MIRTAZAPINE TEVA 30 MG

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s prescription only

Mirtazapine Teva

®

30 mg

Tablets

Composition:

Each tablet contains:

Mirtazapine 30 mg

For information about inactive and allergenic ingredients,

see section 2 - “Important information about some of

the ingredients of the medicine” and section 6 - “Further

Information”.

Read the leaflet carefully in its entirety before using

the medicine. This leaflet contains concise information

about the medicine. If you have further questions, refer to

the doctor or pharmacist.

This medicine has been prescribed to treat you. Do not

pass it on to others. It may harm them, even if it seems to

you that their medical condition is similar.

This medicine is not intended for use in children and

adolescents below

18 years of age

It will take 1-2 weeks until Mirtazapine Teva will start to

work. After 2-4 weeks you may start to feel better. If after

2-4 weeks you do not feel better or if you feel worse you

should speak with your doctor. Additional information

appears in section 3 under the heading “When can you

expect to start feeling better”.

Anti-depression and anti-anxiety medicines elevate

the risk of suicidal behavior and thoughts in children,

adolescents and young adults up to age 25.

When starting the treatment with the medicine, patients

of all ages and their relatives should monitor behavioral

changes, such as: worsening depression, suicidal

thoughts, aggression, and the like.

1.

WHAT IS THE MEDICINE INTENDED FOR?

Mirtazapine Teva is used to treat depression.

Therapeutic group: Preparation from the SNRI group.

2.

BEFORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive (allergic) to Mirtazapine or to any of

the additional ingredients contained in the medicine

(see section 6 - “Further Information”). If so, you must

talk to your doctor as soon as possible before beginning

to use Mirtazapine Teva.

You are taking or have recently taken (in the last two

weeks) medicines called monoamine oxidase inhibitors

(MAO-Is).

Special warnings regarding use of the medicine

Before beginning treatment with Mirtazapine Teva, talk with

your doctor or pharmacist.

Children and adolescents

Mirtazapine Teva is not intended for use in children and

adolescents under the age of 18 because efficacy has

not been demonstrated. Likewise, you should know that

for patients under the age of 18 who took medicines

from this group, there is an increased risk of side effects,

such as suicide attempt, suicidal thoughts and hostility

(mainly aggressiveness, oppositional behavior and anger).

If your doctor prescribed Mirtazapine Teva for a patient

under the age of 18 and you wish to discuss this, please

return to your doctor. You should inform the doctor if any

of the symptoms listed above develop or worsen while

patients under the age of 18 are taking Mirtazapine Teva.

Likewise, the long-term effects of Mirtazapine Teva in this

age group with regard to growth, sexual maturation, and

cognitive and behavioral development have not yet been

demonstrated. In addition, significant weight gain was

observed more frequently in this age group during treatment

with Mirtazapine Teva, in comparison with adults.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of

harming or killing yourself. These may be increased when

first starting antidepressants, since all these medicines

take time to start working, usually about two weeks, but

sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or

harming yourself

If you are a young adult. Information from clinical trials

has shown an increased risk of suicidal behavior in adults

aged less than 25 years with psychiatric conditions, who

were treated with antidepressants.

If you have thoughts of harming or killing yourself at any time,

contact your doctor or go straight to hospital.

You may find it helpful to share the fact that you are

depressed with a relative or close friend, and to ask them

to read this leaflet. You may ask them to tell you if they think

your depression is getting worse, or if they are worried about

changes in your behavior.

Likewise, be especially cautious with Mirtazapine Teva if:

You have or have ever had any of the following conditions

(tell you doctor about these condition before taking

Mirtazapine Teva, if you have not yet done so):

- Seizures (epilepsy). If you develop seizures or

your seizures become more frequent, stop taking

Mirtazapine Teva and contact your doctor immediately;

Liver disease, including jaundice. If jaundice develops,

stop taking Mirtazapine Teva and contact your doctor

immediately;

Kidney disease;

Heart disease, or low blood pressure;

Schizophrenia. If psychotic symptoms, such as

paranoid thoughts, become more frequent or severe,

contact your doctor immediately;

Manic depression (periods of feeling elated/over

activity alternating with periods of depressed mood).

If you start feeling elated or over-excited, stop taking

Mirtazapine Teva and contact your doctor immediately;

Diabetes (you may need to adjust your dose of insulin

or other antidiabetic medicines);

Eye disease, such as increased intraocular pressure

(glaucoma);

Difficulty in passing water (urinating), which could

be caused by an enlarged prostate;

Certain kinds of heart conditions that may change

your heart rhythm, a recent heart attack, heart failure,

or you take certain medicines that may affect the heart’s

rhythm.

