SABRILEX 500 mg FILM-COATED TABLETS

2. What you need to know before you take Sabrilex

Do not take Sabrilex

• 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 starting Sabrilex if:

• you are breastfeeding
• you are pregnant or planning to become pregnant
• you have had depression or any other psychiatric disorder in the past
• you have had kidney problems
• you have had eye problems.

If you develop symptoms such as drowsiness, decreased consciousness and movement (stupor) or confusion, consult your doctor, who will decide whether to reduce the dose or stop treatment.

A small number of people being treated with antiepileptics such as vigabatrin have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.

Children

Motor disorders have been reported in children treated for infantile spasms (West syndrome). If you observe unusual movement disorders in the child, consult your doctor, who will decide whether to consider changing treatment.

Taking Sabrilex with other medicines

Please inform your doctor if you are taking clonazepam, as its use in combination with Sabrilex may increase the risk of sedation.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Sabrilex should not be taken in combination with other medicines that may have adverse effects on the eyes.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not take Sabrilex during pregnancy unless your doctor tells you to. Sabrilex may cause problems for the fetus. However, do not stop treatment abruptly, as this may endanger the health of the mother and the baby.

Sabrilex passes into breast milk. If you are breastfeeding, ask your doctor before using this medicine. You should not breastfeed during treatment.

Driving and using machines

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

Sabrilex can sometimes cause symptoms such as drowsiness or dizziness, and your ability to concentrate and react may be impaired. If these symptoms appear during your treatment with Sabrilex, you should not perform any hazardous tasks such as driving or operating machinery.

Visual disturbances, which can affect your ability to drive or operate machinery, have occurred in some patients taking this medicine. If you want to continue driving, you should be examined regularly (every six months) to rule out visual disturbances, even if you do not notice any changes in your vision.

Sabrilex contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Sabrilex

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor again.

It is important to follow your doctor's instructions exactly. Never change the dose.

The doctor prescribes the dose and adjusts it individually for patients. The recommended dose for starting treatment is 1 g (2 tablets) per day. However, your doctor may increase or decrease the dose depending on your response to treatment; the normal daily dose for adults is 2 to 3 g (4 to 6 tablets). The highest recommended dose is 3 g per day.

If you are an elderly patient and/or have kidney problems, your doctor will prescribe a lower dose.

Use in children

Resistant partial epilepsy

In children, the dose is based on age and weight. The recommended dose for starting treatment is 40 milligrams per kilogram of body weight per day. The following table indicates the number of tablets to be administered to children depending on their body weight. Remember that this is only a guide. The child's doctor will decide whether to prescribe a slightly different dose.

Weight 10-15 kg 0.5-1 g (1-2 tablets)/day

15-30 kg 1-1.5 g (2-3 tablets)/day

30-50 kg 1.5-3 g (3-6 tablets)/day

More than 50 kg 2-3 g (4-6 tablets)/day (adult dose).

Children with infantile spasms (West syndrome)

The recommended starting dose for infants with West syndrome (infantile spasms) is 50 milligrams per kilogram of body weight per day, although sometimes higher doses may be administered.

Method of administration

The route of administration is oral (by mouth).

Always swallow the tablet with at least half a glass of water.

Sabrilex can be taken before or after meals.

The daily dose can be taken as a single dose or divided into two doses.

If you take more Sabrilex than you should

If you or your child accidentally take too many Sabrilex tablets, consult your doctor immediately or go to the emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken.

Possible symptoms of overdose include drowsiness or loss/decreased level of consciousness.

If you forget to take Sabrilex

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, take only one dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Sabrilex

Do not stop taking this medicine without consulting your doctor. If your doctor decides to stop your treatment, they will give you recommendations on how to gradually reduce the dose. Do not stop it abruptly, as this may cause your seizures to return.

If you have any other questions about 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 (convulsions) while taking this medicine. If this happens to you or your child, contact your doctor immediately.

