TOPIRAMATE TEVA 400 MG

Israel - English - Ministry of Health

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Active ingredient:
TOPIRAMATE
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N03AX11
Pharmaceutical form:
TABLETS
Composition:
TOPIRAMATE 400 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
TOPIRAMATE
Therapeutic area:
TOPIRAMATE
Therapeutic indications:
Topiramate Teva is indicated as adjunctive therapy for adults and children aged 6 and above with partial onset seizures or generalized tonic-clonic seizures. Topiramate teva is also indicated in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome . Topiramate Teva is indicated as monotherapy in patients with newly diagnosed epilepsy in adults and children aged 7 years and above or for conversion to monotherapy in patients with epilepsy.
Authorization number:
135 20 31256 01
Authorization date:
2011-08-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

06-06-2019

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

The name of the preparation and its form:

TOPIRAMATE TEVA 25 mg

Tablets

Active ingredient and its quantity

Each tablet contains:

Topiramate 25 mg

TOPIRAMATE TEVA 50 mg

Tablets

Active ingredient and its quantity

Each tablet contains:

Topiramate 50 mg

TOPIRAMATE TEVA 100 mg

Tablets

Active ingredient and its quantity

Each tablet contains:

Topiramate 100 mg

TOPIRAMATE TEVA 200 mg

Tablets

Active ingredient and its quantity

Each tablet contains:

Topiramate 200 mg

For information on inactive and allergenic

ingredients, see section 2 – “Important

information about some of the ingredients of the

medicine” and section 6 – “Further information”.

Read this 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 the 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 infants and

children under two years of age and as a

monotherapy under 7 years of age.

1. WHAT IS THE MEDICINE INTENDED

fOR?

The medicine is intended for:

Treatment of seizures. For use in combination

with other medicines in adults and children

from the age of 2 years and up or as a

monotherapy in adult patients and children

from the age of 7 years and up.

Prevention of migraines in adults. The

preparation is not intended for pain relief

during a migraine attack.

Therapeutic group: anti-epileptic medicines

2. BEfORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive (allergic) to the active

ingredient or to any of the additional

ingredients contained in the medicine, as

detailed in section 6 – “Further information”.

You are taking the medicine to prevent

migraine and you are pregnant or think you

are pregnant or you are of child-bearing age

and are not using effective contraceptives.

Special warnings regarding use of the

medicine:

Do not use the medicine without consulting

a doctor before starting treatment if you

suffer from:

impaired function of the kidney, kidney

problems, especially kidney stones, or you

are a patient undergoing dialysis

a history of problems relating to blood and

body fluids (metabolic acidosis)

liver problems

eye problems (especially if you have

glaucoma)

growth problems

if you are on a ketogenic diet (a low-

carbohydrate and high-fat diet)

you are pregnant or may become pregnant

(see “Pregnancy and breastfeeding” section

for further information)

If any of the conditions above apply to you, talk

to the doctor before using the medicine.

It is important that you do not stop taking the

medicine without first consulting the doctor.

Do not take any other medicine that contains

topiramate, given to you as a substitute for this

medicine, without first consulting the doctor.

You may lose weight when using Topiramate

Teva. Weigh yourself regularly during

treatment with Topiramate Teva. If you lose

a lot of weight, or if a child being treated

with Topiramate Teva does not gain enough

weight, consult a doctor.

In a small number of patients treated with

antiepileptics, such as Topiramate Teva,

suicidal thoughts or suicidal behavior have

been reported. In case suicidal thoughts

occur, refer to the doctor immediately!

Pay attention to any change in mood,

behavior, thoughts and emotions, especially

to sudden changes. Refer to a doctor

immediately if you are suffering from any

of the following symptoms, especially if it is

new, worsens or worries you: suicide attempt,

depression/anxiety/irritability that is new or

has worsened, a feeling of restlessness,

panic attack, sleeping difficulties (insomnia),

aggressive

behavior,

anger,

violence,

dangerous impulsive behavior, a sharp rise

in activeness and thought (mania), other

abnormal changes in thoughts or mood.

Topiramate Teva may cause eye problems.

Severe eye problems include reduced

vision, with or without pain and redness in

the eye, blockage of fluids in the eye causing

intraocular pressure (glaucoma). These

problems may lead to permanent vision loss,

if left untreated. Inform the doctor immediately

of any new symptom in the eyes and, in

particular, of new vision problems.

