילבטה תא קקלל וא ביטרהל ןיא

םע )הנמל תחא הילבטמ רתוי לוטיל הרוה אפורה םהב םירקמב םג( דרפנב הילבט לכ עולבל דיפקהל שי העילב חיטבהל תנמ לע ,םימ לש תקפסמ תומכ .הילבטה לש תידיימו המלש

וא( האוצב תאצל הלולע הילבטה לש הקירה תינבתהו ףוגב התוהש ךלהמב הילבטהמ הגרדהב ררחתשמ ליעפה רמוחה .ףוגב גפסנ רבכ ליעפה רמוחהש רחאמ ,הגאד תררועמ הניא וז העפות .)סגה יעמה חותינ רחאל ,תיקשב

:בקעמו תוקידב

ובעל ךילע ,חווט ךורא לופיט ךלהמב ךשמתמה ךרוצה תא ךירעהל תנמ לע ,תויתפוקת תוכרעה ר הפורתב

םא תלטנ

רתוי הובג ןונימ תועטב

וא עלב תועטב םא תא הפורתה

רחא םדא לכ וא דלי

תונפל שי אפורל דימ םילוח תיב לש ןוימ רדחל וא תא איבהלו .הפורתה תזירא

רתי ןונימ ינימסת םייושע

:לולכל

תוליחב תואקה/

תורוחרחס

ןושיאה תורציה ,םדה ץחלב הדירי ,

,תויזה ןכ ומכ .בר םונמנ םירומח םירקמב עיפוהל םילולע יישק המישנ םורגל םילולעש

הרכה ןדבואל

.הפוחד תיאופר הרזע םישרוד הלא םינימסת

תחכש םא ה תא לוטיל הפורת

:

ךות תרכזנו הדימב

ןמזהמ תועש

ייה וב

הפורתה תא תחקל רומא מ התוא חק , .ליגרה ןמזב חק האבה הנמה תא .די

מ רתוי ורבע םא

תועש ,הפורתה תא תחקל רומא תייה וב ןמזהמ

אפורב ץעוויהל שי

לוטיל ןיא

הלופכ הנמ

החכשנש הנמה לע תוצפל ידכ

.אפורה ידי לע ץלמוהש יפכ לופיטב דימתהל שי

,ךתואירב בצמב רופיש לח םא םג

ה אלל הפורתב לופיטה קיספהל ןיא חקורה וא אפורה םע תוצעיית

קר זא םגו יתגרדה ןפואב

םא :הפורתה תליטנ תא קיספמ התא

ל קיספהל ןיא

.תאז הרוה אפורה םא אלא ,תימואתפב הפורתה תא לוט הווחת אלש ידכ תאז תושעל דציכ ךתוא החניש אפורב ץעייתהל שי ,הפורתה תליטנ תא קיספהל הצור התא םא ינימסת ןוגכ הלימג

,דער ,המישנה וא/ו םדה ץחל ,בלה בצקב םייוניש ,תוקזח בל תוקיפד ,הדרח ,טקש י תויוצווכתה ,בג יבאכ ,םינושיא תבחרה ,םיקרפמו םירירש יבאכ ,)תלזנ ,עמד( רתי תושרפה ,העזה ,תורומרמצ ליחב ,הניש ידודנ ,השלוח ,ןטבב תו אקה , תו .לושלש ,ןובאת ןדבוא ,

!ךשוחב תופורת לוטיל ןיא

הנמהו תיוותה קודב םעפ לכב

התאש

םא םייפקשמ בכרה .הפורת לטונ התא

.םהל קוקז

.חקורב וא אפורב ץעוויה ,הפורתב שומישל עגונב תופסונ תולאש ךל שי םא

4

.

יאוול תועפות

.םישמתשמהמ קלחב יאוול תועפותל םורגל לולע ןיטנוקיסקואב שומישה ,הפורת לכב ומכ ןניא יאוולה תועפות םא תודירטמ ןהש וא תופלוח

תורימחמ ןהש וא .אפורה םע ץעייתהל שי ,

יאוולה תועפות תמישר ארקמל להבית לא

אלו ןכתי .ןהמ תחא ףאמ לובסת

שי

דימ תונפל

אפורל

וימ רדחל וא

ן

םילוח תיבב

תואבה יאוולה תועפות תועיפומ םא

:

