Sabril 500 mg Film-Coated Tablets

SABRIL is used to help control various forms of epilepsy. SABRIL is used together with your current medication to treat “difficult to control” epilepsy. It will initially be prescribed by a specialist. Your response to the treatment will be monitored.

Do not take SABRIL:

• If you are allergic (hypersensitive) to vigabatrin or any of the other ingredients of SABRIL.
• If you are breastfeeding.
• If you may be pregnant, are pregnant or plan to become pregnant.
• If you have severe kidney problems.

Warnings and precautions

You should tell your doctor:

• If you have or have had depression or any other psychiatric illness in the past.
• If you have any other kidney problems.
• If you have had any problems with your eyes.
• If you are using any medicines that may have side effects related to the eye (retinotoxic medicines).
• If you are taking a medicine called clonazepam used to treat seizures, panic disorder or anxiety disorders (see Other medicines and SABRIL).

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

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 of SABRIL.

Movement disorders and abnormalities in magnetic resonance imaging (MRI) brain scans have been seen, especially 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

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Please tell your doctor if you are taking clonazepam as the concomitant use with SABRIL can increase the risk of sedation.

Do not share medicines prescribed for you with any other person. It is important to follow your doctor’s instructions exactly. Never change the dose yourself. The doctor prescribes the dosage and adjusts it individually for the patients. Always swallow the tablet with at least a half of a drinking glass of water.

The usual starting dose for adults is 2 tablets daily. However, your doctor may wish to increase or decrease the dose depending on your response; the usual adult daily dose is 2 to 3 g (4 to 6 tablets). The highest recommended dose is 3 g/day. Also, if you are elderly and/or have kidney problems, your doctor may wish to give you a smaller dose.

For children, the dose is based on age and weight. The usual starting dose for children is 40 milligrams per kilogram body weight daily. The following table gives the number of SABRIL tablets to give to a child according to his/her bodyweight. Remember that this is just a guideline. The child’s doctor may wish to have a slightly different dose.

Body weight

• 10 – 15 kg: 1 – 2 tablets/day (0.5 – 1 g/day)
• 15 – 30 kg: 2 – 3 tablets/day (1 – 1.5 g/day)
• 30 – 50 kg: 3 – 6 tablets/day (1.5 – 3 g/day)
• greater than 50 kg: 4 – 6 tablets/day (2 – 3 g/day (adult dose))

The daily dose can be taken as a single dose or divided in two doses. You must see your doctor if your symptoms worsen or do not improve after 10 days.

If you have the impression that the effect of SABRIL is too strong or too weak, tell your doctor or pharmacist.

If you take more SABRIL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison 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 forgotten individual doses.

If you stop taking SABRIL: Do not stop taking SABRIL 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.

SABRIL can have side effects. Not all side effects reported for SABRIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SABRIL, please consult your health care provider for advice.

Some patients may experience an increase in the number of seizures (fits) whilst taking SABRIL. If this happens to you, or to your child, contact your doctor immediately.

If any of the following happens, stop taking SABRIL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting
• Yellowing of the skin and eyes, also called jaundice

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SABRIL. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• About one third 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.
• Children may become over excited or restless
• Tiredness and pronounced sleepiness
• Joint pain
• Headache
• Weight gain
• Tremor
• Oedema (swelling)
• 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), insomnia. These side effects are usually reversible when SABRIL doses are reduced or gradually discontinued. However, do not decrease your dose without first talking to your doctor. Contact your doctor if you experience these effects.
• Nausea, vomiting and abdominal pain
• Blurred vision, double vision, and rapid involuntary movement of the eye, which may cause dizziness
• Speech disorder
• Decrease in the number of red blood cell (anaemia)
• Unusual hair loss or thinning (alopecia)

Less frequent side effects:

• Lack of coordination in movements or fumbling
• Skin rash
• More severe psychological disturbances such as feeling elated or over-excited which causes unusual behaviour and feeling detached from reality.
• 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.
• Marked sedation, stupor and confusion. These side effects are usually reversible when SABRIL doses are reduced or gradually discontinued. However, do not decrease your dose without first talking to your doctor. Contact your doctor if you experience these effects.
• Hallucinations (feeling, seeing or hearing things that are not there)
• Other eye problems such as pain in your eyes (optic neuritis) and loss of vision, including colour vision (optic atrophy)
• Liver problems

Side effects where the frequency is unknown:

• Abnormal changes in brain pictures taken by magnetic resonance imaging (MRI)
• Swelling of part of the brain, particularly in infants

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to:

• The Pharmacovigilance Unit at Sanofi: [email protected] (email) or 011 256-3700 (tel), or
• SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of SABRIL.

Store at or below 30 C°. Store in the original container. Do not use after the expiry date stated on the carton and blisters. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.