LAMOGINE 25 MG

Israel - English - Ministry of Health

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Active ingredient:
LAMOTRIGINE
Available from:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
ATC code:
N03AX09
Pharmaceutical form:
TABLETS
Composition:
LAMOTRIGINE 25 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
Therapeutic group:
LAMOTRIGINE
Therapeutic area:
LAMOTRIGINE
Therapeutic indications:
Epilepsy : Monotherapy in adults and children over 12 years of age: Simple partial seizures. Complex partial seizures. Secondarily generalised tonic clonic seiaures. Primary generalised tonic clonic seizures. Add- on therapy in adults and children over 2 years of age: Simple partial seizures. Complex partial seizures. Secondarily generalised tonic clonic seizures. Primary generalised tonic clonic seizures. Adults ( 18 years of age and over) : Lamotrigine is indicated for the prevention of mood episodes in patients with bipolar disorder predominantly by preventing depressive episodes.
Authorization number:
123 87 30352 00
Authorization date:
2011-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

25-03-2020

103238010

1119G

Patient leaflet in accordance with the Pharmacists’ Regulations

(Preparations) – 1986

The medicine is dispensed according to a physician’s

prescription only

Lamogine 25 mg

Tablets

Each tablet contains: 25 mg

lamotrigine

Lamogine 50 mg

Tablets

Each tablet contains: 50 mg

lamotrigine

Lamogine 100 mg

Tablets

Each tablet contains: 100 mg

lamotrigine

Lamogine 200 mg

Tablets

Each tablet contains: 200 mg

lamotrigine

List of the additional ingredients detailed in section 6.

Read the entire leaflet carefully before using the medicine. This

leaflet contains concise information about the medicine. If you have

any further questions, refer to the physician or the pharmacist.

This medicine has been prescribed for you. Do not pass it on to

others. It may harm them even if it seems to you that their medical

condition is similar.

1. What is the medicine intended for?

Adults, adolescents and children above the age of 12 years:

Lamogine

monotherapy

epilepsy,

partial

seizures

generalized tonic-clonic seizures.

Adults, adolescents and children above the age of two years:

As add-on therapy in epilepsy, partial seizures and generalized tonic-

clonic seizures, in cases that are not controlled with other drugs.

Adults (from age 18 and above):

For prevention of mood disturbances, mainly depressive conditions

in patients with bipolar disorder.

Therapeutic group: Lamogine belongs to a group of medicines called

anticonvulsants.

2. Before using the medicine

Do not use this medicine if:

you are sensitive (allergic) to the active ingredient lamotrigine

or to any of the additional ingredients contained in the medicine

(listed in section 6). If this applies to you: Tell your physician

and don’t take Lamogine.

Special warnings regarding the use of the medicine

Talk to your physician or pharmacist before taking Lamogine:

if you have any kidney problems

if you have ever developed a rash after taking lamotrigine or

other medicines for bipolar disorder or epilepsy

if you have ever developed meningitis after taking lamotrigine

(read the description of these symptoms in section 4 of this leaflet:

‘rare side effects’)

if you are already taking medicine that contains lamotrigine

If any of these applies to you:

Tell your physician, who may decide to lower the dose or that

Lamogine is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamogine get an allergic reaction

or potentially life-threatening skin reaction, which may develop into

more serious problems if they are not treated. These can include

Stevens-Johnson syndrome )SJS(, toxic epidermal necrolysis )TEN(

Drug

Reaction

with

Eosinophilia

Systemic

Symptoms

(DRESS). You need to know the symptoms to look out for while you

are taking Lamogine.

Read the description of these symptoms in section 4 of this

leaflet under ‘Potentially life-threatening reactions: get medical help

straight away’.

Thoughts of harming yourself or suicide

Anti-epileptic

medicines

used

treat

several

conditions,

including epilepsy and bipolar disorder. People with bipolar disorder

can sometimes have thoughts of committing suicide or harming

themselves. If you have bipolar disorder, you may be more likely to

think like this:

when you first start treatment or with a change in dosage

if you previously had thoughts about harming yourself or about suicide

if you are under 25 years old

If you have distressing thoughts or experiences, or if you notice that you

feel worse or develop new symptoms while you’re taking Lamogine:

Refer to a physician as soon as possible or go to the nearest

hospital for help.