Topiramate Teva may cause decreased

sweating and increased body temperature

(fever). Monitor symptoms of reduced

sweating and fever, especially in children

and in hot weather. Medical attention may be

necessary. Refer to a doctor immediately if

you have high fever, fever that does not go

down or decreased sweating.

Topiramate Teva may increase the acid

levels in the blood (metabolic acidosis).

If left untreated, metabolic acidosis may

lead to brittle or soft bones, kidney stones,

slowed growth rate in children, and if you

are pregnant, may harm the fetus. Metabolic

acidosis can be with or without symptoms. You

may experience tiredness, loss of appetite,

changes in heart rate, difficulty in thinking

clearly. The doctor must perform blood tests

to check acid levels in your blood, before

and during the course of treatment. If you

are pregnant, speak to the doctor if you are

suffering from metabolic acidosis.

Drug interactions

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements, tell

the doctor or the pharmacist.

In particular, inform the doctor or the pharmacist

if you are taking:

Other medicines that affect or decrease your

level of thinking, concentration or muscle

coordination (e.g., central nervous system

depressants such as muscle relaxants and

sedatives and hypnotics).

Birth control pills. Topiramate Teva can impair

the effectiveness of birth control pills. Tell the

doctor if you experience changes in your

menstrual cycle while using contraceptives

and Topiramate Teva.

Other antiepileptics.

Risperidone (for treatment of schizophrenia).

Lithium (for treatment of manic depression).

Hydrochlorothiazide, propranolol, diltiazem

(for treatment of heart problems and to lower

blood pressure).

Metformin, pioglitazone, glyburide (for

treatment of diabetes).

Amitriptyline, venlafaxine (for treatment of

depression).

Flunarizine (to prevent migraines and to treat

vertigo).

Hypericum perforatum (St. John’s wort, a

herbal medicine to treat depression).

Use of the medicine and food

Topiramate Teva can be taken with or after food

or between meals.

Be sure to drink lots of fluids during the course

of treatment (to reduce the risk of formation of

kidney stones).

Do not go on a ketogenic diet (a low-

carbohydrate and high-fat diet) during the

course of treatment with Topiramate Teva.

Use

of

the

medicine

and

alcohol

consumption

Avoid drinking alcohol during the course of

treatment with the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think

you may be pregnant or are planning to

become pregnant, consult the doctor before

commencing treatment. The doctor will talk

to you about using contraceptives, as well as

whether Topiramate Teva is suitable for you. As

with other antiepileptics, there is a chance of

harm to the fetus if Topiramate Teva is taken

during pregnancy.

Consult the doctor regarding the risks and

benefits of using Topiramate Teva to treat

epilepsy during pregnancy.

If you are pregnant, think you are pregnant

or are of child-bearing age and you are not

using effective contraceptives, do not use the

medicine to prevent migraine.

If you are breastfeeding and being treated with

Topiramate Teva, inform the doctor immediately

of any unusual effects in your baby.

Driving and operating machinery

Use of the medicine may cause dizziness,

tiredness and visual problems. Do not drive

or operate dangerous machinery before first

talking with the doctor. Children should be

cautioned against riding a bicycle or playing

near the road, and the like.

Important information about some of the

ingredients of the medicine

Topiramate Teva tablets contain lactose.

If you suffer from intolerance to certain sugars,

consult the doctor before using the medicine.

See section 6 – “Further information” for details

on the amount of lactose per tablet.

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 uncertain regarding

the dosage and treatment regimen of the

preparation.

The dosage and treatment regimen will be

determined by the doctor only.

The doctor will usually start with a low dosage

of Topiramate Teva and will gradually increase

the dosage until the dosage suitable for you is

found.

Do not exceed the recommended dose.

Swallow Topiramate Teva tablets whole, with

a lot of water.

For small children and children having a hard

time swallowing - crush the tablet.

Topiramate Teva 25 mg: Do not halve the tablet,

do not chew, since the tablet may leave a bitter

taste.

If necessary, to ease swallowing, you can

crush the tablet or divide it into smaller parts,

but swallow all the parts of the tablet at the

same time.

Topiramate Teva 50 mg, 100 mg, 200 mg: The

tablets can be halved on the score line. The

tablet can be crushed, do not chew, as the tablet

may leave a bitter taste.

Topiramate Teva can be taken with or after food

or between meals.

Be sure to drink a lot during the course of

treatment to prevent formation of kidney stones.

