Sabril 500 mg granules for oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to vigabatrin or any of the other ingredients of this medicine (listed in Section 6).

Talk to your doctor before taking Sabril 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, 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.

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 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.

Bodyweight 10-15 kg 0.5-1 g (1-2 sachets)/day

15-30 kg 1-1.5 g (2-3 sachets)/day

30-50 kg 1.5-3 g (3-6 sachets)/day

greater than 50 kg 2-3 g (4-6 sachets)/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).

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

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 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.

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.

Very common side effects (may affect more than 1 in 10 people)

• Tiredness and pronounced sleepiness.
• Joint pain

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 affects 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

Not known frequency (frequency cannot be estimated from the available data)

• Decreased sharpness of vision
• Abnormal changes in brain pictures taken by MRI
• Swelling in the protective layer of nerve cells in part of the brain as observed in MRI pictures

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.
• Abnormal changes in brain pictures taken by MRI, particularly in infants
• Swelling in the protective layer of nerve cells in part of the brain as observed in MRI pictures, particularly in infants

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 via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is vigabatrin. One sachet contains 500 mg vigabatrin.
• The other ingredient is: Povidone K30 (E1201)

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.

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