You may find it helpful to tell a family member, caregiver or a

close friend that you can become depressed or have significant

mood swings and ask them to read this leaflet. You can ask

them to tell you if they are concerned about your depression or

about other changes in your behavior.

A small number of people being treated with antiepileptics such as

Lamogine have also had thoughts of harming or killing themselves.

If at any time you have these thoughts, immediately contact your

physician.

If you’re taking Lamogine for epilepsy

The seizures in some types of epilepsy may occasionally become

worse or happen more often while you’re taking Lamogine. Some

patients may experience severe seizures, which may cause serious

health problems. If your seizures happen more often or if you

experience a severe seizure while you’re taking Lamogine: Refer to

a physician as soon as possible.

Lamogine is not intended for people aged under 18 years to

treat bipolar disorder. Medicines to treat depression and other

mental health problems increase the risk of suicidal thoughts and

behaviour in children and adolescents aged under 18 years.

Other medicines and Lamogine

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

including non-prescription medicines and food supplements,

tell the physician or the pharmacist. Your physician needs to

know if you are taking other medicines to treat epilepsy or mental

health problems. This is to make sure you take the correct dosage of

Lamogine. These medicines include:

oxcarbazepine,

felbamate,

gabapentin,

levetiracetam,

pregabalin, topiramate or zonisamide, used to treat epilepsy

lithium, olanzapine or aripiprazole, used to treat mental health

problems

bupropion, used to treat mental health problems or to stop

smoking

Tell your physician if you are taking any of these.

Some medicines interact with Lamogine or make it more likely that

people will have side effects. These include:

valproate, used to treat epilepsy and mental health problems

carbamazepine, used to treat epilepsy and mental health problems

phenytoin, primidone or phenobarbitone, used to treat epilepsy

risperidone, used to treat mental health problems

rifampicin, which is an antibiotic

medicines used to treat Human Immunodeficiency Virus (HIV)

infection (a combination of lopinavir and ritonavir or atazanavir

and ritonavir)

hormonal contraceptives, such as contraceptive pill (see below).

Tell your physician if you are taking, or if you start or stop taking

any of these.

Hormonal contraceptives (such as contraceptive pill) can affect

the way Lamogine works

Your physician may recommend that you use a particular type of

hormonal contraceptive or another method of contraception such as

condoms. If you are using a hormonal contraceptive like contraceptive

pill, your physician may take samples of your blood to check the level

of lamotrigine. If you are using a hormonal contraceptive or if you

plan to start using one: Talk to your physician, who will discuss

suitable methods of contraception with you.

Lamogine can also affect the way hormonal contraceptives work,

although it’s unlikely to make them less effective. If you are using a

hormonal contraceptive and you notice any changes in your menstrual

pattern, such as breakthrough bleeding or spotting between periods:

Tell your physician. These may be signs that Lamogine is affecting

the way your contraceptive is working.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning

to have a baby, ask your physician or pharmacist for advice

before taking this medicine.

You should not stop treatment without discussing this with

your physician. This is particularly important if you have epilepsy.

Pregnancy may alter the effectiveness of Lamogine, so you may

need blood tests and your dose of Lamogine may be adjusted.

There may be a small increased risk of birth defects, including a

cleft lip or cleft palate, if Lamogine is taken during the first 3 months

of pregnancy.

Your doctor may advise you to take extra folic acid if you’re

planning

become

pregnant

while

you’re

pregnant.

If you are breast-feeding, or are planning to breast-feed, ask

your physician or pharmacist for advice before taking this

medicine. The active ingredient of Lamogine passes into breast

milk and may affect your baby. Your physician will discuss the risks

and benefits of breast-feeding while you’re taking Lamogine and will

check your baby from time to time if you decide to breast-feed.

Driving and using machines

Lamogine can cause dizziness and double vision. Don’t drive or

use machines unless you are sure you’re not affected. Children

should be warned against riding bicycles or playing near roads, etc.

If you have epilepsy, talk to your physician about driving and

using machines.

3. How should you use the medicine?

Always use according to the physician’s instructions. You should

check with the physician or the pharmacist if you are not sure.

The dosage and treatment will be determined only by the attending

physician on an individual basis according to the severity of the

disease.

Lamogine is indicated as a monotherapy for epilepsy only for adults,

adolescents and children above the age of 12 years.