וא תיגרלא הבוגת ( תיטקליפנא

תאטבתמ

המישנ יישק

תוחיפנ

זאב רו

םינפה

הו םיבחרנ םירוזאב דרגו החירפ ,ןורג

,םיסוכריפ יתמישנ יוכיד

ןטב יבאכ ,העונתב תוערפה ,קומע םונמנ ,ןורכיזב תוערפה ,לובלב ,השלחו תיטיא המישנ ,תושבייתה ,ןתש תלטהב ישוק וא הנתשהב הדירי ,ריהמ בל בצק ,הרכה דוביא ,םד ץחלב הדירי ,םייעמ תמיסח ,םיקזח ומ העיז תורומרמצ וא תרבג

הבישח תוערפה ,תויזה ,םינטקומ םינושיא

תיאופר הרזע תלבקל דימ תונפל שי

וא/ו ןורגב תעקתנ הילבטה םהב םיבצמ ללוכ ,הילבטה תעילבב םיישק עיפוהב .תוקנתשהל תמרוג

יאוול תועפות תובורק םיתיעל תועיפומה

תועיפומ

מ רתוי

ךותמ

:)םילפוטמ

רה( תוריצע ךל םושרל לוכי אפו ,תואקה ,תוליחב ,לושלש ,ןטבב תוחונ רסוח וא ןטב יבאכ ,לוכיעב תויעב ,הפב שבוי ,)תלשלשמ הפורת ןדבוא ,ןובאית ,היסקרונא ,תונבצע ,םונמנ ,ןואכיד

,הדרח דער

,שאר באכ ,המישנ יישק ,המישנ רצוק ,םיפוצפצ ,לועישה סקלפרב הדירי

תרוחרחס

וא הליגר אל תופייע

,הניש יישק ,השלוח ,לובלב לש תועפות וא/ו דוריג ,םיליגר אל תומולחו תובשחמ ,העזה יוריג וא החירפ ןוגכ רתי תושיגר

יאוול תועפות תוקוחר םיתיעל תועיפומה מ תוחפב תועיפומ(

ךותמ

)םילפוטמ

,חור בצמב םייוניש תשגרה

ןופלע

,תרומרמצ

םיסוכריפ

יא ,םעטב םייוניש

טקש ,הזחב םיבאכ ,באכל רתי תושיגר , ,םדה ץחלב הדירי ,תויזה בל תוקיפד תוליגר אל וא תוריהמ

,תושבייתה

,תמזגומ החמש תשוחת

,םישנב רוזחמ רדעה ,תונוא ןיא ,ינימה קשחב הדירי ,תוקצב ,אמצ ,הקמסה ,רועה תוימומדא

,תולדגומ הפמיל תוטולב

ילגרה תופכ וא םיילוסרקה ,םיידיה תוחפנתה ,םי תוערפה

,היאר

,החונמ רסוח ,וגיטרו ,םיינזואב םילוצליצ ,תואצמתה רסוח וא רורקד ,עגמ וא באכל תויתשוחתב הדירי ,השוחת רסוח ,םוח ,רובידב תוערפה

,ןורכיזב תוערפה

,םיזג ,םירירשה חתמ יונישו תויוצווכתה

,םיקוהיש ,העילב יי ,תינבצע הביק ןוגכ לוכיעה תכרעמב תויעב

ערפה הרמה יכרדב תו

רועב דרגב אטבתהל תולוכיש(

ןתש ,רועה תבהצה ,)תרוויח האוצ ,ההכ

,הביקב תקלד ,ןתש תלטהב ישוק

,ןתש תריצא ,תששע

,םינושיאה לדוגב הדירי

,דבכ ימיזנאב הילע עטקמ( ג.ק.א תקידבב םייוניש ,ןרתנ תומרב הדירי

,רועה לש ףירח ףוליק ,רועב שבוי, )

,הירקיטרוא

תיפ חו תוליבס

תולת

,הפורתב

.הער תיללכ השוחת

ובש הרקמ לכב התא

ץעייתהל ךילע תיללכה ךתשגרהב יוניש לח םא וא ,הז ןולעב וניוצ אלש יאוול תועפות שיגרמ דימ אפורה םע

5

?הפורתה תא ןסחאל ךיא .

