Recto

Bodyweight 10 - 15 kg 15 - 30 kg 30 - 50 kg greater than 50 kg

PLIAGE-----

Do not take Sabril

x if you are allergic to vigabatrin or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking Sabril if: a You are breast-feeding a You are pregnant or plan to become pregnant a You have or have had depression or any other psychiatric illness in the past a You have had any kidney problems a You have had any problems with your eyes

Visual field loss (loss of sight from the edges of your field of vision) may occur during treatment with Sabril. You should discuss this possibility with your doctor ^_ before you begin treatment with this medicine. This visual field loss may be severe and irreversible, so it must be found early. A deterioration of this visual field loss after treatment is discontinued cannot be excluded. It is important that you inform your doctor promptly if you become aware of any change to your vision. Your doctor should perform a Visual field examination before you start taking Sabril and at regular intervals during the treatment.

If you develop symptoms like sleepiness, reduced consciousness and movements (stupor) or confusion consult your doctor who will decide upon a dose reduction or withdrawal.

A small number of people being treated with antiepileptics such as vigabatrin have had thoughts of harming or killing themselves. If at any time you have had these thoughts, immediately contact your doctor.

Children

Movement disorders have been seen in young infants treated for infantile spasms (West’s syndrome).If you observe unusual movement disorders in the child, consult your doctor who will decide if it is necessary to consider changing the treatment.

Other medicines and Sabril

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Sabril should not be used in combination with other medicines that may have side effects related to the eye.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take Sabril during pregnancy unless your doctor tells you to. Sabril may cause problems to unborn children. However, do not stop taking the medicine suddenly because this may risk the mother’s health as well as the baby’s health.

Sabril passes into breast milk. If you are breast-feeding, ask your doctor for advice before taking this medicine. Breast-feeding should not be done during treatment.

■

BH Driving and using machines

Do not drive or operate machinery if your epilepsy is uncontrolled.

Sabril sometimes causes symptoms like drowsiness or dizziness and your ability to concentrate and react may be reduced. If such symptoms occur whilst taking Sabril, you should not do any hazardous tasks such as driving or operating machinery.

Visual disorders, which can affect your ability to drive and use machines, have been found in some patients taking this medicine. If you wish to continue driving you must be tested regularly (every six months) for the presence of visual disorders even if you do not notice any changes to your vision.

If you take more Sabril than you should

If you or your child accidentally take too many Sabril tablets, tell your doctor immediately or go to your nearest hospital or Poison Information Centre.

Possible signs of overdose include drowsiness or loss/ depressed level of consciousness.

If you forget to take Sabril

If you forget to take a dose, take it as soon as you do remember. If it is almost time for your next dose, just take one dose. Do not take a double dose to make up for the missed dose.

If you stop taking Sabril

Do not stop taking this medicine without talking to your doctor. If your doctor decides to stop your treatment you will be advised to gradually reduce the dose. Do not stop suddenly as this may cause your seizures to occur again. -

L^J If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As with other antiepileptic medicines, some patients may experience an increase in the number of seizures (fits) whilst taking this medicine. If this happens to you, or to your child, contact your doctor immediately.

Talk to your doctor immediately if you experience:

Very common side effects (may affect more than 1 in 10 people)

•    Visual field changes- About K or 33 out of 100 patients treated with Sabril may have changes in the visual field (narrow visual field). This “visual field defect” can range from mild to severe. It is usually detected after months or years of treatment with Sabril. The changes in the visual field may be irreversible, so it must be found early. If you or your child experience(s) visual disturbances, contact your doctor or hospital immediately.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people)

•    Tiredness and pronounced sleepiness

•    Joint pain

Common side effects (may affect up to 1 in 10 people)

•    Headache

•    Weight gain

•    Shaking (tremor)

•    Swelling (oedema)

•    Dizziness

•    Sensation of numbness or tingling (pins and needles)

•    Disturbance of concentration and memory

•    Psychological disturbances including agitation, aggression, nervousness, irritability, depression, thought disturbance and feeling suspicious without reason (paranoia). These side effects are usually reversible when the dose is reduced or gradually discontinued. However, do not decrease your dose without first talking to your doctor. Contact your doctor if you experience these side effects.