You develop signs of infection, such as unexplained

high fever, sore throat and mouth ulcers. Stop taking

Mirtazapine Teva and consult with your doctor immediately

about a blood test.

In rare instances, these symptoms could be signs of

disturbances in blood cell production in the bone marrow.

Although they are rare, these symptoms most commonly

appear after 4-6 weeks of treatment.

You are an elderly person. You may be more sensitive to

the side effects of antidepressants.

Drug interactions

If you are taking, or have recently taken, other

medicines, including non-prescription medicines and

nutritional supplements, tell the doctor or pharmacist.

Do not take Mirtazapine Teva in combination with:

Monoamine oxidase inhibitors (MAO inhibitors).

Likewise, do not take Mirtazapine Teva during the first

two weeks after stopping treatment with MAO inhibitors.

If you stop taking Mirtazapine Teva, do not take MAO

inhibitors during the next two weeks either. Examples of

MAO inhibitors are moclobemide, tranylcypromine (both

of which are antidepressants) and selegiline (used for

Parkinson’s disease).

Be cautious when taking Mirtazapine Teva in

combination with:

Antidepressants, such as SSRIs, venlafaxine and

L-tryptophan or triptans (used to treat migraine),

tramadol (a pain-killer), linezolid (an antibiotic), lithium

(used to treat certain psychiatric conditions), methylene

blue (used to treat high levels of methemoglobin in the

blood) and St. John’s Wort - Hypericum perforatum

preparations (a herbal remedy for depression).

In very rare instances, taking Mirtazapine Teva alone or the

combination of Mirtazapine with these medicines could lead

to a condition called serotonin syndrome.

Some

symptoms

this

syndrome

are:

unexplained fever, sweating, increased heart rate,

diarrhea, (uncontrollable) muscle contractions, shivering,

overactive reflexes, restlessness, mood changes and

unconsciousness. If you have a combination of these

symptoms, talk to your doctor immediately.

The antidepressant nefazodone. It could increase the

amount of Mirtazapine in your blood. Inform your doctor

if you are using this medicine. It may be necessary to

decrease the dose of Mirtazapine, or to again increase

the dose of Mirtazapine after stopping treatment with

nefazodone.

Medicines for anxiety or insomnia such as

benzodiazepines,

Medicines for schizophrenia such as olanzapine,

Medicines for allergy such as cetirizine,

Medicines for severe pain such as morphine.

In combination with these medicines, Mirtazapine Teva

could increase the drowsiness caused by these medicines.

Medicines for infections. Medicines for bacterial

infections (such as erythromycin), medicines for treatment

of fungal infections (such as ketoconazole) and medicines

for HIV/AIDS (such as HIV-protease inhibitors),

Medicines for stomach ulcers (such as cimetidine).

In combination with Mirtazapine, these medicines could

increase the levels of Mirtazapine in your blood. Inform

your doctor if you are using these medicines. It may be

necessary to decrease the dose of Mirtazapine Teva, or

to again increase the dose of Mirtazapine Teva after these

medicines are stopped.

Medicines for epilepsy, such as carbamazepine and

phenytoin,

Medicines for tuberculosis such as rifampicin.

In combination with Mirtazapine, these medicines could

decrease the amount of Mirtazapine in your blood. Inform

your doctor if you are using these medicines. It may be

necessary to increase the dose of Mirtazapine Teva, or to

again decrease the dose of Mirtazapine Teva after these

medicines are stopped.

Medicines to prevent blood clotting such as warfarin.

Mirtazapine Teva could increase the effects of warfarin

on the blood. Inform your doctor if you are using this

medicine. In case of combination, it is recommended

that a doctor carefully monitor coagulation function.

Medicines that may affect the heart’s rhythm, such as

certain antibiotics and some antipsychotics.

Use of the medicine and food

The medicine can be taken with or without food.

Use of the medicine and alcohol consumption

You may be drowsy if you drink alcohol while taking

Mirtazapine Teva.

It is recommended not to drink any alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be

pregnant or planning a pregnancy, ask your doctor or

pharmacist for advice before taking this medicine.

Limited experience with administration of the medicine

to pregnant women does not indicate an increased risk.

Nevertheless, caution should be exercised when used

during pregnancy.

