Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The name of your medicine is Sabril Sachets. Each sachet contains a white to off-white granular powder which is made up of 500 mg of the active ingredient vigabatrin and an inactive ingredient, polyvinylpyrrolidone.

Each pack contains 50 sachets.

Sabril Sachets are used to help control epilepsy.

The product licence for Sabril Sachets is held by Marion Merrell Ltd, Broadwater Park, Denham Uxbridge, Middlesex UB9 5HP.

The manufacturer of Sabril Sachets is Marion Merrell SA, Boulevard de Champarey 38317 Bourgoin-Jallieu, France.

Sabril Sachets are used to help control various forms of epilepsy.

Do not take Sabril Sachets if you know you are allergic to vigabatrin.

Tell your doctor immediately if you are pregnant or if you become pregnant during your treatment.

You should also tell your doctor if:

• You are breast feeding
• You have had any psychiatric or nervous illness in the past
• You have had any kidney problems.
• Your doctor may wish to carry out tests on your nervous system to monitor your condition.

You should also tell your doctor if you are taking any other medicines, in particular phenytoin - another drug used in the treatment of epilepsy.

Sabril sometimes causes drowsiness. If you do feel drowsy whilst taking these sachets, you should not do any hazardous tasks such as driving or operating machinery.

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

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 tumbler full of cold water or soft drink. When all the powder has dissolved, drink all of the solution straightaway and do not leave it standing.

The usual starting dose for adults is 2 sachets daily. However, your doctor may wish to increase or decrease the dose depending on your response.

Also if you are elderly and have kidney problems your doctor may wish to give you a smaller dose.

The usual starting dose for children is 40 milligrams per kilogram bodyweight daily. However, the doctor may wish to increase the dose to 80-100 milligrams per kilogram bodyweight daily depending on the child's response.

The following table gives the number of Sabril Sachets to give to a child according to his/her bodyweight. Remember, this is just a guideline. The child's doctor may wish to give slightly different doses.

Bodyweight 10-15 kg 1-2 sachets/day

15-30 kg 2-3 sachets/day

30-50 kg 3-6 sachets/day

greater than 50 kg 4-8 sachets/day (adult dose)

kilogram bodyweight per day although higher doses may be used sometimes.

If you or your child accidentally take too much Sabril, tell your doctor immediately or go to your nearest casualty department.

If you forget to take a dose take another as soon as you remember, unless it is almost time for your next dose, then go on as before.

This medicine sometimes causes side-effects.

If you develop any of the following you should tell your doctor:

• psychological disturbances including agitation, nervousness, aggression, irritability and depression. Rarely, more severe disturbance of this type can occur.
• drowsiness, tiredness, dizziness or confusion. If these become severe you should tell your doctor immediately.
• headache
• memory disturbances, impaired concentration
• pins and needles, tremor or difficulty balancing
• vision complaints
• weight gain
• stomach upset
• unexpected swelling of parts of the body
• hair loss
• skin rash
• children may become over excited or restless.

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

You should also tell your doctor or pharmacist if you notice any other unusual effect not mentioned above.

Do not use your medicine after the expiry date shown on the box.

If your doctor decides to stop your treatment, return any leftover sachets to your pharmacist. Only keep them if your doctor tells you to.

Keep the sachets in a safe place unopened and out of the reach of children.

Date of preparation: February 1996

The following centres can provide additional information on epilepsy:

British Epilepsy Association

Anstey House

40 Hanover Square

Leeds LS3 1 BE

Tel: 0113 2439393

Helpline: 0800 309030

Chalfont Centre for Epilepsy

Chalfont St Peter

Gerrards Cross

Bucks SL9 0RJ

Tel: 01494 873991

Information line: 01494 872049

Epilepsy Association of Scotland

48 Govan Road

Glasgow G51 1JL

Tel: 0141 427 4911

Wales Epilepsy Association

Y Pant Teg

Brynteg

Dolgellau

Gwynedd LL40 1RP

Tel: 01341 423339 continued

Northern Ireland Office

Old Postgraduate Centre

Belfast City Hospital

Lisburn Road

Belfast BT9 7AB

249 Crumlin Road

Dublin 12