וז הפורת !הלערה ענמ

י לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכ לעו תוקונית וא/ו םידל

ךכ ידי הלערה ענמת

.אפורהמ תשרופמ הארוה אלל האקהל םורגת לא

ל דוע קוקז ךניא רשאכ תוילבט ה , .ןקוליס ןפוא לע חקורה םע ץעיית

( הגופתה ךיראת ירחא הפורתב שמתשהל ןיא

(exp. date

םויל סחייתמ הגופתה ךיראת .הזיראה יבג לע עיפומה שדוח ותוא לש ןורחאה

ןסחאל שי :ןוסחא יאנת ל תחתמ

6

ףסונ עדימ

ליעפה רמוחה לע ףסונ

,

תוילבטה

ליכמ תו

יתלבה םירמוחה תא םג

:םיאבה םיליעפ

Polyethylene oxide, magnesium stearate, hypromellose, titanium dioxide, macrogol.

,ףסונב

לש הילבט לכ

ןיטנוקיסקוא

10

:הליכמ

Hydroxypropylcellulose

הילבט לכ

ןיטנוקיסקוא לש

20

:הליכמ

red iron oxide (E172)

Polysorbate 80

הילבט לכ

ןיטנוקיסקוא לש

40

:הליכמ

Polysorbate 80, yellow iron oxide (E172)

הילבט לכ

ןיטנוקיסקוא לש

80

הליכמ

indigo carmine (E132), yellow iron oxide(E172)

Hydroxypropylcellulose

?הזיראה ןכות המו הפורתה תיארנ דציכ

ןיטנוקיסקוא

10

עבצב תוילבט : ןבל תזיראב ,

לש תוישגמ

.תוילבט

ןיטנוקיסקוא

20

לש תוישגמ תזיראב ,דורו עבצב תוילבט

.תוילבט

ןיטנוקיסקוא

40

לש תוישגמ תזיראב ,בוהצ עבצב תוילבט :

.תוילבט

ןיטנוקיסקוא

80

לבט : ראב ,קורי עבצב תוי תזי

לש תוישגמ

.תוילבט

:םושירה לעב

.ד.ת ,מ"עב אפר תודבעמ

םילשורי ,

91003

:תואירבה דרשמב יתכלממה תופורתה סקנפב הפורתה םושיר רפסמ

ןיטנוקיסקוא

10

1007128431

ןיטנוקיסקוא

20

1007028432

ןיטנוקיסקוא

40

1090129255

ןיטנוקיסקוא

80

1089829256

ב תואירבה דרשמ י"ע רשואו קדבנ הז ןולע יאמ

2013

.םינימה ינשל תדעוימ הפורתה ךא ,רכז ןושלב חסונ הז ןולע האירקה תלקהו תוטשפה םשל

I-921005

ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע

-

1986

הפורת

קוושמ

דבלב אפור םשרמ יפ לע

ןיטנוקיסקוא

5

רקובמ רורחשב תוילבט

:ליעפה רמוחה

:הליכמ הילבט לכ

דירולכורדיה ןודוקיסקוא ג"מ

(Oxycodone hydrochloride)

אר םיליעפ יתלבה םיביכרמה תמישרל

ףיעס

םג האר

ףיעסב 'הפורתה לש םיביכרמהמ קלח לע בושח עדימ'

הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק

.חקורה לא וא אפורה לא הנפ ,תופסונ תולאש ךל שי םא .הפורתה לע יתיצמת עדימ ליכמ הז ןולע

א םהל קיזהל הלולע איה .םירחאל התוא ריבעת לא .ךתלחמב לופיטל המשרנ וז הפורת יכ ךל הארנ םא וליפ .המוד םתלחמ

יפואה תחפשממ תופורת

די םי

לאיצנטופ תולעב ןניהו ,ךשוממ שומישב רקיעב ,תורכמתהל םורגל תולולע .תוומל םורגל ףאו תיטיא המישנב אטבתהל הלוכי רתי ןונימל הבוגת .רתי ןונימלו הערל שומישל

חקול ךנהש ןונימה ,הפורתה םש תא ריכמ ךנה יכ אדוו יאוולה תועפות ,לופיטה ךשמ ,ןתמה תורידת ,

םינוכיסהו .םילאיצנטופה

:רושיקב אוצמל ןתינ תורכמתהו תולתל ןוכיסה תודוא ףסונ עדימ

MTI/Drugs/risk/DocLib/opioids_he.pdf

https://www.health.gov.il/UnitsOffice/HD/

https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_he.pdf

הפורת תליטנ

תואכדמה תורחא תופורת ,םיניפזאידוזנבה תחפשממ תופורת םע וז תא תכרעמ

םיבצע

ללוכ( תיזכרמ )יתמישנ יוכיד( המישנ יישק ,הקומע תוינונשי תשוחתל םורגל הלולע לוהוכלא וא )םימס

.תוומו תמדרת

1

?הפורתה תדעוימ המל .