If you use Mirtazapine Teva until birth or until shortly before

birth, your baby should be monitored for possible side

effects.

When similar medicines (SSRIs) are taken during

pregnancy, they may increase the risk of a severe condition

in babies, called persistent pulmonary hypertension of the

newborn (PPHN), which causes the baby to breathe faster

and to appear bluish. These symptoms usually begin during

the first 24 hours after the baby’s birth. If this happens to

your baby, immediately contact your midwife and/or doctor.

Driving and operating machinery

Mirtazapine Teva can affect your concentration or alertness.

Make sure these abilities are not affected before you drive

or operate machinery.

Important information about some of the ingredients

of the medicine

Mirtazapine Teva tablets contain lactose. If you have been told

by your doctor that you have an intolerance to certain sugars,

contact your doctor before taking this medicinal product (see

also section 6 -

“Further Information”

3.

HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the doctor’s

instructions.

Check with the doctor or pharmacist if you are not sure

about the dosage and treatment regimen of the preparation.

The dosage and treatment regimen will be determined by

the doctor only. The usual dose is generally:

The usual starting dose is 15 or 30 mg every day. Your

doctor may advise you, after several days, which dose is

best for you (between 15 to 45 mg per day).

The dose is usually the same for all ages. However, if you

are an elderly person or if you have kidney disease or liver

disease, your doctor may adjust the dose.

Do not exceed the recommended dose.

How to use the medicine:

Take Mirtazapine Teva at the same time every day. It is

preferable to take the medicine as a single dose before

going to sleep. However, your doctor may advise you to

split the dose of the medicine – once in the morning and

once in the evening before going to sleep. The higher

dose should be taken before going to sleep.

Swallow the tablet with some water or juice.

The tablet can be halved at the score line.

There is no information regarding chewing, crushing or

pulverizing the tablet.

When can you expect to start feeling better

Usually, Mirtazapine Teva will start working after 1-2 weeks,

and after 2-4 weeks, you may start to feel better.

It is important that during the first weeks of treatment, you

talk with your doctor about the effects of Mirtazapine Teva:

2-4 weeks after starting treatment with Mirtazapine Teva, tell

your doctor how the medicine has affected you.

If you are still not feeling better, your doctor may prescribe a

higher dose for you. In this case, talk with your doctor again

after an additional 2-4 weeks.

Usually, you will need to continue taking Mirtazapine Teva

until the symptoms of your depression have gone away

for 4-6 months.

If you took more Mirtazapine Teva than you should have

If you or someone else took too much Mirtazapine, contact

a doctor immediately.

The most common signs of Mirtazapine overdose (without

other medicines or alcohol) are drowsiness, disorientation

and increased heart rate. The symptoms of a possible

overdose may include changes in your heart rhythm (fast,

irregular heartbeat) and/or fainting, which could be symptoms

of a life-threatening condition known as Torsade de Pointes.

If you took an overdose or if a child has accidentally

swallowed the medicine, proceed immediately to a hospital

emergency room, and bring the package of the medicine

with you.

If you forgot to take Mirtazapine Teva

If you are supposed to take your dose once a day

Do not take a double dose to compensate for the forgotten

dose. Take the next dose at the usual time.

If you are supposed to take your dose twice a day

If you forgot to take your morning dose, simply take it with

your evening dose.

If you forgot to take your evening dose, do not take it with

the next morning dose; just skip it and continue with your

normal morning and evening doses.

If you forgot to take both doses, do not attempt to make up

for the forgotten doses. Skip both doses and continue the

next day with your normal morning and evening doses.

Adhere to the treatment regimen as recommended by the

doctor.

If you stop taking Mirtazapine Teva

You should stop taking Mirtazapine Teva only after

consultation with your doctor.

If you stop too early, your depression might come back. As

soon as you feel better, talk with your doctor.

Your doctor will decide when the treatment can be stopped.

Do not suddenly stop taking Mirtazapine Teva, even if your

depression has disappeared. If you suddenly stop taking

Mirtazapine Teva, you could experience nausea, dizziness,

agitation or anxiety, and you may have headaches. These

symptoms can be prevented by stopping gradually. Your

doctor will tell you how to reduce the dose gradually.

How can you contribute to the success of the treatment?

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses

if you need them.

If you have further questions about the use of the

medicine, consult a doctor or pharmacist.

4.

SIDE EFFECTS

As with any medicine, use of Mirtazapine Teva may cause

side effects in some users. Do not be alarmed when reading

the list of side effects. You may not suffer from any of them.