If you accidentally took a higher dosage

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. Do

not induce vomiting unless explicitly instructed

to do so by the doctor!

If you took an overdose, you may feel

sleepy, tired or less alert, experience lack of

coordination, difficulty speaking or difficulty

concentrating, double vision or blurred vision,

feel depressed or nervous, abdominal pain,

seizures or dizziness due to low blood pressure.

Overdose can occur when you take other

medicines together with Topiramate Teva.

If you forgot to take this medicine at the required

time, take a dose as soon as you remember, but

if you remember close to the time for taking the

next dose, skip the forgotten dose and continue

as usual. Never take two doses together!

If you forgot two or more doses, contact the

doctor.

Adhere

treatment

regimen

recommended by the doctor.

Even if there is an improvement in your health,

do not stop treatment without consulting the

doctor, as the symptoms may return. If the

doctor decides to stop treatment, the dosage

will be gradually lowered over several days.

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 regarding use

of the medicine, consult the doctor or the

pharmacist.

4. SIDE EffECTS

As with any medicine, use of Topiramate Teva

may cause side effects in some users. Do not

be alarmed by the list of side effects. You may

not suffer from any of them.

Effects which require special attention:

Refer to the doctor immediately if you notice

any of the following effects:

Very common side effects - effects that occur

in more than one user in ten:

Depression (new onset or worse than previous

status).

Common side effects - effects that occur in

up to 1 in 10 users:

Seizures, anxiety, nervousness, mood changes,

confusion, disorientation, concentration

disturbances, slowed thinking, loss of memory,

memory problems (new onset, sudden change

or deterioration), kidney stones, frequent or

painful urination.

Uncommon side effects - effects that occur

in up to 1 in 100 users:

Increased acid level in the blood (may cause

breathing problems including shortness of

breath, loss of appetite, nausea, vomiting,

excessive tiredness and fast or uneven

heartbeats), decreased or termination of

sweating (especially in young children exposed

to high temperatures), thoughts and attempts of

serious self-harm, loss of part of the visual field.

Rare side effects - effects that occur in up

to 1 in 1,000 users:

Glaucoma (blockage of fluid in the eye,

causing increased intraocular pressure, pain

or decreased vision).

Other side effects, of which the doctor

should be informed if they worsen:

Very common side effects - effects which

occur in more than one user in ten:

Nasal congestion, runny nose, sore throat

Tingling, pain and/or numbness of various

body parts

Tiredness or sleepiness

Dizziness

Diarrhea

Nausea

Weight loss

Common side effects - effects that occur in

up to 1 in 10 users:

Anemia (low blood count)

Allergic reaction (such as skin rash, redness,

itching, facial swelling, hives)

Decreased appetite or loss of appetite

Aggression, anxiety, anger, abnormal

behavior

Difficulty falling or staying asleep

Problems with speech, slurred speech

Clumsiness or lack of coordination, feeling of

unsteadiness when walking

Decreased ability to complete routine tasks

Decrease/change/absence of sense of taste

Involuntary trembling

Rapid, uncontrollable movements of the eyes

Visual disturbances, such as double vision,

blurred vision, decreased vision, difficulty

focusing

Sensation of spinning (vertigo), ringing in the

ears, ear pain

Shortness of breath

Cough

Nose bleed

Fever

Weakness

General unwell feeling

Vomiting

Constipation

Abdominal pain or discomfort in the abdomen

Indigestion

Stomach or intestinal infection/inflammation

Dry mouth

Hair loss

Itching

Joint pain or swelling

Muscle cramp or spasm, muscle pain or

weakness

Chest pain

Weight gain

Uncommon side effects - effects that occur

in up to 1 in 100 users:

Abnormal blood count, including decrease in

amount of white blood cells or platelets or an

increase in the amount of eosinophils

Low potassium levels in the blood

Increase in liver enzyme levels

Swollen glands in the neck, armpit or groin

Increased appetite

Elevated mood

Hearing, seeing or feeling things that do not

exist, severe mental disturbances (psychosis)