הפורתה

.םיקזח וא םיינוניב םיכשוממ םיבאכב הלקהל תדעוימ

:תיטיופרת הצובק

םיבאכ יככשמ םידיאויפוא

2

הפורתב שומישה ינפל .

:םא הפורתב שמתשהל ןיא

ליעפה רמוחל )יגרלא( שיגר התא םא שמתשהל ןיא

םירחא םידיאויפואל ליכמ רשא םיפסונה םיביכרמהמ דחא לכל וא

יביכרמה תמישרל( רישכתה ףיעס האר ,םיליעפ יתלבה ם

םא שמתשהל ןיא

התא

וא )םדב ינצמח וד ןמחפ ףדוע( היברקרפיה ,הרומח תילאיכנורב המטסא ,יתמישנ יוכידמ לבוס תואירה דוקפתב םירומח םייוקילמ

ןוגכ

COPD

םא שמתשהל ןיא התא

כ עודיה בצמ( בלה לש ינמיה ודיצב לשכמ לבוס

cor pulmonale

יב אטבתמה יתאיר םד ץחל רת .)ינמיה רדחה תלדגהו

םא שמתשהל ןיא התא .דבכה דוקפתב רומח דע ינוניב יוקילמ וא הילכה דוקפתב רומח יוקילמ לבוס

םא שמתשהל ןיא התא .תינורכ תוריצע ,יטיא הביק ןוקיר ,רומח ןטב באכ ,םייעמ תמיסחל דשח ,םייעמ תמיסחמ לבוס

םא שמתשהל ןיא מ לבוס התא שאר תעיגפ ב חותינ תרבע וא חותינ ינפל התא םא וא ,

.תונורחאה תועשה

םא רישכתב שמתשהל ןיא התא

לטונ

םויכ

ןימאונומ יבכעמ תחפשממ הפורת

זאדיסקוא

(MAOIs)

וזכ תלטנש וא .םינורחאה םייעובשה ךלהמב

שמתשהל ןיא הפורתב םא תא

.הקינמ וא ןוירהב

ורתב שומישל תועגונה תודחוימ תורהזא :הפ

שותכל ,סועלל ןיא תוצחל ,סימהל , ל וא רובש

.הילבטה תא

שמתשהל ןיא

הפורתב

.התומלשב הילבטה תא עולבל לוכי ךניא םא

ןיטנוקיסקוא תתל ןיא .הערל שומישל לאיצנטופ תולעב ןניהו ,ידיאויפוא ביכרמ ,ןודוקיסקוא תוליכמ ןיטנוקיסקוא תוילבט .רחא םדאל

טוקנל שי לכ ע תוריהז יעצמא הפורתה תעגה עונמל תנמ ל לפוטמה וניאש םדאל

!תולתל םורגל לולע ךשוממ שומיש

יתגרדה ןפואב ןונימה תא תיחפהל שי לופיטה תקספהב .אפורב ץעוויהל ילבמ ימואתפ ןפואב וז הפורת לוטיל קיספהל ןיא יוניש ,תוקזח בל תוקיפד ,הדרח ,טקש יא :ןוגכ ,הלימג ינמיס תעפוהמ ענמיהל תנמ לע וא/ו םדה ץחל ,בלה בצקב םי ,בג יבאכ ,םינושיא תבחרה ,םיקרפמו םירירש יבאכ ,)תלזנ ,עמד( רתי תושרפה ,העזה ,תורומרמצ ,דער ,המישנה .לושלש ,ןובאת ןדבוא ,האקה ,הליחב ,הניש ידודנ ,השלוח ,ןטבב תויוצווכתה

הכורכה הלועפ לכ ינפל וז הפורת תליטנ לע לפטמה אפורל חוודל ךילע

.ףוחד לופיט וא )םייניש ללוכ( חותינ ,המדרהב

.ןופליע םיינוציק םירקמבו תורוחרחס עונמל ידכ ,הדימעל הבישי/הביכש בצממ ימואתפ רבעממ ענמיהל שי