Lamogine is indicated as an add-on therapy for epilepsy for children

above the age of two years, adolescents and adults.

Lamogine for treatment of bipolar disorder is indicated for adults over

the age of 18.

The medicine is to be taken at specific time intervals as determined

by the attending physician.

How much Lamogine to take

It may take a while to find the best dosage of Lamogine for you. The

dosage you take will depend on:

1. your age

2. whether you are taking Lamogine with other medicines

3. whether you have any kidney or liver problems

Your physician will prescribe a low dosage to start and gradually

increase the dosage over a few weeks until you reach a dosage

that works for you (called the effective dosage). Never take more

Lamogine than your physician tells you to.

Lamogine is not recommended for children aged under 2 years.

Do not exceed the recommended dose.

How to take your dose of Lamogine

Take your dose of Lamogine once or twice a day, as your physician

instructed you. It can be taken with or without food.

Always take the full dose that your physician has prescribed for you.

Your physician may also advise you to start or stop taking other

medicines, depending on what condition you’re being treated for and

the way you respond to treatment.

Lamogine tablets can be swallowed whole with a little water.

For children and those who have difficulty swallowing tablets: the

tablet can be placed in spoonful of water and swallowed after a few

minutes, when the tablet has completely disintegrated.

Lamogine 25 mg – As there is no score line, do not split. There is no

information about crushing/chewing.

Lamogine 50 mg, 100 mg, 200 mg – You may split. There is no

information

about

crushing/chewing.

If you accidently have taken a higher dosage

If you have taken an overdose or if a child has accidentally swallowed

the medicine, refer immediately to a physician or to the hospital

emergency room and bring the package of the medicine with you.

If you take too much Lamogine, you may be more likely to have

serious side effects which may be fatal. Someone who has taken

too much Lamogine may have any of these symptoms:

rapid, uncontrollable eye movements (nystagmus)

clumsiness and lack of coordination, affecting balance (ataxia)

heart rhythm changes (detected usually on ECG)

loss of consciousness, fits (seizures) or coma

If you forgot to take a single dose of Lamogine

In this case, don’t take extra tablets to make up for a forgotten

dose. Take your next dose at the usual time.

If you forgot to take several doses of Lamogine

Ask your physician for advice on how to start taking it again. It

is important that you do this.

Don’t stop taking Lamogine without advice

You must take Lamogine for as long as your physician recommends.

Don’t stop unless your physician advises you to.

If you’re taking Lamogine for epilepsy

To stop taking Lamogine, it is important that the dosage is

reduced gradually, over about 2 weeks. If you suddenly stop taking

Lamogine, your epilepsy may come back or get worse.

If you’re taking Lamogine for bipolar disorder

Lamogine may take some time to work, so you are unlikely to feel

better straight away. If you stop taking Lamogine, your dosage will

not need to be reduced gradually but you should still talk to your

physician first, if you want to stop taking Lamogine.

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 other questions regarding the use of the medicine,

consult the physician or the pharmacist.

4. Side effects

As with any medicine, use of Lamogine may cause side effects in

some of the users. Do not be alarmed by reading the list of side

effects. You may not experience any of them.

Potentially life-threatening reactions: get medical help straight

away

A small number of people taking Lamogine develop an allergic

reaction or potentially life-threatening skin reaction, which may

develop into more serious problems if they are not treated.

These symptoms are more likely to happen during the first few

months

treatment

with

Lamogine,

especially

starting

dosage is too high or if the dosage is increased too quickly or if

Lamogine is taken with another medicine called valproate. Some of

the symptoms are more common in children, so parents should be

especially careful to watch out for them.

Symptoms of these reactions include:

skin rashes or redness, which may develop into life-threatening

skin reactions including widespread rash with blisters and peeling

skin, particularly occurring around the mouth, nose, eyes and

genitals )Stevens-Johnson syndrome(, extensive peeling of the skin

)more than 30% of the body surface - toxic epidermal necrolysis( or

extended rashes with liver, blood and other body organs involvement

(Drug Reaction with Eosinophilia and Systemic Symptoms which is

also known as DRESS hypersensitivity syndrome)

ulcers in the mouth, throat, nose or genitals

a sore mouth or red or swollen eyes (conjunctivitis)

a high fever, flu-like symptoms or drowsiness

swelling around your face or swollen glands in your neck, armpit

or groin

unexpected bruising or bleeding, or the fingers turning blue

a sore throat or more infections (such as colds) than usual

increased levels of liver enzymes seen in blood tests

an increase in a type of white blood cell (eosinophils)

enlarged lymph nodes

involvement of the organs of the body including liver and kidneys

In many cases, these symptoms will be signs of less serious side effects

but you must be aware that they are potentially life-threatening

and can develop into more serious problems, such as organ failure,

if they are not treated. If you notice any of these symptoms:

Refer to a physician immediately. Your physician may decide to

carry out tests on your liver, kidneys or blood and may tell you to stop

taking Lamogine. In case you have developed Stevens-Johnson

syndrome or toxic epidermal necrolysis, your physician will tell you

that you must never take Lamogine again.

Additional side effects

Very common side effects

Effects that may occur in more than one user in ten:

headache

skin rash

Common side effects

Effects that may occur in up to 1 in 10 users:

aggression or irritability

feeling sleepy or drowsy

feeling dizzy

tremors

insomnia

feeling agitated

diarrhoea

dry mouth

nausea or vomiting

feeling tired

pain in the back or joints, or elsewhere (in case these side effects

occur you should refer to the physician)

Uncommon side effects

Effects that may occur in up to 1 in 100 users:

clumsiness and lack of coordination (ataxia) (in case these side

effects occur you should refer to the physician)

double vision or blurred vision

unusual hair loss or thinning (alopecia)

Rare side effects

Effects that may occur in up to 1 in 1,000 users:

a life-threatening skin reaction )Stevens-Johnson syndrome( )see

also the information at the beginning of section 4)

a group of symptoms that appear together including: fever, nausea,

vomiting, headache, stiff neck and extreme sensitivity to bright

light. This may be caused by an inflammation of the membranes

that cover the brain and spinal cord (meningitis). These symptoms

usually disappear once treatment is stopped; however, if the

symptoms continue or get worse, contact your physician

rapid, uncontrollable eye movements (nystagmus) (in case these

side effects occur you should refer to the physician)

itchy

eyes,

with

discharge

crusting

eyelids

(conjunctivitis)

Very rare side effects

Effects that may occur in up to 1 in 10,000 users:

a life-threatening skin reaction )toxic epidermal necrolysis( )see

also the information at the beginning of section 4)

Drug

Reaction

with

Eosinophilia

Systemic

Symptoms

(DRESS) (see also the information at the beginning of section 4)

a high fever (see also the information at the beginning of section 4)

(in case this side effect occurs, you should refer to the physician)

swelling around the face (oedema) or swollen glands in the neck,

armpit or groin (enlarged lymph nodes) (see also the information at

the beginning of section 4)

changes in liver function, which will show up in blood tests or liver

failure and yellowing of the skin (see also the information at the

beginning of section 4)

a serious disorder of blood clotting, which can cause unexpected

bleeding or bruising (disseminated intravascular coagulation) (see

also the information at the beginning of section 4)

changes which may show up in blood tests - including reduced

numbers of red blood cells (anaemia), reduced numbers of white

blood cells (leucopenia, neutropenia, agranulocytosis), reduced

numbers of platelets (thrombocytopenia), reduced numbers of

all these types of cell (pancytopenia) and a disorder of the bone

marrow called aplastic anaemia

hallucinations (‘seeing’ or ‘hearing’ things that aren’t really there)

confusion (in case this side effect occurs you should refer to the

physician)

feeling ‘wobbly’ or unsteady when you move about (in case these

side effects occur you should refer to the physician)

uncontrollable body movements (tics), uncontrollable muscle spasms

affecting the eyes, head and upper body (choreoathetosis) or other

unusual body movements such as jerking, shaking or stiffness (in

case these side effects occur you should refer to the physician)

in people who already have epilepsy, seizures happening more often

in people who have Parkinson’s disease, worsening of the symptoms

lupus-like reaction )symptoms may include: back or joint pain which

sometimes may be accompanied by fever and/or general ill health).

Other side effects

Other side effects have occurred in a small number of users but their

exact frequency is unknown:

There have been reports of bone disorders including osteopenia

and osteoporosis (thinning of the bone) and fractures. Check with

your physician or pharmacist if you are on long-term anti-epileptic

medication, have a history of osteoporosis or take steroids

nightmares

If a side effect has appeared, if any of the side effects get worse

or when you suffer from a side effect that has not been mentioned

in the leaflet, you should consult the physician.