Feeling apathetic, unusual suspicions, panic

attacks

Problems with reading, speech disorders,

problems with writing

Restlessness or hyperactivity

Slowed thinking, decreased wakefulness or

alertness

Slow body movements or reduced mobility

Abnormal and involuntary or repetitive muscle

movements

Fainting

Impaired/abnormal sense of touch

Impaired or distorted or lack of sense of smell

Feeling/sensation preceding a migraine or a

certain type of seizure

Eye problems including dry eyes, sensitivity of

the eyes to light, involuntary eyelid twitching,

tearing

Decrease or loss of hearing, hearing loss in

one ear

Irregular or slow heartbeat, palpitations

Low blood pressure or drop in blood pressure

upon standing up (therefore, some people

taking Topiramate Teva may feel faint, dizzy

or may pass out when they stand or sit up

suddenly)

Hot flushes, feeling hot

Pancreatitis

Flatulence, heartburn, feeling of bloating or

fullness

Bleeding gums, increased production of

saliva, drooling, bad breath

Increased thirst sensation and drinking large

amounts of fluids

Skin discoloration

Muscle stiffness, side pain

Blood in urine, urinary incontinence, a sense

of urgency in urination, pain in the kidney area

Sexual dysfunction, difficulty getting or

keeping an erection

Flu-like illness

Cold sensation in the fingers and toes

Feeling drunk

Learning disabilities

Rare side effects - effects that occur in up

to 1 in 1,000 users:

Abnormally elevated mood

Loss of consciousness

Blindness in one eye, temporary blindness,

night blindness

Lazy eye

Swelling in and around the eye

Raynaud’s phenomenon - a disorder that

affects the blood vessels in the fingers and

toes; causes pain, tenderness, numbness,

tingling sensation or color change (from white

to blue to red) in the fingers and toes when

exposed to the cold

Inflammation of the liver, liver failure

Stevens-Johnson

syndrome

life-

threatening skin reaction, in which the upper

layer of the skin separates from the lower

layer, manifested by warts in many mucosal

sites (such as the mouth, nose, and eyes), a

skin rash and blisters

Erythema multiforme - a condition in which

red dots appear on the surface of the skin,

that can turn into blisters

Bad skin odor

Discomfort in the arms or legs

Kidney problems

Additional side effects, whose frequency

is unknown:

Maculopathy - a disease of the macula

area of the eye. This is the small spot in the

retina where vision is keenest. If you notice

a change or decrease in vision - refer to the

doctor.

Toxic epidermal necrolysis - a skin effect

associated with the Stevens Johnson

syndrome but more severe. It is also life-

threatening and characterized by widespread

blisters and separation of the skin (see rare

side effects).

Side effects in children

The side effects in children are generally similar

to those seen in adults. However, the following

side effects may be more common in children

than in adults:

Concentration problems

Increased acid level in the blood

Thoughts of serious self-harm

Tiredness

Decreased or increased appetite

Aggression, abnormal behavior

Difficulty falling or staying asleep

Feeling of unsteadiness when walking

Not feeling well

Decrease in potassium levels in the blood

Not displaying or not feeling emotions

Watery eyes

Slow or irregular heartbeat

Other side effects that may occur in children:

Common side effects - occur in up to 1 in

10 users

Sensation of spinning (vertigo)

Vomiting

Fever

Uncommon side effects - occur in up to 1

in 100 users

Increased eosinophil (a type of white blood

cell) level in the blood

Hyperactivity

Feeling hot

Learning disabilities

Pay attention ,particularly in children, if a

decrease in sweating and an increase in body

temperature (fever) develop, especially in hot

weather.

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/get

sequence.aspx?formType=AdversEffectMedic

@moh.gov.il

5. HOW TO STORE THE MEDICINE?

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 the doctor.

Do not use the medicine after the expiry date

(exp. date) appearing on the package. The

expiry date refers to the last day of that month.

Store in a dry place, below 25ºC.

6. fURTHER INfORMATION

In addition to the active ingredient, the medicine

also contains:

lactose

monohydrate,

microcrystalline

cellulose, pregelatinized starch, sodium starch

glycolate, magnesium stearate, colloidal silicon

dioxide, polydextrose, hypromellose (present

only in the 25 mg, 100 mg, 200 mg).

polyvinyl alcohol, talc (present only in the

50 mg)

iron oxide yellow (present only in the 50 mg

and 100 mg).

iron oxide black (present only in the 100 mg).

iron oxide red, FD&C red # 40, FD&C blue #2

(present only in the 200 mg).