If you experience any of the following serious side

effects, stop taking Mirtazapine and tell your doctor

immediately.

Uncommon side effects (occur in up to 1 in 100 users):

Feeling elated or emotionally “high” (mania).

Rare side effects (occur in up to 1 in 1,000 users):

Yellow coloring of the eyes or skin; this may suggest a

disturbance in liver function (jaundice).

Side effects of unknown frequency (frequency cannot

be estimated from the existing data):

Signs of infection, such as unexplained high fever,

sore throat and mouth ulcers (agranulocytosis). In

rare cases Mirtazapine can cause disturbances in the

production of blood cells (bone marrow depression).

Certain people could become less resistant to infection

because Mirtazapine can cause a temporary shortage of

white blood cells (granulocytopenia). In rare instances,

Mirtazapine can cause a temporary shortage of red and

white blood cells, as well as platelets (aplastic anemia),

platelet deficiency (thrombocytopenia) or an increased

number of white blood cells (eosinophilia).

Epileptic attack (convulsions)

A combination of symptoms, such as unexplained fever,

sweating, increased heart rate, diarrhea, (uncontrollable)

muscle contractions, shivering, overactive reflexes,

restlessness, mood changes, unconsciousness and

increased salivation. In very rare cases, these can be

signs of serotonin syndrome

Thoughts of harming or killing yourself

Severe skin reactions (Stevens-Johnson syndrome, toxic

epidermal necrolysis)

Additional side effects:

Very common side effects (occur in more than 1 in

10 users):

Increased appetite and weight gain

Drowsiness or sleepiness

Headache

Dry mouth

Common side effects (occur in up to 1 in 10 users):

Lethargy

Dizziness

Instability or tremor

Nausea

Diarrhea

Vomiting

Constipation

Rash or skin eruptions (exanthema)

Joint pain (arthralgia) or muscle pain (myalgia)

Back pain

Feeling dizzy or faint when you stand up suddenly

(orthostatic hypotension)

Swelling (typically in ankles or feet) caused by fluid

retention (edema)

Tiredness

Vivid dreams

Confusion

Feeling anxious

Sleeping problems

Uncommon side effects (occur in up to 1 in 100 users):

Abnormal sensations in the skin, such as burning,

stinging, tickling or tingling (paresthesia)

Restless legs

Fainting (syncope)

Numbness in the mouth (oral hypoesthesia)

Low blood pressure

Nightmares

Feeling agitated

Hallucinations

Urge to move

Rare side effects (occur in up to 1 user in 1,000):

Muscle twitching or contractions (myoclonus)

Aggressiveness

Abdominal pain and nausea; this may suggest

inflammation of the pancreas (pancreatitis)

Side effects of unknown frequency (frequency cannot

be estimated from the existing data):

Abnormal sensations in the mouth (oral paresthesia)

Swelling in the mouth (mouth edema)

Swelling in the body (generalized edema)

Localized swelling

Low blood sodium (hyponatremia)

Inappropriate anti-diuretic hormone secretion

Severe skin reactions (dermatitis bullous, erythema

multiforme)

Sleep walking (somnambulism)

Speech disorder

Increased levels of creatine kinase in the blood

Difficulty in passing urine (urinary retention)

Muscle pain, stiffness and/or weakness, darkening or

discoloration of the color of the urine (rhabdomyolysis)

Additional side effects in children and adolescents:

In children under 18 years of age, the following side effects

were observed commonly in clinical trials:

Significant weight gain

Hives (an allergic reaction in the skin)

Increased blood triglycerides.

If a side effect occurs, if one of the side effects worsens

or if you suffer from a side effect not mentioned in the

leaflet, consult with the doctor.

Reporting side effects

Side effects can be reported to the Ministry of Health by

clicking on the link “Report Side Effects of Drug Treatment”

found on the Ministry of Health homepage (www.health.gov.il)

that directs you to the online form for reporting side effects,

or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

5.

HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine, and any other medicine,

should be kept in a safe place out of the reach and sight

of children and/or infants in order to avoid poisoning. Do

not induce vomiting unless explicitly instructed to do so

by a doctor.

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

that appears on the package. The expiry date refers to

the last day of that month.

Store below 25

Protect from light and moisture.

Do not dispose of medicines via wastewater or household

waste bin. Ask the pharmacist how to dispose of

medicines that are no longer in use. These measures

will help protect the environment.