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://sideeffects.health.gov.il

You can also report by email to: safety@trima.co.il

5. How to store the medicine?

Avoid poisoning! This medicine and any other medicine should be

kept in a closed place out of the sight and reach of children and/or

infants in order to avoid poisoning. Do not induce vomiting without

an explicit instruction from the physician.

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

on the package/blister. The expiry date refers to the last day of

that month.

Store in a dry place, below 30°C.

6. Additional information

In addition to the active ingredient the medicine also contains the

following inactive ingredients:

lactose (anhydrous), microcrystalline cellulose, sodium starch,

glycollate, colloidal silicon dioxide, magnesium stearate.

Lamogine 25 mg contains 20 mg lactose.

Lamogine 50 mg contains 40 mg lactose.

Lamogine 100 mg contains 80 mg lactose.

Lamogine 200 mg contains 160 mg lactose.

What the medicine looks like and the content of the package:

Lamogine 25 mg

– round, white tablet.

Lamogine 50 mg

– round, white tablet with a score line on one side.

Lamogine 100 mg – round, white tablet with a score line on one side.

Lamogine 200 mg – oblong, white tablet with a score line on one side.

Manufacturer and license Holder: Trima, Israel Pharmaceutical

Products Maabarot Ltd., Maabarot 4023000, Israel.

This leaflet was checked and approved by the Ministry of Health

in April 2013 and revised in September 2019 in accordance with

Ministry of Health guidelines.

Registration number of the medicine in the National Drug Registry

of the Ministry of Health:

Lamogine 25 mg

123.87.30352.00

Lamogine 50 mg

123.88.30353.00

Lamogine 100 mg

123.89.30354.00

Lamogine 200 mg

123.90.30355.00

يف امب ةايحلا ىلع

ارطخ لكشت ةيدلج لعف دودر ىلإ ناروطتي دق ناذللا ،رارمحإ وأ يدلج حفط نينيعلا فنلأا ،مفلا لوح صخلأاب ثدحت يتلا ،دلجلا رشقتو تلاصيوح عم عساو يدلج حفط كلذ حطس نم 30٪ نم رثكأ( دلجلل عساو رشقت ،)نوسنوج ـ سنڤيتس ةمزلاتم( ةيلسانتلا ءاضعلأاو ىرخأ ءاضعأو مدلا ،دبكلا كارشإب ةعساو حفط تلااح وأ )يمسلا يرخنلا ةرشبلا للاحنإ - مسجلا

اضيأ فرعت يتلا ةيزاهج ضارعأو )eosinophilia( تاضمحلا ةرثك لمشي ءاودلل لعف در( (DRESS ةيساسحلا طرف ةمزلاتم مسإب

ةيلسانتلا ءاضعلأا يف وأ فنلأا يف ،ةرجنحلا يف ،مفلا يف تاحرقت

)نيعلا ةمحتلم باهتلإ( نينيعلا خافتنإ وأ نينيعلا رارمحإ وأ مفلا يف ملاآ

ساعنب روعشلا وأ ازنإولفنلإا هبشت ضارعأ ،ةيلاع ةنوخس

كيدل نيلجرلا جرفنم يف وأ طبلإا يف .ةبقرلا يف ددغلا خافتنإ وأ كهجو طيحم خافتنإ

عباصلأا قاقرزإ وأ ،ةعقوتم ريغ ةفزنأ وأ تامدك

)حشرلا لثم( داتعملا نع تاثولتلا ةدايز وأ ةرجنحلا يف ملأ

مدلا صوحف يف ظحلات يتلا دبكلا تاميزنإ بسن عافترإ

)تاضمحلا( ءاضيب مد ةيلخ نم نيعم عون ةدايز

ةيوافمللا ددغلا مخضت

ىلكلاو دبكلا كلذ يف امب مسج ءاضعأ كارشإ بجوتي نكل ةروطخ لقأ ةيبناج ضارعلأ تاملاع نوكت ضارـعلأا كلت ،تلااحلا نم ريثك يف ،ةروطخ رثكأ لكاشم ىلإ روطتت نأ نكميو ةايحلا ىلع