.הפורתל תרבגומה םתושיגר בקע ,םישישקב תשרדנ הבר תוריהז

םא התא לע עידוהל ךילע ,יהשלכ הפורתל וא והשלכ ןוזמל שיגר

ל אפורל ךכ .הפורתה תליטנ ינפ

ב לופיטה ינפל ןיטנוקיסקוא

אפורל רפס

םא לבוס התא :דוקפתב יוקילמ רבעב תלבס וא

המטסא ןוגכ( המישנה תכרעמ

גוס לכמ תטולב ,הרמה סיכ ,דבכה ,)ךומנ םד ץחל דחוימב( םדה ילכ וא/ו בלה ,) ,ןתשה תכרעמ/תוילכה ,לנרדאה תינומרעה תטולב

עב תלבס וא לבוס התא םא תויעבמ רב ( תיתקלד יעמ תלחמ וא תוריצע ,םייעמ חותינ ,ןוגכ לוכיעה תכרעמב

םא רבעב תלבס וא לבוס התא רבגומ יתלוגלוג ךות ץחל ,סירתה תטולב לש תוליעפ תת ,בלבלה תקלד ,תותיוועמ

האצותכ תוישפנ תויעב ,)םיפירח שאר יבאכב ראשה ןיב אטבתהל לוכיש( םיליער םירמוח תעפשהמ

toxic

psychosis

םימס וא תופורת ,לוהוכלאל תורכמתה ,)

תמ רבעב תלבס םא שומיש תקספה תובקעב( הלימג ינימס

:ןוגכ ,)םימסב וא תופורת יא

וא דער ,הדרח ,טקש .העזה

ךכ לע רפס ,הנוזת יפסותו םשרמ אלל תופורת ללוכ ,תורחא תופורת הנורחאל תחקל םא וא חקול התא םא חקורל וא אפורל

.

תואבה תופורתה תא חקול התא םא חקורה וא אפורה תא עדייל שי דחוימב

המישרה יכ ןייצל שי( אנא וללה תופורתהמ תחאב שמתשמ התא םאה חוטב ךניא םא .תופורתב םיליעפה םירמוחה תא תנייצמ ןלהלש

:)חקורה וא אפורה םע ץעיית

ופורת :ןוגכ( תיזכרמה םיבצעה תכרעמ לע תועיפשמה תופורת העגרהל ת

הנישל

םיניפזאידוזנב ללוכ ,הדרח תודגונ , .)תויטפלוריונ תופורת וא םיניזאיתונפ ןוגכ תוישפנ תוערפהב לופיטל תופורת

.ןואכיד דגנ תופורת

תופורת תיגרנילוכיטנא תוליעפ תולעב תופורת ,תונתשמ תופורת ,םירירש תייפרהל תופורת ,הובג םד ץחלב לופיטל

טל לשמל תושמשמ( )ןוסניקרפב לופי

.)לוזאנוקירוו ,לוזאנוקוטק :ןוגכ( תוירטפ דגנ תופורת

ה ףיגנ דגנ תופורת

)ריוונוטיר ןוגכ(

ןידיניווק

)בלב תויעבב לופיטל( ןידיטמיס ,

לוכיע תויעבב לופיטל הפורת(

ןוגכ

)תברצ ,הביק ביכ

.)היספליפאב לופיטל( ןיאוטינפ ,ןיפזמברק

ה תחפשממ הקיטויביטנא :ןוגכ( םידילורקמ

ןיציפמאפיר ,)ןיצימורתירלק ,ןיצימורתירא

)ןיפמאפיר(

ל תופורת המדרה

םירחא םידיאויפוא םיבאכ יככשמו ןוסקרטלנ

ןימאונומ יבכעמ תחפשממ תופורת

זאדיסקוא

(MAOIs)

.'םא הפורתב שמתשהל ןיא' ףיעס האר

הפורתב שומיש

ןוזמו

ל רשק אלל הפורתה תא לוטיל ןתינ .החוראה ינמז

:לוהוכלא תכירצו הפורתב שומיש

.וז הפורתב לופיטה תפוקתב לוהוכלא תותשל ןיא

יאוול תועפותל ןוכיסה תא ריבגהל וא ינונשי רתוי שיגרהל ךל םורגל הלולע הפורתב שומישה ןמזב לוהוכלא תייתש תורומח