6.

FURTHER INFORMATION

In addition to the active ingredient, the medicine also

contains:

Lactose monohydrate, lactose spray dried, starch,

povidone, hypromellose, magnesium stearate, polyethylene

glycol, titanium dioxide, colloidal silicon dioxide, iron oxide

yellow, iron oxide red

Each tablet contains approximately 226.66 mg of lactose

What the medicine looks like and the contents of the

package:

A round, red-brown tablet, with a score line on one side of

the tablet, with the number “9” debossed on one side of it

and the number “3” debossed on the other side. The number

“7207” debossed on the other side of the tablet.

The package contains 10 tablets or 30 tablets.

Not all package sizes may be marketed.

Name of Manufacturer and License Holder and its Address:

Teva Pharmaceutical Industries Ltd., P.O.B. 3190,

Petach Tikva.

This leaflet was checked and approved by the Ministry of

Health in June 2015, and was updated in accordance with

the Ministry of Health Guidelines in July 2018

Registration number of the medicine in the National

Drug Registry of the Ministry of Health:

Mirtazapine Teva 30 mg: 128.60.30665

MIRT TAB PL SH 251018

MIRT TAB PL SH 251018

لضفأ لكشب كروعش ءدب عقوت كنكمي ىتم ﻦم عيباسأ 4-2 دعبو عيباسأ 2-1 دعب ريثأتلاب عڤيت ﻦيﭘازاتريم أدبي ،ةداع .لضفأ لكشب روعشلاب أدبت نأ كنأش صوصخب ،جلاعلا ﻦم ىلولأا عيباسلأا للاخ كبيبط عم ثدحتت نأ مهملا ﻦم :عڤيت ﻦيﭘازاتريم تاريثأت .ءاودلا كيلع رثأ فيك كبيبطل كحإ ،عڤيت ﻦيﭘازاتريم ـب جلاعلا ءدب دعب عيباسأ 4-2 ةعرج كل فصي نأ كبيبط نأش ﻦمف ،نلآا ىتح لضفأ لكشب رعشت مل اذإ .ةيفاضإ عيباسأ 4-2 دعب ةيناث كبيبط عم ثدحت ةلاحلا هذه يف .ربكأ ةيئاود بائتكلإا ضارعأ لاوز ىتح عڤيت ﻦيﭘازاتريم لوانت ةلصاوم كيلع بجوتي ،ةداع .رهشأ 6-4 ةدمل كيدل هتجاحب تنأ امم رثكأ عڤيت ﻦيﭘازاتريم ﻦم تلوانت اذإ كبيبطب لصتإف ،ﻦيﭘازاتريم ﻦم يغبني امم رثكأ رخآ صخش وأ تنأ تلوانت اذإ

اروف ةيودأ نودب( ﻦيﭘازاتريم ﻦم ةيئاودلا ةعرجلا طرفل

اعويش رثكلأا تاملاعلا ةعرجلا طرف ضارعأ .بلقلا مظن ديازتو ناهوت ،ساعن يه )لوحك وأ ةيفاضإ ،عيرس( كيدل بلقلا مظن يف تاريغت لمشت نأ اهنأش ﻦم ةلمتحملا ةيئاودلا ىلع

ارطخ لكشت ةلاحل

اضارعأ نوكت دق يتلا ءامغإ وأ/و )مظتنم ريغ ضبن

Torsade de Pointes

( تناوﭘ يد داسروت مسإب فرعت يتلا ةايحلا

لااح هجوت ،ءاودلا ﻦم أطخلاب لفط علب اذإ وأ ةطرفم ةيئاود ةعرج تلوانت اذإ .كعم ءاودلا ةبلع رضحأو ،ىفشتسملا يف ئراوطلا ةفرغل عڤيت ﻦيﭘازاتريم لوانت تيسن اذإ مويلا يف ةرم ةيئاودلا كتعرج لوانت كيلع ضرتفملا ﻦم ناك اذإ .ةيسنملا ةيئاودلا ةعرجلا ﻦع ضيوعتلل ةفعاضم ةيئاود ةعرج لوانت زوجي لا .يدايتعلإا تقولا يف ةيلاتلا ةيئاودلا ةعرجلا لوانت بجي مويلا يف ﻦيترم ةيئاودلا كتعرج لوانت كيلع ضرتفملا ﻦم ناك اذإ اهلوانت ةطاسبب ،حابصلا يف كب ةصاخلا ةيئاودلا ةعرجلا لوانت تيسن اذإ

