Sabril Powder

What Sabril Powder 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).

How to take Sabril Powder

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 Ver1 CCDS ver 12 and Yellow card wording+ assessors commnet 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 take more Sabril than you should 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 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, 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)
• Visual field changes – About ⅓ 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.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people)
• Tiredness and pronounced sleepiness
• Joint pain Ver1 CCDS ver 12 and Yellow card wording+ assessors commnet

Common side effects (may affect up to 1 in 10 people)
• Headache
• Weight gain
• Shaking (tremor)
• Swelling (oedema)
• 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 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 side effects.
• Nausea, Vomiting and abdominal pain
• Blurred vision, double vision, and uncontrolled movement of the eye, which may cause dizziness
• Speech disorder
• Decrease in the number of red blood cell count (anaemia)
• Unusual hair loss or thinning (alopecia)

Uncommon side effects (may affect up to 1 in 100 people)
• 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 (may affect up to 1 in 1.000 people)
• 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 side 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 (may affect up to 1 in 10,000 people)
• 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 Additional side effects in children

Very common side effects (may affect more than 1 in 10 people)
• Excitation or restless

Not known frequency (frequency cannot be estimated from the available data) Movement disorders in young infants treated for infantile spasm.

Reporting of side effects 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 Ver1 CCDS ver 12 and Yellow card wording+ assessors commnet Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine

How to Store Sabril Powder

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 enviornment.