.הרכהה דוביאו המישנ תקספהל ןוכיס םע המישנ יישק ןוגכ

ו ןוירה :הקנה

.הקינמ וא ןוירהב תא םא הפורתב שמתשהל ןיא

:תונוכמב שומישו הגיהנ

לכבו תונכוסמ תונוכמ תלעפהב ,בכרב הגיהנב תוריהז בייחמ ןכ לעו תונרעב םוגפל לולע וז הפורתב שומישה .תונרע תבייחמה תוליעפ

ו שיבכה תברקב םיקחשממ וא םיינפוא לע הביכרמ םריהזהל שי ,םידליל רשאב .המודכ

:םידליב שומיש

ליגל תחתמ םידליל תדעוימ הניא הפורתה

םיאליגב םירגבתמו םידליב שומישל עגונב אפורב ץעוויהל שי

6-18

.םינש

ןיטנוקיסקואב שמתשהל ןיא

םידליב

םירגבתמבו

ליגל תחתמ

:הפורתה לש םיביכרמהמ קלח לע בושח עדימ

וטקל הליכמ הפורתה תא םא .ז

אר( וז הפורת תליטנ ינפל אפורה תא עדיל שי ,זוטקלל שיגר

ףיעס

3

?הפורתב שמתשת דציכ .

.אפורה תוארוה יפל שמתשהל שי דימת

חוטב ךניא םא חקורה וא אפורה םע קודבל ךילע

לופיטה ןפואו ןונימה

אפורה ידי לע ועבקי דבלב

אוה ללכ ךרדב לבוקמה ןונימה

םיאתי אפורה ךל ןונימה תא םאתהב

ה תמצועלו ךבצמ באכ

.ךלש

( םיבוצק םינמזב הפורתה תא לוטיל שי ךרדב ללכ לכ

ש יפכ ,)תועש קיי לע עב

.לפטמה אפורה ידי .רתוי תופוכת םיתיעל וז הפורתב שמתשהל ןיא

תצלמומה הנמה לע רובעל ןיא

טמה אפורה םע תוצעייתה אלל ןונימה תא תונשל ןיא לפ

באכ שוחל ךישממ התא ,הפורתב לופיטה ךלהמב םא

הנפ .אפורל

.ץרפתמ באכ לש םיעוריא הווח ךניה םא לפטמה אפורל חוודל שי ןכ ומכ

,שותכל ,סועלל ןיא ,סימהל !הילבטה תא רובשל וא תוצחל

עולבל שי םימ סוכ םע תומלשב הילבטה תא

הגיפסה תרחא ל םורגלו רתוי הריהמ תויהל הלוכי

יאוול תועפו

רתי ןונימ ,ןוגכ תורומח

ףיעס האר(

.)'רתוי הובג ןונימ תועטב תלטנ םא'

.התעילבל שורדה ןמזל רבעמ הפב הילבטה תא קיזחהל ןיא

תאצל הלולע הילבטה לש הקירה תינבתהו ףוגב התוהש ךלהמב הילבטהמ הגרדהב ררחתשמ ליעפה רמוחה .)סגה יעמה חותינ רחאל ,תיקשב וא( האוצב גפסנ רבכ ליעפה רמוחהש רחאמ ,הגאד תררועמ הניא וז העפות .ףוגב

:בקעמו תוקידב

ךשמתמה ךרוצה תא ךירעהל תנמ לע ,תויתפוקת תוכרעה רובעל ךילע ,חווט ךורא לופיט ךלהמב הפורתב

םא תלטנ

רתוי הובג ןונימ תועטב

עלב תועטב םא וא תא הפורתה

רחא םדא לכ וא דלי

תונפל שי רל דימ אפו םילוח תיב לש ןוימ רדחל וא תא איבהלו .הפורתה תזירא רתי ןונימ ינימסת םייושע

תוליחב :לולכל תואקה/

,תורוחרחס ,םדה ץחלב הדירי ,ןושיאה תורציה ,תויזה ןכ ומכ .בר םונמנ םירומח םירקמב יישק עיפוהל םילולע .הרכה ןדבואל םורגל םילולעש המישנ