.كب ةصاخلا ةيئاسملا ةيئاودلا ةعرجلا عم ةعرج عم اهلوانت زوجي لاف ،ةيئاسملا ةيئاودلا كتعرج لوانت تيسن اذإ

ةيحابصلا ءاودلا تاعرج لامعتسإب لصاوو اهت

وف ةطاسبب ،يلاتلا حابصلا .كب ةصاخلا ةيدايتعلإا ةيئاسملاو تاعرجلا ﻦع ضيوعتلا لواحت لاف ،ﻦيتيئاودلا ﻦيتعرجلا لوانت تيسن اذإ

لامعتسإب يلاتلا مويلا يف لصاوو ﻦيتيئاودلا ﻦيتعرجلا ت

وف .ةيسنملا ةيئاودلا .كب ةصاخلا ةيدايتعلإا ءاسملاو حابصلا تاعرج .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي عڤيت ﻦيﭘازاتريم لوانت ﻦع تفقوت اذإ .كبيبط ةراشتسإ دعب طقف عڤيت ﻦيﭘازاتريم لوانت ﻦع فقوتلا ناكملإاب ةظحل يف .كيدل بائتكلإا دوعي دقف ،يغبني امم رثكأ ركبم لكشب تفقوت اذإ .كبيبط عم ثدحت ،لضفأ لكشب كروعش .جلاعلا ﻦع فقوتلا كنكمي ىتم كبيبط ررقي بائتكلإا لاز ولو ىتح ،ئجافم لكشب عڤيت ﻦيﭘازاتريم لوانت ﻦع فقوتت لا رعشت دق تنأف ئجافم لكشب عڤيت ﻦيﭘازاتريم لوانت ﻦع تفقوت اذإ .كب صاخلا بنجت ناكملإاب .عادص كيدل ث دحي نأ ﻦكميو ،قلقب وأ جايتهإب ،راود ،نايثغب فيك كبيبط كربخي .يجيردت لكشب فقوتلا قيرط ﻦع ضارعلأا هذه ثودح .جيردتلاب ةيئاودلا ةعرجلا للقت ؟جلاعلا حاجن يف ةمهاسملا كنكمي فيك دكأتلاو ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف ةيئاودلا ةعرجلا ﻦم .كلذ رملأا مزل اذإ ةيبطلا بيبطلا رشتسإ ،ءاودلا اذه لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ ةيبناجلا ضارعلأا )4 ضعب دنع ةيبناج

اضارعأ ببسي دق عڤيت ﻦيﭘازاتريم لامعتسإ نإ ،ءاود لكب امك .اهنم

ايأ يناعت لاأ زئاجلا ﻦم .ةيبناجلا ضارعلأا ةمئاق ﻦم شهدنت لا .ﻦيلمعتسملا فقوتف ،ةيلاتلا ةيدجلا ةيبناجلا ضارعلأا ﻦم لك ﻦم يساقت تنك اذإ

.

ً

لااح كبيبطل كحإو ﻦيﭘازاتريم لوانت ﻦع :)لمعتسم 100 ﻦيب ﻦم 1 ىتح ىدل رهظت( ةعئاش ريغ ةيبناج ضارعأ .)سوه( يفطاع »ءاشتنإب« وأ ةيلاع تايونعمب روعشلا

:)لمعتسم 1000 ﻦيب ﻦم 1 ىتح ىدل رهظت( ةردان ةيبناج ضارعأ بارطضإ ثودح ىلإ ريشي نأ هنأش ﻦم يذلا رملأا ،دلجلا وأ ﻦينيعلا رارفصإ

.)ناقري( يدبكلا يفيظولا ءادلأا يف ﻦم عويشلا مييقت ﻦكمي لا( فورعم ريغ عويشب ةيبناج ضارعأ :)ةرفوتملا تامولعملا ةرجنحلا يف ملأ ،ببسلا ةلوهجم ةعفترم ةنوخس لثم ،ثولتل تاملاع ﻦيﭘازاتريم ،ةردان تلااح يف .)

agranulocytosis

( مفلا يف تاحرقتو ضعب .)مظعلا خم طيبثت( مد ايلاخ جاتنإ يف تابارطضإ ببسي دق نأ ﻦكمي ﻦيﭘازاتريم نلأ

ارظن ثولتلل ةمواقم لقأ اونوكي دق صاخشلأا يف .)