ً

ارطخ لكشت دق اهنأب

ً

اكردم نوكت نأ كيلع :ضارعلأا كلت نم

ايأ ظحلات تنك اذإ .اهتجلاعم متي مل اذإ كلذو ،ءاضعأ لشف لثم صوحف وأ كيتيلكل ،كدبكل صوحف ءارجإ ىلع كبيبط ررقي نأ زئاجلا نم .لاحلا يف بيبطلا عجار وأ نوسنوج سنڤيتس ةمزلاتم كيدل تروطت اذإ .نيجوملا لوانت نع فقوتلاب كدشري دق وهو مدلا .قلاطلإا ىلع ةيناث نيجوملا لوانت مدعب كبيبط كغلبيف ،يمسلا يرخنلا ةرشبلا للاحنإ ةيفاضإ ةيبناج ضارعأ ادج ةعئاش ةيبناج ضارعأ :ةرشع نم دحاو لمعتسم نم رثكأ ىدل رهظت دق ضارعأ

عادص

يدلج حفط ةعئاش ةيبناج ضارعأ :نيلمعتسم 10 لك نم 1 ىتح ىدل رهظت دق ضارعأ

طخس وأ ةيناودع

ساعنب وأ مونلا ىلإ ليمب روعشلا

راودب روعشلا

نافجر

قرأ

ءوده مدعب روعشلا

لاهسإ

مفلا فافج

ؤيقت وأ نايثغ

قاهرإب روعشلا

كلت روهظ لاح يف بيبطلا ةعجارم بجي( رخآ ناكمب وأ ،لصافملا يف وأ رهظلا يف ملاآ .)ةيبناجلا ضارعلأا ةعئاش ريغ ةيبناج ضارعأ :لمعتسم 100 لك نم 1 ىتح ىدل رهظت دق ضارعأ

ضارعلأا كلت روهظ لاح يف بيبطلا ةعجارم بجي( )حنر( قيسنتلا ةلقو يشملا يف لقث )ةيبناجلا

ةيؤرلا شوشت وأ ةيؤرلا جاودزإ

(alopecia( رعشلا ةفخ وأ رعشلل ذاش طقاست ةردان ةيبناج ضارعأ :لمعتسم 1000 لك نم 1 ىتح ىدل رهظت دق ضارعأ

تامولعملا

اضيأ رظنأ( )نوسنوج-سنڤيتس ةمزلاتم( ةايحلا ىلع

ارطخ لكشي يدلج لعف در (4 ةرقفلا ةيادب يف

ةيساسحو ةبقرلا بلصت ،عادص ،ؤيقت ،نايثغ ،ةنوخس :لمشت ةيوس رهظت ضارعأ ةعومجم يكوشلا لبحلاو غامدلا فلغت يتلا ةيشغلأا باهتلإ ةجيتن ثدحي دق اذه .عطاسلا ءوضلل ىوصق ترمتسإ اذإ نكلو جلاعلا نع فقوتلا دنع ةداع ضارعلأا هذه لوزت .)ةيغامدلا اياحسلا باهتلإ( كبيبط عجار تمقافت وأ

لاح يف بيبطلا ةعجارم بجي( )نينيعلا ةأرأر( نينيعلل ةرطيسلا نع ةجراخ ةعيرس تاكرح )ةيبناجلا ضارعلأا كلت روهظ

)نيعلا ةمحتلم باهتلإ( نينفجلا ىلع هبلصتو زارفإ عم ،نينيعلا يف ةكح ادج ةردان ةيبناج ضارعأ :لمعتسم 10000 لك نم 1 ىتح ىدل رهظت دق ضارعأ

تامولعملا

اضيأ رظنأ( )يمسلا يرخنلا ةرشبلا للاحنإ( ةايحلا ىلع ارطخ لكشي يدلج لعف در (4 ةرقفلا هيادب ىف

(DRESS( ةيزاهج ضارعأو )eosinophilia( تاضمحلا ةرثك لمشي ءاودلل لعف در (4 ةرقفلا ةيادب يف تامولعملا