פר הרזע םישרוד הלא םינימסת .הפוחד תיאו

תחכש םא ה תא לוטיל :הפורת

ךות תרכזנו הדימב

ןמזהמ תועש

ייה וב

הפורתה תא תחקל רומא .ליגרה ןמזב חק האבה הנמה תא .דימ התוא חק ,

מ רתוי ורבע םא

,הפורתה תא תחקל רומא תייה וב ןמזהמ תועש

.אפורב ץעוויהל שי

לוטיל ןיא

הלופכ הנמ

שנש הנמה לע תוצפל ידכ החכ

.אפורה ידי לע ץלמוהש יפכ לופיטב דימתהל שי

חקורה וא אפורה םע תוצעייתה אלל הפורתב לופיטה קיספהל ןיא ,ךתואירב בצמב רופיש לח םא םג

קר זא םגו יתגרדה ןפואב

םא :הפורתה תליטנ תא קיספמ התא

ל קיספהל ןיא

ימואתפב הפורתה תא לוט

.תאז הרוה אפורה םא אלא ,ת התא םא יהל שי ,הפורתה תליטנ תא קיספהל הצור וו הווחת אלש ידכ תאז תושעל דציכ ךתוא החניש אפורב ץע ינימסת ןוגכ הלימג

,דער ,המישנה וא/ו םדה ץחל ,בלה בצקב םייוניש ,תוקזח בל תוקיפד ,הדרח ,טקש יא ,םינושיא תבחרה ,םיקרפמו םירירש יבאכ ,)תלזנ ,עמד( רתי תושרפה ,העזה ,תורומרמצ תויוצווכתה ,בג יבאכ ליחב ,הניש ידודנ ,השלוח ,ןטבב תו אקה , תו .לושלש ,ןובאת ןדבוא ,

הנמהו תיוותה קודב !ךשוחב תופורת לוטיל ןיא םעפ לכב

.םהל קוקז התא םא םייפקשמ בכרה .הפורת לטונ התאש

.חקורב וא אפורב ץעוויה ,הפורתב שומישל עגונב תופסונ תולאש ךל שי םא

4

תועפות .

יאוול

ןניא יאוולה תועפות םא .םישמתשמהמ קלחב יאוול תועפותל םורגל לולע ןיטנוקיסקואב שומישה ,הפורת לכב ומכ אלו ןכתי .יאוולה תועפות תמישר ארקמל להבית לא .אפורה םע ץעייתהל שי ,תורימחמ ןהש וא תודירטמ ןהש וא תופלוח .ןהמ תחא ףאמ לובסת

שי

דימ תונפל

אפורל

מ רדחל וא וי

ן

םילוח תיבב

תואבה יאוולה תועפות תועיפומ םא

:

תאטבתמה( תיטקליפנא וא תיגרלא הבוגת

המישנ יישק תוחיפנ ,

רוזאב

םינפה

הו ,)םיבחרנ םירוזאב דרגו החירפ ,ןורג ,םיסוכריפ יתמישנ יוכיד

ןטב יבאכ ,העונתב תוערפה ,קומע םונמנ ,ןורכיזב תוערפה ,לובלב ,השלחו תיטיא המישנ יקזח ץחלב הדירי ,םייעמ תמיסח ,ם

,תושבייתה ,ןתש תלטהב ישוק וא הנתשהב הדירי ,ריהמ בל בצק ,הרכה דוביא ,םד תורומרמצ וא תרבגומ העיז

נושיא .הבישח תוערפה ,תויזה ,םינטקומ םי

יאוול תועפות תובורק םיתיעל תועיפומה

תועיפומ

מ רתוי

ךותמ

:)םילפוטמ

לוכי אפורה( תוריצע ךל םושרל ,תואקה ,תוליחב ,לושלש ,ןטבב תוחונ רסוח וא ןטב יבאכ ,לוכיעב תויעב ,הפב שבוי ,)תלשלשמ הפורת ןדבוא ,ןובאית ,היסקרונא ,תונבצע ,םונמנ ,ןואכיד

,הדרח דער

,שאר באכ ,המישנ יישק ,המישנ רצוק ,םיפוצפיצ סקלפרב הדירי תרוחרחס ,לועישה

,השלוח וא הליגר אל תופייע ,הניש יישק ,לובלב וא/ו דוריג ,םיליגר אל תומולחו תובשחמ ,העזה יוריג וא החירפ ןוגכ רתי תושיגר לש תועפות