•    Nausea, Vomiting and abdominal pain

•    Blurred vision, double vision, and uncontrolled movement of the eye, which may cause dizziness

•    Speech disorder

•    Decrease in the number of red blood cell count (anaemia)

Uncommon side effects (may affect up to 1 in 100 people)

•    Lack of coordination in movements or fumbling

•    More severe psychological disturbances such as feeling elated or over-excited which causes unusual behaviour, and feeling detached from reality

•    Skin rash

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Rare side effects (may affect up to 1 in 1.000 people)

•    Serious allergic reaction, which causes swelling of the face or throat: If you experience these symptoms, you should tell your doctor immediately.

•    Hives or nettle rash

•    Marked sedation, stupor and confusion. These side effects are usually reversible when the dose is reduced or gradually discontinued. However, do not decrease your dose without first talking to your doctor. Contact your doctor if you experience these side effects.

•    Suicide attempt

•    Other eye problems such as retinal disorder, for example poor vision at night and difficulty adjusting from bright to dim areas, sudden or unexplained loss of vision, loss of sight from the edges of your field of vision, sensitivity to light.

Very rare side effects (may affect up to 1 in 10,000 people)

•    Other eye problems such as pain in your eyes (optic neuritis) and loss of vision, including colour vision (optic atrophy)

•    Hallucinations (feeling, seeing or hearing things that are not there)

•    Liver problems

Additional side effects in children

Very common side effects (may affect more than 1 in 10

people)

•    Excitation or restless

Not known frequency (frequency cannot be estimated from the available data)

Movement disorders in young infants treated for infantile spasm.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

United Kingdom

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Malta

ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D’Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sabril

PLIAGE

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer cardboard box and blisters. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via waste or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the enviornment.

6. Contents of the pack and other information

What Sabril contains

-    The active substance is vigabatrin. One film-coated tablet contains 500 mg vigabatrin.

-    The other ingredients are:

Tablet Core:

Povidone K30 (E1201), Microcrystalline cellulose (E460), Sodium starch glycollate (type A) Magnesium stearate Tablet Coating:

Hypromellose 15 mPa s (E464), Titanium dioxide (E171), Macrogol 8000

What Sabril looks like and contents of the pack

Sabril appears as white to off-white, oval, biconvex film-coated tablets with a break-line on one side and “SABRIL” engraved on the other side.

It is available in clear blisters or opaque blisters of 10 tablets. Each package contains 30, 50, 60, 100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MA Holder:

Sanofi,

One Onslow Street,

Guildford, Surrey,

GU1 4YS, UK.

Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com

Manufactured by:

Patheon France SA,

Boulevard de Champaret,

38300 Bourgoin-Jallieu, France

For any information about this medicine, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Sabril 500 mg Filmtabletten Belgium: Sabril 500 mg filmomhulde tabletten Denmark: Sabrilex

Finland: Sabrilex 500 mg tabletti, kalvopaallysteinen

France: Sabril 500 mg comprime pellicule

Germany: Sabril 500 mg Filmtabletten

Greece: Sabril 500 mg eniKaAuppeva pe AenTo upevio Siaraa

Ireland: Sabril 500 mg film-coated tablets

Italy: Sabril 500 mg compresse rivestite con film

Luxembourg: Sabril 500 mg comprimes pellicules

Netherlands: Sabril 500 mg filmomhulde tablet

Portugal: Sabril 500 mg comprimidos revestidos por

pelicula

Spain: Sabrilex 500 mg comprimidos recubiertos con pelicula

Sweden: Sabrilex 500 mg filmdragerade tabletter United Kingdom: Sabril 500 mg film-coated tablets

This leaflet was last approved in July 2014

7062010