اضيأ رظنأ(

روهظ لاح يف بيبطلا ةعجارم بجي( )4 ةرقفلا ةيادب يف تامولعملا

اضيأ رظنأ( ةيلاع ةنوخس )يبناجلا ضرعلا اذـه

مخضت( نيلجرلا جرفنم يف وأ طبلإا يف ،ةبقرلا يف ددغلا خافتنإ وأ )ةمذو( هجولا طيحم خافتنإ (4 ةرقفلا ةيادب يف تامولعملا

اضيأ رظنأ( )ةيوافمللا ددغلا

دلجلا رارـفــصإو دبكلا روــصق وأ مدـلا صوحف يف رهظت ىتلا ،دبكلا فئاـظو ىـف تاريغت (4 ةرقفلا هيادب ىف تامولعملا

اضيأ رظنأ(

لخاد رثتن

م طلجت( ةعقوتم ريغ تامدك وأ ةفزنأ ببسي دق يذلا ،مدلا رثخت يف ريطخ بارطضإ (4 ةرقفلا ةيادب يف تامولعملا

اضيأ رظنأ( )ةيعولأا

،)مد رقف( ءارمحلا مدلا ايلاخ ددع صقانت لمشت - مدلا صوحف يف رهظت نأ اهنأش نم يتلا تاريغت صقانت ،)ةببحملا تايركلا صقن ،تلادعلا ةلق ،ءاضيبلا تايركلا ةلق( ءاضيبلا مدلا ايلاخ ددع صقانت تايركلا ةلق( كلت مدلا ايلاخ ةفاك ددع صقانت ،)ةيومدلا تاحيفصلا ةلق( ةيومدلا تاحيفصلا ددع يجسنت لا مد رقف ىمسملا مظعلا عاخن يف بارطضإو )ةلماشلا

)ةقيقحلاب ةدوجوم ريغ ءايشأ ′عامس′ وأ ′ةيؤر′( نايذه

)يبناجلا ضرعلا اذه روهظ لاح يف بيبطلا ةعجارم بجي( كابترإ

كلت روهظ لاح يف بيبطلا ةعجارم بجي( ةكرحلا ءانثأ تابثلا ةلق وأ ′تابثلا مدع′ـب روعشلا )ةيبناجلا ضارعلأا

ةرطيسلا نع ةجراخ ةيلضع تاصلقت ،)tics- تاجلخ( ةرطيسلا نع ةجراخ مسج تاكرح ةيداع ريغ ىرخأ تاكرح وأ )صقر( مسجلا نم يولعلا مسقلاو سأرلا ،نينيعلا ىلع رثؤت يتلا هذه روهظ لاح يف بيبطلا ةعجارم بجي( بلصت وأ نافجر ،ةيدارإ لا تاكرح لثم مسجلل )ةيبناجلا ضارعلأا

عرصلا نم

ايلاح نوناعي نيذلا صاخشلأا ىدل ،تابونلا ةريتو ةدايز

نوسنيكراپ ءاد نم نوناعي نيذلا صاخشلأا ىدل ،ضارعلأا مقافت

قفارتت نكمي يتلا لصافملا يف وأ رهظلا يف ملاآ :لمشت نأ ضارعلأل نكمي( ةبئذلا هبشي لعف در )ةماع ةكعوب روعشلا وأ/و ةنوخسب

انايحأ ىرخأ ةيبناج ضارعأ :فورعم ريغ قيقدلا اهعويش نكلو نيلمعتسملا نم ليلق ددع ىدل ىرخأ ةيبناج ضارعأ تثدح دقل

ةشاشه( ماظعلا لخلختو مظعلا ةلق لمشت ماظعلا يف لكاشم ثودح نع ريراقت كانه تناك دقل عرصلل ةداضم ةيودأب جلاعتت تنك اذإ كتصاخ يلديصلا وأ بيبطلا عم صحفإ .روسكو )ماظعلا تاديئوريتسلا لوانتت تنك اذإ وأ ماظعلا لخلختل ةقباس كيدل تدجو اذإ ةليوط ةرتفل

)سيباوك( ع

ورم ملح مل يبناج ضرع نم يناعت امدنع وأ ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةرشنلا هذه يف ركذي نع غيلبت" طبارلا ىلع طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب ةحصلا ةرازو عقومل ةيسيئرلا ةحفصلا ىلع دوجوملا "يئاود جلاع بقع ةيبناج ضارعأ

قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل رشابملا جذومنلا ىلإ كهجوي )www.health.gov.il) https://sideeffects.health.gov.il :طبارلا حفصت safety@trima.co.il :ينورتكللإا ديربلا ربع ا

ضيأ غيلبتلا نكمي

5

.

