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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0171.
Sabril 500 mg film-coated tablets
Sabril 500 mg film-coated tablets
vigabatrin
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1. What Sabril is and what it is used for
2. What you need to know before you take Sabril
3. How to take Sabril
4. Possible side effects
5. How to store Sabril
6. Contents of the pack and other information
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).
Talk to your doctor before taking Sabril if:
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, up to tunnel vision or loss of vision, 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 and visual acuity testing, before you start taking Sabril and at regular intervals during the treatment.
Sabril may cause reduced vision due to eye problems such as retinal disorder, blurred vision, optic atrophy or optic neuritis (see section 4). If your vision changes consult your ophthalmologist.
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 antiepileptics such as vigabatrin have had thoughts of harming or killing themselves. If at any time you have had these thoughts, immediately contact your doctor.
Children
Movement disorders and abnormalities in magnetic resonance imaging (MRI) brain scans have been seen 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.
Please tell your doctor if your are taking clonazepam as the concomitant use with Sabril can increase the risk of sedation.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Sabril should not be used in combination with other medicines that may have side effects related to the eye.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Do not take Sabril during pregnancy unless your doctor tells you to. Sabril may cause problems to unborn children. However, do not stop taking the medicine suddenly because this may risk the mother’s health as well as the baby’s health.
Sabril passes into breast milk. If you are breast-feeding, ask your doctor for advice before taking this medicine. Breast-feeding should not be done during treatment.
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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
It is important to follow your doctor’s instructions exactly. Never change the dose yourself. The doctor prescribes the dose and adjusts it individually for the patients.
The usual starting dose for adults is 1 g (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.
If you are older people and/or have kidney problems, your doctor may wish to give you a smaller dose.
Use in children
Resistant partial epilepsy
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 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 slightly different doses.
Bodyweight 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
greater than 50 kg 2-3 g (4-6 tablets)/day (adult dose).
Children with infantile spasms (West’s Syndrome)
The recommended starting dose for infants with West’s Syndrome (infantile spasms) is 50 milligrams per kilogram bodyweight per day although higher doses may be used sometimes.
Method of administration
The route of administration is oral use (by mouth).
Always swallow the tablet with at least a half of a drinking glass of water.
You can take Sabril before or after meals.
The daily dose can be taken as a single dose or divided in two doses.
If you or your child accidentally take too many Sabril tablets, 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 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.
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.
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 (fits) whilst taking this medicine. If this happens to you, or to your child, contact your doctor immediately.
Talk to your doctor immediately if you experience:
Very common side effects (may affect more than 1 in 10 people)
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1.000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known frequency (frequency cannot be estimated from the available data)
Very common side effects (may affect more than 1 in 10 people)
Not known frequency (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).
United Kingdom
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Malta
You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer cardboard box and blisters. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via waste or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Sabril appears as white to off-white, oval, biconvex film-coated tablets with a break-line on one side and “SABRIL” engraved on the other side.
It is available in clear blisters or opaque blisters of 10 tablets.
Each package contains 30, 50, 60, 100 or 200 tablets.
Not all pack sizes may be marketed.
MA Holder:
Manufactured by:
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in January 2021.
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