Topiramate Teva 25 mg: Each tablet contains

30 mg lactose and approximately 0.1 mg

sodium

Topiramate Teva 50 mg: Each tablet contains

22 mg lactose and approximately 0.1 mg

sodium

Topiramate Teva 100 mg: Each tablet contains

44.5 mg lactose and approximately 0.25 mg

sodium

Topiramate Teva 200 mg: Each tablet contains

89 mg lactose and approximately 0.5 mg

sodium

What the medicine looks like and the content

of the package

Topiramate Teva 25 mg: a film-coated, oblong,

white tablet, with “T25” imprinted on one side

and the other side is smooth.

Topiramate Teva 50 mg: a film-coated, oblong,

light yellow tablet. One side has a score line with

“T” imprinted on one side of the score line and

“50” on the other side of the score line. The other

side of the tablet is smooth.

Topiramate Teva 100 mg: a film-coated,

oblong, yellow tablet. One side has a score line

with “T” imprinted on one side of the score line

and “100” on the other side of the score line. The

other side of the tablet is smooth.

Topiramate Teva 200 mg: a film-coated,

oblong, pink-orange tablet. One side has a

score line with “T” imprinted on one side of the

score line and “200” on the other side of the

score line. The other side of the tablet is smooth.

Each package contains 30 or 60 tablets in trays

(blisters).

Not all package sizes may be marketed. Not all

strengths 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 September 2011 and was

updated in accordance with the Ministry of

Health guidelines in August 2018

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Topiramate Teva 25 mg:

135.15.31177

Topiramate Teva 50 mg:

135.16.31176

Topiramate Teva 100 mg:

135.17.31253

Topiramate Teva 200 mg:

135.18.31254

TOPI TAB PL SH 061118

TOPI TAB PL SH 061118

نم 1 ىتح ىدل رهظت ضارعأ ـ ةردان ةيبناج ضارعأ :لمعتسم 1000 نيب عافترإ ىلإ يدؤي يذلا نيعلا يف لئاوس سابتحإ( اموكولچ .)ةيؤرلا يف يندت وأ ملأ ،نيعلا لخاد طغضلا يف لاح يف بيبطلا غيلبت بجي ةيفاضإ ةيبناج ضارعأ :تمقافت رثكأ ىدل رهظت ضارعأ ـ

ً

ادج ةعئاش ةيبناج ضارعأ :ةرشع نم دحاو لمعتسم نم ةرجنحلا يف ملأ ،حشر ،فنلأا ناقتحإ مسجلا نم ةفلتخم ءازجأ يف ردخ وأ/و ملأ ،زخو مونلا ىلإ ليملا وأ قاهرإ راود لاهسإ نايثغ نزولا صقانت نم 1 ىتح ىدل رهظت ضارعأ ـ ةعئاش ةيبناج ضارعأ :نيلمعتسم 10 نيب )مدلل ضفخنم دادعت( مد رقف ،ةكح ،رارمحإ ،دلجلا يف حفط لثم( يسسحت لعف در )ىرش ،هجولا يف خافتنإ ماعطلل ةيهشلا نادقف وأ ماعطلل ةيهشلا ضافخنإ يدايتعإ ريغ فرصت ،بضغ ،قلق ،ةيناودع مونلل وأ مونلا ىلإ دولخلا يف ةبوعص قطنلا يف مثعلتلا ،قطنلا يف لكاشم ءانثأ تابثلا مدعب روعشلا ،قسانتلا مدع وأ ةكرحلا لقث يشملا ةينيتور تاطاشن مامتإ ىلع ةردقلا يف ضافخنإ قاذملا ةساح نادقف/ريغت/ضافخنإ يدارإ لا نافجر

نينيعلل ةرطيسلا نع ةجراخ ،ةعيرس تاكرح ،ةيبابض ةيؤر ،ةيؤرلا جاودزإ لثم ةيؤرلا يف تابارطضإ

ةيؤرلا زكرمت ةبوعص ،ةيؤرلا يندت يف ملأ ،نينذلأا يف نينط ،)وچيتريڤ( راودب روعشلا

.نينذلأا سفنتلا يف قيض لاعس

فاعر ةنوخس ماع فعض ديج ريغ ماع روعش تاؤيقت كاسمإ نطبلا يف جاعزنإ وأ نطبلا يف ملاآ ةيمضه تابوعص ءاعملأا وأ ةدعملا يف باهتلإ/ثولت مفلا يف فافج رعشلا نادقف ةكح لصافملا يف خافتنإ وأ ملاآ تلاضعلا يف فعض وأ ملاآ ،يلضع جنشت وأ صلقت ردصلا يف ملأ نزولا يف ةدايز ىتح ىدل رهظت ضارعأ ـ ةعئاش ريغ ةيبناج ضارعأ :لمعتسم 100 نيب نم 1 مدلا ايلاخ ةيمك يف ضافخنإ لمشي ،ميلس ريغ مد دادعت تاض