؟ءاودلا نيزخت ةيفيك

ةيؤر لاجم نع

اديعب قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت نودب ؤيقتلا ببست لا .ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و لافطلأا يديأ لوانتمو .بيبطلا نم ةحيرص تاميلعت

/ةبلعلا رهظ ىلع رهظي يذلا )exp. date( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ عنم

.رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا خيرات ريشي .رتسيلبلا

.30°C تحت ،فاج ناكم يف نزخلا بجي

6

.

ةيفاضإ تامولعم

:ةيلاتلا ةلا

عفلا ريغ داوملا ىلع اضيأ رضحتسملا يوتحي ةلاعفلا ةداملل ةفاضلإاب

Lactose (anhydrous), microcrystalline cellulose, sodium starch

glycollate, colloidal silicon dioxide, magnesium stearate.

زوتكلا غلم 20 ىلع يوتحي غلم 25 نيجوملا زوتكلا غلم 40 ىلع يوتحي غلم 50 نيجوملا زوتكلا غلم 80 ىلع يوتحي غلم 100 نيجوملا زوتكلا غلم 160 ىلع يوتحي غلم 200 نيجوملا

؟ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك .ريدتسم ،ضيبأ صرق - غلم 25 نيجوملا .ةدحاو ةهج نم رطش طخ عم ريدتسم ضيبأ صرق - غلم 50 نيجوملا .ةدحاو ةهج نم رطش طخ عم ريدتسم ضيبأ صرق - غلم 100 نيجوملا .ةدحاو ةهج نم رطش طخ عم ليوط ضيبأ صرق - غلم 200 نيجوملا

تورابعم .ض.م تورابعم ةيليئارسإ

يبط تاجتنم ،اميرت :ليجستلا بحاصو جتن

ُ

ملا

.ليئارسإ ،4023000

متو ،2013 ناسين خيرات يف ة

حصلا ةرازو لب

ق نم اهيلع قيدصتلاو ةرشنلا هذه صحف

مت .2019 لوليأ خيرات يف ةحصلا ةرازو تاميلعت بجومب اهثيدحت

:ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر

123.87.30352.00

غلم 25 نيجوملا

123.88.30353.00

غلم 50 نيجوملا 123.89.30354.00 غلم 100 نيجوملا 123.90.30355.00 غلم 200 نيجوملا

،كلذ نم مغرلا ىلع .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف

103238010

PIL-0119-12

1119G

4023000

PIL-0119-12

ץרמ

2020

,ה/דבכנ ה/אפור

,ה/דבכנ ת/חקור

:ןודנה

ןוכדע

ולע

לש ןכרצל

:םירישכתה

Tablets

, 50 mg, 100 mg, 200 mg

Lamogine 25 mg

ליעפ ביכרמ

Lamotrigine 25 mg/ 50 mg/ 100mg/ 200mg

:היוותה

Epilepsy:

Monotherapy in adults and children over 12 years of age:

Simple partial seizures.

Complex partial seizures.

Secondarily generalised tonic clonic seiaures.

Primary generalised tonic clonic seizures.

Add- on therapy in adults and children over 2 years of age:

Simple partial seizures.

Complex partial seizures.

Secondarily generalised tonic clonic seizures.

Primary generalised tonic clonic seizures.

Bipolar disorder:

Adults (18 years of age and over):

Lamotrigine is indicated for the prevention of mood episodes in patients with bipolar disorder

predominantly by preventing depressive episodes

וננוצרב עידוהל

ולעב ןוכדע לחש

ןכרצל

ןודנבש רישכתה לש

ץומיא

ולע

לש

.רוקמה רישכת

ןולעה םוסרפל חלשנ תואירבה דרשמ לש טנרטניאה רתאבש תופורתה רגאמב

www.health.gov.il

לבקל ןתינו

תרבח ,םושירה לעבל הינפ י"ע ספדומ האופר ירצות ,המירת מ"עב תורבעמ םיילארשי תורבעמ ץוביק ,

4023000

:ןופלט ,

074-7141147

,הכרבב

מ"עב תורבעמ ,םיילארשי האופר ירצות ,המירת

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