Sabril (Vigabatrin)

Sabril 500 mg granules for oral solution. Vigabatrin

WHAT SABRIL IS AND WHAT IT IS USED FOR

Sabril is used to help control various forms of epilepsy.

It 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.

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

BEFORE YOU TAKE SABRIL

Do not take Sabril

if you are allergic (hypersensitive) to vigabatrin or any of the other ingredients of Sabril.

Take special care with Sabril

You should tell your doctor if:

• You are breast feeding
• 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 kidney problems
• 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.

Movement disorders have been reported in young infants treated for infantile spasms (West syndrome). If you observe unusual movement disorders in the child, consult the doctor who will decide if it is necessary to consider changing 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 anti-epileptics such as vigabatrin have had thoughts of harming or killing themselves. If at any time you have had these thoughts, immediately contact your doctor.

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Sabril should not be used in combination with other medicines that may have side effects related to the eye.

Pregnancy and breast-feeding

If you are planning to become pregnant, you should talk to your doctor before taking your medicine. Do not take Sabril during pregnancy unless your doctor tells you to. Sabril may cause problems to unborn children. Tell your doctor immediately if you are pregnant or if you become pregnant during your treatment. However, do not stop taking the medicine suddenly because this may risk the mother’s health as well as the baby’s health.

Sabril can be found in breast milk. Therefore, breastfeeding is not recommended during treatment.

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.

HOW TO TAKE SABRIL

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 patients.

Do not open the sachets until it is time for you to take your medicine. To take a dose you should dissolve all the powder from the recommended number of sachets in half a drinking glass full of cold water or soft drink, like juice or milk. When all the powder has dissolved, drink all of the solution straight away and do not leave it standing.

You can take Sabril before or after meals. The usual starting dose for adults is 1 g (2 sachets) 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 sachets). 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 bodyweight daily. The following table gives the number of sachets 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 slightly different doses.

Bodyweight10-15 kg	1-2 sachets/day
15-30 kg	2-3 sachets/day
30-50 kg	3-6 sachets/day
greater than 50 kg	4-6 sachets/day (adult dose).

The recommended starting dose tor infants with West’s Syndrome (infantile spasms) is 50 milligrams per kilogram bodyweight per day although higher doses may be used sometimes.

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

If you take more Sabril than you should

If you or your child accidentally take too many Sabril sachets, 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.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Sabril 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.

Very common side effects

These side effects affect more than 1 patient in every 10 patients treated.

About 1/3 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.

Common side effects

These side effects affect between 1 and 10 patients in every 100 patients treated.

• 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). 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 effects.
• Nausea and abdominal pain
• Blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness
• Speech disorder

Uncommon side effects

These side effects affect between 1 and 10 patients in every 1000 patients treated.

• 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

Rare side effects

These side effects affect between 1 and 10 patients in every 10,000 patients treated.

• 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 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

These side effects affect less than 1 patient in every 10,000 patients treated.

• 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

Unknown side effects

Movement disorders in young infants treated for infantile spasm

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE SABRIL

Keep out of the reach and sight of children. Do not use Sabril after the expiry date which is stated on the outer cardboard box and sachets. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Sabril contains

The active substance isvigabatrin. One sachet contains 500 mgvigabatrin.

The other ingredient is: Povidone K30 (E1201)

What Sabril looks like and contents of the pack

Sabril appears as white to off-white granular powder.

It is available in packs of 50, 60 or 100 sachets. Not all pack sizes may be marketed.