granulocytopenia

( ءاضيبلا مدلا ايلاخ يف تقؤم صقنل يدؤي ءارمحلا مدلا ايلاخ يف تقؤم صقنل يدؤي دق ﻦيﭘازاتريم ،ةردان تلااح يف صقن ،)يجسنت لا مد رقف( ةيومدلا تاحيفصلل ةفاضلإاب ،ءاضيبلاو ايلاخ دادعت يف عافترإ وأ )

thrombocytopenia

( ةيومدلا تاحيفصلا

eosinophilia

( ءاضيبلا مدلا .)تاصلقت( ةيعرص ةبون مظن يف ةدايز ،قرعت ،ببسلا ةلوهجم ةنوخس لثم ،ضارعلأا ﻦم جيزم ثودح ،فاجترإ ،)ةرطيسلا ﻦع ةجراخ( ةيلضع تاصلقت ،لاهسإ ،بلقلا نادقف ،جازملا يف تاريغت ،ءودهلا ةلق ،دحلا ﻦع طرفم لكشب تاسكعنم هذه نوكت نأ ﻦكمي ،

ادج ةردان تلااح يف .باعلل دئاز نلايسو يعولا ﻦينوتوريسلا ةمزلاتمل تاملاع كسفن لتقل وأ كسفن ةيذلأ راكفأ

ةرشبلا للاحنإ ،نوسنوج ـ سنڤيتس ةمزلاتم( ةريطخ ةيدلج لعف دودر )يمسلا يرخنلا :ةيفاضإ ةيبناج ضارعأ :)ﻦيلمعتسم 10 ﻦيب ﻦم 1 ﻦم رثكأ ىدل رهظت(

ً

ادج ةعئاش ةيبناج ضارعأ نزولا ةدايزو ماعطلل ةيهشلا ةدايز مونلل ليم وأ ساعن عادص مفلا يف فافج :)ﻦيلمعتسم 10 ﻦيب ﻦم 1 ىتح ىدل رهظت( ةعئاش ةيبناج ضارعأ

Lethargy

( ماو

ن راود فاجترإ وأ تابثلا مدع نايثغ لاهسإ

ؤيقت كاسمإ

exanthema

( يدلج حفط وأ حفط

myalgia

( ةيلضع ملاآ وأ )

arthralgia

( لصافملا يف ملاآ

رهظلا يف ملأ

ضافخنإ( ئجافم لكشب فوقولا ةيعضول لاقتنلإا دنع ءامغإ وأ راودب روعشلا

)يباصتنلإا مدلا طغض لئاوسلا سابتحإ ﻦع جتانلا )ﻦيمدقلا يتحار يف وأ ﻦيلحاكلا يف ةداع( خافتنإ

)ةمذو( قاهرإ

ةيقيقح ملاحأ

كابترإ

قلقب روعشلا

مونلا يف لكاشم :)لمعتسم 100 ﻦيب ﻦم 1 ىتح ىدل رهظت( ةعئاش ريغ ةيبناج ضارعأ

paresthesia

( لمنت وأ ةغدغد ،زخو ،قرح لثم ،دلجلا يف ةذاش سيساحأ

ﻦيقاسلا لملمت

syncope

( ءامغإ

)مفلا يف سحلا صقن( مفلا يف ناردخ مدلا طغض ضافخنإ

سيباوك ناجيهب روعشلا

نايذه ةكرحلا يف ةبغرلا

:)لمعتسم 1000 ﻦيب ﻦم 1 ىتح ىدل رهظت( ةردان ةيبناج ضارعأ

myoclonus

( ةيلضع تاصلقت وأ تاجنشت ةيناودع سايركنبلا باهتلإ ىلع لدي دق يذلا رملأا ،نايثغو ﻦطبلا يف ملأ

pancreatitis

ﻦم عويشلا مييقت ﻦكمي لا( فورعم ريغ اهعويش ةيبناج ضارعأ :)ةرفوتملا تامولعملا )مفلا يف لمنت( مفلا يف ةذاش سيساحأ

