Leaflet: information for the user

Sabrilex 500 mg film-coated tablets

Vigabatrin

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Sabrilex is and what it is used for

2. What you need to know before you start taking Sabrilex

3. How to take Sabrilex

4. Possible side effects

5. Storage of Sabrilex

6. Contents of the pack and additional informationadditional information

Sabrilex is used to help control various forms of epilepsy.

It is used in conjunction with your current medication to treat "difficult to control" epilepsy. It will initially be prescribed by a specialist. Your response to treatment will be monitored.

It is also used to control infantile spasms (West syndrome).

Do not take Sabrilex

-If you are allergicto vigabatrin, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Sabrilex if:

• You are breastfeeding
• You are pregnant or plan to become pregnant
• You have or have had depression or any other psychiatric illness in the past
• You have had any problems with your kidneys
• You have had any problems with your eyes.

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 antiepileptic drugs such as vigabatrin have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.

Children

There have been reports of movement disorders 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 medications

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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Sabrilex should not be taken in combination with other medications that may have adverse effects related to 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 medication. 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 put the mother's and baby's health at risk.

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

Driving and operating machinery

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

Sabrilex may 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 may affect your ability to drive or operate machinery, have appeared in some patients taking this medication. If you wish to continue driving, you must be examined regularly (every six months) to rule out the presence of visual disturbances, even if you do not notice any change in your vision.

Sabrilex contains sodium

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

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

It is essential to follow exactly the instructions of your doctor. Never change the dose.

Your doctor prescribes the dose and adjusts it individually for patients. The recommended starting dose is1 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 is2 to3 g(from4 to6 tablets). The highest recommended dose is3 gper 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

Inchildrenthe dose is based on age and weight. The recommended starting dose 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.

Weight10-15 kg0.5-1 g(1-2 tablets)/day

15-30 kg1-1.5 g(2-3 tablets)/day

30-50 kg1.5-3 g(3-6 tablets)/day

More than50 kg2-3 g(4-6 tablets)/day (adult dose).

Infants 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 higher doses may be administered in some cases.

Method of administration

The administration route is oral (by mouth).

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 nearest hospital emergency department, accompanied by this leaflet or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount taken.

The possible symptoms of overdose include drowsiness or loss/disruption 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 to take the next dose, only take one dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sabrilex

Do not stop taking this medication without consulting your doctor. If your doctor decides to stop your treatment, they will give you recommendations on how to gradually reducethe dose. Do notstop it abruptly as this may cause your seizures to recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Like 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.

Inform your doctor immediately if you experience:

Frequent side effects (may affect more than 1 in 10 patients)

• Changes in the visual field - Approximately 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 may be irreversible, so they must be detected early. If you or your child experience any visual disturbance, contact your doctor or hospital immediately.

Other side effects include:

Frequent side effects (may affect more than 1 in 10 patients)

• Fatigue and increased somnolence
• Joint pain.

Frequent side effects (may affect up to 1 in 10 patients)

• Headache
• Weight gain
• Tremor
• Swelling (edema)
• Dizziness
• Sensation of numbness or tingling
• Cognitive and memory disturbances
• Psychological disturbances, 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 involuntary rapid eye movements
• Speech disturbances
• Decreased red blood cell count (anemia)
• Unusual hair loss or weakened hair (alopecia).

Rare side effects (may affect up to 1 in 100 patients)

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

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

• Severe allergic reaction, which causes facial swelling or throat swelling. If you experience any of these symptoms, inform your doctor immediately
• Urticaria

• Marked sedation, stupor, and confusion. These side effects are usually reversible by reducing the dose or gradually discontinuing treatment. However, do not reduce your dose without consulting your doctor first. Contact your doctor if you experience these side effects

• Attempted suicide
• Other eye disorders such as retinal disorder.

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

• 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 imaging images.

Other side effects in children

Frequent side effects (may affect more than 1 in 10 patients)

• 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 imaging images.

Reporting side effects:

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister packs. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sabrilex

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

Tablet core:

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

Film coating:

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

Appearance of the product and contents of the pack

Sabrilex film-coated tablets are white or off-white, oval, biconvex, with a notch on one face and Sabrilex engraved on the other face.

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization 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-Brueningstrasse 50

65926 Frankfurt am Main (Germany)

This medicinal product is authorized in the member states of the European Economic Area with 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 mgepikalyptomeno me lept? um?no diska

Ireland:Sabril 500 mg film-coated tablets

Italy:Sabril 500 mg compresse rivestite con film

Luxembourg:Sabril 500 mg comprimés pelliculés

Netherlands:Sabril 500mg filmomhulde tablet

Portugal:Sabril 500 mgcomprimidos revestidos por pelicula

Spain:Sabrilex 500 mg comprimidos recubiertos con película

Sweden:Sabrilex 500 mg filmdragerade tabletter

United Kingdom:Sabril500 mg film-coated tablets

Last review date of this leaflet: January 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/