יאוול תועפות תוקוחר םיתיעל תועיפומה מ תוחפב תועיפומ(

ךותמ

)םילפוטמ

בצמב םייוניש

,חור תשגרה

ןופלע

,תרומרמצ

םיסוכריפ

יא ,םעטב םייוניש

ושיגר ,טקש ,הזחב םיבאכ ,באכל רתי ת ,םדה ץחלב הדירי ,תויזה תוקיפד תוליגר אל וא תוריהמ בל

,תושבייתה

,תמזגומ החמש תשוחת

,םישנב רוזחמ רדעה ,תונוא ןיא ,ינימה קשחב הדירי ,תוקצב ,אמצ ,הקמסה ,רועה תוימומדא

,תולדגומ הפמיל תוטולב

,םיילגרה תופכ וא םיילוסרקה ,םיידיה תוחפנתה רפה תוע

,היאר

,החונמ רסוח ,וגיטרו ,םיינזואב םילוצליצ ,תואצמתה רסוח וא רורקד ,עגמ וא באכל תויתשוחתב הדירי ,השוחת רסוח ,םוח ,רובידב תוערפה

,ןורכיזב תוערפה

,םיקוהיש ,העילב יישק ,םיזג ,םירירשה חתמ יונישו תויוצווכתה ,תינבצע הביק ןוגכ לוכיעה תכרעמב תויעב

כרדב תוערפה הרמה י

רועב דרגב אטבתהל תולוכיש(

ןתש ,רועה תבהצה ,)תרוויח האוצ ,ההכ

,הביקב תקלד ,ןתש תלטהב ישוק

,ןתש תריצא ,תששע

,םינושיאה לדוגב הדירי

,דבכ ימיזנאב הילע עטקמ( ג.ק.א תקידבב םייוניש ,ןרתנ תומרב הדירי

,רועה לש ףירח ףוליק ,רועב שבוי, )

,הירקיטרוא

חותיפ ליבס תו

תולת

,הפורתב

.הער תיללכ השוחת

:םידליב תויתפורת ןיב תובוגתו יאוול תועפות

יאוול תועפות ליעל האר .דליל תנתינה תפסונ הפורת לכ לעו יאוול תעפות לכ לע לפטמה אפורל חוודל םירוהה לע ןיב תובוגתו

.וטרופש תויתפורת

ולעב וניוצ אלש יאוול תועפות שיגרמ התא ובש הרקמ לכב ץעייתהל ךילע תיללכה ךתשגרהב יוניש לח םא וא ,הז ן דימ אפורה םע

5

?הפורתה תא ןסחאל ךיא .

ךכ ידי לעו תוקונית וא/ו םידלי לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכו וז הפורת !הלערה ענמ הלערה ענמת

.אפורהמ תשרופמ הארוה אלל האקהל םורגת לא

ז ךניא רשאכ ל דוע קוק תוילבט ה , .ןקוליס ןפוא לע חקורה םע ץעיית

( הגופתה ךיראת ירחא הפורתב שמתשהל ןיא

(exp. date

םויל סחייתמ הגופתה ךיראת .הזיראה יבג לע עיפומה .שדוח ותוא לש ןורחאה

ל תחתמ ןסחאל שי :ןוסחא יאנת

6

ףסונ עדימ

,ליעפה רמוחה לע ףסונ תוילבטה

ליכמ תו

תא םג

:םיאבה םיליעפ יתלבה םירמוחה

Lactose, stearyl alcohol, ammonio methacrylate copolymer, povidone, hypromellose, talc,

glyceryl triacetate, magnesium stearate, titanium dioxide, macrogol 400, brilliant blue (E133).

כ הליכמ הילבטה

.זוטקל ג"מ

תיארנ דציכ ?הזיראה ןכות המו הפורתה

עבצב תוילבט תלכת תזיראב ,

לש תוישגמ

.תוילבט

:ןרצי

.הילגנא ,לקיטיוצמראפ פאנ

:םושירה לעב

.ד.ת ,מ"עב אפר תודבעמ

םילשורי ,

91003

:תואירבה דרשמב יתכלממה תופורתה סקנפב הפורתה םושיר רפסמ

1317530830

בה דרשמ י"ע רשואו קדבנ הז ןולע ב תואיר רבוטקוא

2013

.םינימה ינשל תדעוימ הפורתה ךא ,רכז ןושלב חסונ הז ןולע האירקה תלקהו תוטשפה םשל

276005N

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