)مفلا يف ةمذو( مفلا يف خافتنإ

)ةماع ةمذو( مسجلا يف خافتنإ

يعضوم خافتنإ

hyponatremia

( مدلا يف مويدوصلا صقن

anti-diuretic

( لوبلا راردلإ داضملا نومروهلل ميلس ريغ زارفإ

)لاكشلأا ةددعتم ىمامح ،يلصيوحلا دلجلا باهتلإ( ةديدش ةيدلج لعف دودر

somnambulism

( مونلا للاخ يشملا

قطنلا يف بارطضإ

مدلا يف زانيك ﻦيتايركلا بسن يف عافترإ

)لوبلا سابتحإ( لوبتلا يف ةبوعص لوبلا نوــل ناتهب وأ ةناكد ،فعض وأ/و بلصت ،ةيلضع ملاآ

rhabdomyolysis

:ﻦيقهارملاو لافطلأا ىدل ةيفاضإ ةيبناج ضارعأ ىدل ،ةيريرسلا ثاحبلأا يف عئاش لكشب ةيلاتلا ةيبناجلا ضارعلأا تظحول :ةنس 18 رمع نود لافطأ نزولا يف ةظوحلم ةدايز )يدلج يسسحت لعف در( ىرش .مدلا يف تاديريسيلچيرتلا عافترإ

امدنع وأ ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةرشنلا هذه يف ركذي مل يبناج ضرع ﻦم يناعت ةيبناج ضارعأ ﻦع غيلبتلا ىلع طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ ﻦع غيلبتلا ناكملإاب ةحفصلا ىلع دوجوملا »يئاود جلاع بقع ةيبناج ضارعأ ﻦع غيلبت« طبارلا ىلإ كهجوي يذلا )

www.health.gov.il

( ةحصلا ةرازو عقومل ةيسيئرلا :طبارلا حفصت قيرط ﻦع وأ ،ةيبناج ضارعأ ﻦع غيلبتلل رشابملا جذومنلا

https://forms.gov.il/globaldata/getsequence/getseque

nce.aspx?formType=AdversEffectMedic@moh.gov.il

؟ءاودلا ﻦيزخت ةيفيك )5

اديعب قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي ! ممستلا بنجت مهتباصإ

يدافتل كلذو

،عضرلا وأ/و لافطلأا ةيؤر لاجمو يديأ لوانتم ﻦع .بيبطلا ﻦم ةحضاو تاميلعت نودب ؤيقتلا ببست لا . ممستلاب يذلا )

exp. date

( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا ﻦم ريخلأا مويلا ىلا ةيحلاصلا ءاهتنإ خيرات ريشي .ةبلعلا رهظ ىلع رهظي .رهشلا سفن .ةيوئم ةجرد 25 ﻦع لقت ةرارح ةجردب ﻦيزختلا بجي .ةبوطرلاو ءوضلا ﻦم ةيامحلا بجي يلديصلا لأسإ .ةيلزنملا ةمامقلا يف وأ يراجملا يف ةيودلأا يمر زوجي لا دعاست لئاسولا هذه .لامعتسلإا ديق دعت مل ةيودأ ﻦم صلختلا ةيفيك ﻦع .ةئيبلا ىلع ظافحلا يف ةيفاضإ تامولعم )6

:

ً

اضيأ لاعفلا بكرملل ةفاضلإاب ءاودلا يوتحي

Lactose monohydrate, lactose spray dried, starch,

povidone, hypromellose, magnesium stearate,

polyethylene glycol, titanium dioxide, colloidal silicon

dioxide, iron oxide yellow, iron oxide red

زوتكل غلم 226٫66 يلاوح ىلع صرق لك يوتحي :ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك رطشلل طخ دجوي صرقلل دحاو بناج ﻦم ،ينب ـ رمحأ نولب ريدتسم صرق يف عبط .»

« ددعلا عبط يناثلا هفرط ﻦمو »

« ددعلا عبط لولأا هفرط ﻦم

7207

« ددعلا صرقلل يناثلا بناجلا

اصرق 30 وأ صارقأ 10 ىلع ةبلعلا يوتحت .بلعلا ماجحأ ةفاك قوست لاأ زئاجلا ﻦم تارضحتسملاو ةيودلأل عڤيت :هناونعو زايتملإا بحاصو جتنملا مسإ .اڤكت ـ حتيﭘ ،3190 .ب.ص ،.ض.م ةيبطلا ناريزح يف صخ

رو صح

ف اهاوتحمو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ 2018 زومت خيراتب ةحصلا ةرازو تاميلعت بجومب اهثيدحت متو 2015 :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر 128-60-30665 :غلم 30 عڤيت ﻦيﭘازاتريم ىلع .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا ﻦيوهتو ةلوهس لجأ ﻦم .ﻦيسنجلا لاكل صصخم ءاودلا نإف ،كلذ ﻦم مغرلا ةمتت