محلا ةيمك عافترإ وأ ةيومدلا تاحيفصلا وأ ءاضيبلا مدلا يف مويساتوپلل ةضفخنم تايوتسم دبكلا تاميزنإ ةبسن يف عافترإ نيلجرلا جرفنم يف وأ طبلإا يف ،قنعلا يف ددغلا خافتنإ ماعطلل ةيهشلا ةدايز

فهرم جازم تابارطضإ ،ةدوجوم ريغ ءايشأب روعشلا وأ ةيؤر ،عامس )ناهذ( ةريطخ ةيسفن عله تابون ،ةيدايتعإ ريغ كوكش ،ةلاابملا مدعب روعشلا يف لكاشم ،قطنلا يف تابارطضإ ،ةءارقلا يف لكاشم ةباتكلا طاشنلا طرف وأ ةحارلا ةلق ةظقيلا وأ هابتنلإا يندت ،ريكفتلا يف ؤطابت ةكرحلا يندت وأ مسجلل ةئيطب تاكرح تلاضعلل ةرركتم وأ ةيدارإ لاو ةذاش تاكرح ءامغإ ةميلس ريغ/ةلتخم سمل ةساح مشلا ةساح نادقف وأ ةهوشم وأ ةررضتم مش ةساح جلاتخلإا نم عون وأ انيرچيملا قبسي ساسحإ/روعش نينيعلا ةيساسح ،نينيعلا فافج لمشت نينيعلا يف لكاشم عمدت ،نينفجلل ةيدارإ لا تاجنشت ،ءوضلل ةدحاو نذأ يف عمسلا نادقف ،عمسلا نادقف وأ ضافخنإ بلق تابرض ،ءيطب وأ يدايتعإ ريغ ضبن لاقتنلإا دنع مدلا طغض ضافخنإ وأ ضفخنم مد طغض نولوانتي نيذلا نينيعم صاخشأ نإف اذل( فوقولا ةيعضول ىمغي دق وأ راود ،ءامغإب نورعشي دق عڤيت تاماريﭘوت )ئجافم لكشب نوسلجي وأ نوفقي امدنع مهيلع رحلاب روعشلا ،رحلا نم تابه سايركنبلا يف باهتلإ ءلاتمإ وأ خافتنإب روعشلا ،ناقرح ،تازاغ ،باعللا نلايس ،باعللا جاتنإ يف ةدايز ،ةثللا نم فزن مفلا نم ةهيرك ةحئار لئاوسلا نم ةريبك تايمك برشو شطعلاب روعشلا ةدايز

دلجلا نول يف ريغت يبناج ملأ ،تلاضعلا بلصت حاحللإاب روعشلا ،لوبتلا ىلع ةرطيسلا مدع ،لوبلا يف مد ىلكلا ةقطنم يف ملأ ،لوبتلا ىلع لوصولا يف ةبوعص ،ةيسنجلا ةفيظولا يف تابارطضإ

كلذ ىلع ظافحلا وأ يركذلا بيضقلا باصتنإ ىلإ ازنإولفنلإاب هيبش ضرم نيمدقلاو نيديلا عباصأ يف ةدوربب روعشلا

لمثلاب روعشلا

ملعتلا يف تابوعص نم 1 ىتح ىدل رهظت ضارعأ ـ ةردان ةيبناج ضارعأ :لمعتسم 1000 نيب يداع ريغ لكشب فهرم جازم يعولا نادقف يليل ىمع ،تقؤم ىمع ،ةدحاو نيع يف ىمع ةلوسك نيع نيعلا طيحمو نيعلا خافتنإ بارطضإ ـ »

Raynaud’s phenomenon

ونير ةرهاظ« .نيمدقلاو نيديلا عباصأ يف ةيومدلا ةيعولأا ىلع رثؤي ريغت وأ زخوب روعشلا ،ردخ ،ةيساسح ،ملأ ىلإ يدؤي عباصأ يف )رمحلأا ىلإ قرزلأا ىلإ ضيبلأا نم( نوللا دربلل ضرعتلا دنع نيمدقلاو نيديلا يدبك لشف ،دبكلا باهتلإ