Tell your doctor immediately if you experience:

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

• Changes in the visual field - About 1/3 or 33% of patients treated with Sabrilex may have changes in the visual field (narrowing of the visual field). This "visual field defect" can be mild to severe. These are usually detected after months or years of treatment with Sabrilex. Visual field changes can be irreversible, so they must be detected early. If you or your child experience any visual disturbances, contact your doctor or hospital immediately.

Other side effects include:

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

• Fatigue and increased drowsiness
• Joint pain.

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

• Headache
• Weight gain
• Tremor
• Swelling (edema)
• Dizziness
• Feeling of numbness or tingling
• Concentration and memory disorders
• Psychological disorders, including agitation, aggression, nervousness, irritability, depression, thought disorders, and paranoid reaction (progressive mental disorder), insomnia. These side effects are generally reversible with dose reduction or gradual discontinuation of treatment. However, do not reduce your dose without consulting your doctor first. Contact your doctor if you experience these side effects.
• Nausea, vomiting, and abdominal pain
• Blurred vision, double vision, and rapid involuntary eye movements
• Speech disorders
• Decreased red blood cell count (anemia)
• Unusual hair loss or weakened hair (alopecia).

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

• Lack of coordination, clumsiness
• More severe psychological disorders such as hypomania, mania, and psychosis
• Skin rash.

Rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction, which causes swelling of the face or throat. If you experience any of these symptoms, tell your doctor immediately.
• Hives

• Marked sedation, stupor, and confusion. These side effects are usually reversible with dose reduction or gradual discontinuation of treatment. However, do not reduce your dose without consulting your doctor first. Contact your doctor if you experience these side effects.

• Suicidal attempt
• Other eye disorders such as retinal disorder.

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

• Other eye disorders such as optic neuritis and optic atrophy
• Hallucinations
• Liver disorders.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Decreased visual acuity
• Abnormal changes in brain images taken by magnetic resonance imaging
• Swelling in the protective layer of nerve cells in part of the brain as seen in magnetic resonance images.

Other side effects in children

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

• Excitement or restlessness.

Side effects of unknown frequency (cannot be estimated from available data)

• Movement disorders in children treated for infantile spasms
• Abnormal changes in brain images taken by magnetic resonance imaging, particularly in infants
• Swelling in the protective layer of nerve cells in part of the brain as seen in magnetic resonance images.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sabrilex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister packs. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sabrilex

• The active ingredient is vigabatrin. Each film-coated tablet contains 500 mg of vigabatrin.
• The other ingredients are:

Core of the tablet:

Povidone K30 (E1201), Microcrystalline cellulose (E460), Sodium starch glycolate (type A), Magnesium stearate.

Coating of the tablet:

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

Appearance of the product and pack contents

Sabrilex film-coated tablets are white or almost white, oval, biconvex, with a score line on one side and Sabrilex engraved on the other side.

They are available in transparent or opaque blisters of 10 tablets.

Each pack contains 30, 50, 60, 100, or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

The manufacturer is:

Patheon France

Boulevard de Champaret

38300 Bourgoin-Jallieu (France)

Or

Sanofi-Aventis Deutschland GmbH

Industriepark Hoechst-Brueningstrase 50

65926 Frankfurt am Main (Germany)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria:Sabril 500 mg Filmtabletten

Belgium:Sabril 500 mg filmomhulde tabletten

Denmark: Sabrilex

Finland:Sabrilex 500 mg tabletti, kalvopäällysteinen

France: Sabril 500 mg comprimé pelliculé

Germany:Sabril 500 mg Filmtabletten

Greece:Sabril 500 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Ireland:Sabril 500 mg film-coated tablets

Italy:Sabril 500 mg compresse rivestite con film

Luxembourg: Sabril 500 mg comprimés pelliculés

Netherlands:Sabril 500 mg filmomhulde tablet

Portugal: Sabril 500 mg comprimidos revestidos por pelicula

Spain:Sabrilex 500 mg comprimidos recubiertos con película

Sweden:Sabrilex 500 mg filmdragerade tabletter

United Kingdom:Sabril 500 mg film-coated tablets

Date of last revision of this leaflet: January 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/