Stevens Johnson

نوسنوج نڤيتس ةمزلاتم« ةايحلا ىلع

ارطخ لكشي يدلج لعف در ـ »

syndrome

،ةيلفسلا ةقبطلا نع دلجلل ةيولعلا ةقبطلا هيف لصفنت ثيحب ،مفلا لثم( ةريثك ةيطاخم قطانم يف ليلآثب لثمتي يذلا .تلاصيوحو دلجلا يف حفط ،)نينيعلاو فنلأا ءارمح طقن اهيف رهظت ةلاح ـ »لاكشلأا ةددعتم ىمامح«

تلاصيوح ىلإ لوحتت نأ اهنكمي يتلا دلجلا حطس ىلع دلجلل ةهيرك ةحئار نيلجرلا وأ نيعارذلا يف جاعزنإ ىلكلا يف لكاشم :فورعم ريغ اهعويش ،ةيفاضإ ةيبناج ضارعأ »)ةخطللا( ةعقبلا« ةقطنم ضرم ـ »

Maculopathy

«

يتلا ةيكبشلا يف ةريغصلا ةطقنلا يه كلت .نيعلا يف ريغت ظحلات تنك لاح يف .

دح رثكأ ةيؤرلا اهيف نوكت .بيبطلا ةعجارم بجي ـ ةيؤرلا يف يندت وأ

Toxic epidermal

يمسلا يرخنلا ةرشبلا للاحنإ ةمزلاتم

نڤيتس ةمزلاتمب قلعتي يدلج ضرع ـ

necrolysis

ةايحلا ىلع

ارطخ لكشي

اضيأ وه .رطخأ هنكل نوسنوج رظنأ( دلجلا لاصفنإو ةرشتنم تلاصيوحب زيمتي وهو .)ةردان ةيبناج ضارعأ لافطلأا ىدل ةيبناج ضارعأ كلت ةماع ةروصب هبشت لافطلأا ىدل ةيبناجلا ضارعلأا دق ةيلاتلا ةيبناجلا ضارعلأا نكل .رابكلا ىدل ةدوجوملا :رابكلا ىدل هيلع وه امم لافطلأا ىدل رثكأ ةعئاش نوكت زيكرتلا ةبوعص - مدلا يف ةضومحلا ةبسن عافترإ

ريطخ لكشب يتاذلا ىذلأا قاحلإ نع راكفأ

قاهرإ

ماعطلل ةيهشلا ةدايز وأ ضافخنإ

يدايتعإ ريغ فرصت ،ةيناودع - مونلل وأ مونلا ىلإ دولخلا ةبوعص - يشملا للاخ تابثلا مدعب روعشلا

ديج ريغ روعش - مدلا يف مويساتوپلا بسن ضافخنإ

فطاوعلاب روعشلا مدع وأ راهظإ مدع - نينيعلا عمدت

يدايتعإ ريغ وأ ءيطب بلق مظن

:لافطلأا ىدل ثدحت دق ىرخأ ةيبناج ضارعأ نيب نم 1 ىتح ىدل رهظت ـ ةعئاش ةيبناج ضارعأ نيلمعتسم 10 )وچيتريڤ( راودب روعشلا

ؤيقت

ةنوخس - نم 1 ىتح ىدل رهظت ـ ةعئاش ريغ ةيبناج ضارعأ لمعتسم 100 نيب )ءاضيبلا مدلا تايرك نم عون( تاضمحلا ةبسن عافترإ

مدلا يف طاشن طرف - ةنوخسب روعشلا

ملعتلا يف تابوعص - روطتي اذإ اميف لافطلأا ىدل صاخ لكشب هابتنلإا بجي مسجلا ةرارح ةجرد يف عافترإو قرعتلا يف ضافخنإ مهيدل .راحلا سقطلا يف ةصاخ )ةنوخس( ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ ركذي مل يبناج ضرع نم يناعت امدنع وأ ،ةيبناجلا .بيبطلا ةراشتسإ كيلع ،ةرشنلا يف ةيبناج ضارعأ نع غيلبتلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا ىلع طغضلا ةحصلا ةرازو عقومل ةيسيئرلا ةحفصلا ىلع دوجوملا »يئاود رشابملا جذومنلا ىلإ كهجوي يذلا )

www.health.gov.il

:طبارلا حفصت قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل

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

/getsequence.aspx?formType=AdversEffe

ctMedic@moh.gov.il

؟ءاودلا نيزخت ةيفيك )5 يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم ؤيقتلا ببست لا .ممستلاب مهتباصإ يدافتل كلذو عضرلا وأ/و .بيبطلا نم ةحيرص تاميلعت نودب ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا خيرات ريشي .ةبلعلا رهظ ىلع رهظي يذلا )exp. date( .رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ءاهتنإ .ةيوئم ةجرد 25 نود فاج ناكم يف نيزختلا بجي ةيفاضإ تامولعم )6

اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي

lactose monohydrate, microcrystalline cellulose,

pregelatinized starch, sodium starch glycolate,

magnesium stearate, colloidal silicon dioxide,

polydextrose, hypromellose (present only in the

25 mg, 100 mg, 200 mg).

polyvinyl alcohol, talc (present only in the 50

mg).

iron oxide yellow (present only in the

50 mg and 100 mg).

iron oxide black (present only in the

100 mg).

iron oxide red, FD&C red # 40, FD&C blue #2

(present only in the 200 mg).

غلم 30 ىلع صرق لك يوتحي :غلم 25 عڤيت تاماريپوت مويدوص غلم 0٫1 يلاوح ىلعو زوتكل غلم 22 ىلع صرق لك يوتحي :غلم 50 عڤيت تاماريپوت مويدوص غلم 0٫1 يلاوح ىلعو زوتكل غلم 44٫5 ىلع صرق لك يوتحي :غلم 100 عڤيت تاماريپوت مويدوص غلم 0٫25 يلاوح ىلعو زوتكل غلم 89 ىلع صرق لك يوتحي :غلم 200 عڤيت تاماريپوت مويدوص غلم 0٫5 يلاوح ىلعو زوتكل ؟ةبلعلا ىوتحم امو ءاودلا ودبي فيك ضيبأ هنول لواطم يلطم صرق :غلم 25 عڤيت تاماريپوت .سلمأ يناثلا بناجلاو دحاو بناج يف »

« ـل ةعابطلا عم رفصأ هنول لواطم يلطم صرق :غلم 50 عڤيت تاماريپوت

« ـل ةعابطلا عم رطشلل طخ دجوي دحاو بناج يف .حتاف يناثلا فرطلا يف »

« ـو رطشلا طخ نم دحاو فرط يف .سلمأ صرقلل يناثلا بناجلا .رطشلا طخل هنول ،لواطم يلطم صرق :غلم 100 عڤيت تاماريپوت

« ـل ةعابطلا عم رطشلل طخ دجوي دحاو بناج يف .رفصأ يناثلا فرطلا يف »

« ـو رطشلا طخل دحاو فرط يف .سلمأ وه صرقلا نم يناثلا بناجلا .رطشلا طخل هنول ،لواطم يلطم صرق :غلم 200 عڤيت تاماريپوت عم رطشلل طخ دجوي دحاو بناج يف .يلاقترب ـ يدرو يف »

« ـو رطشلا طخل دحاو فرط يف »

« ـل ةعابطلا .سلمأ وه صرقلل يناثلا بناجلا .رطشلا طخل يناثلا فرطلا .)رتسيلب( تاحيول نمض

اصرق 60 وأ 30 ىلع ةبلع لك يوتحت قوست لاأ زئاجلا نم .بلعلا ماجحأ ةفاك ق

وست لاأ زئاجلا نم .ةيئاودلا تارايعلا ةفاك هناونعو زايتملإا بحاصو جتنملا مسإ ،.ض.م ةيبطلا تارضحتسملاو ةيودلأل عڤيت .اڤكت ـ حتيﭘ ،3190.ب.ص صح

ف اهاوتحمو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ تاميلعت بجومب اهثيدحت متو 2011 لوليأ خيرات يف صخ

رو 2018 بآ خيراتب ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر :ةحصلا ةرازو 135 15 31177 :غلم 25 عڤيت تاماريﭘوت 135 16 31176 :غلم 50 عڤيت تاماريﭘوت 135 17 31253 :غلم 100 عڤيت تاماريﭘوت 135 18 31254 :غلم 200 عڤيت تاماريﭘوت ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم صصخم ءاودلا نإف ،كلذ نم مغرلا ىلع .ركذملا ةغيصب .نيسنجلا لاكل ةمتت

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