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SABRIL 500 MG FILM-COATED TABLETS

Active substance(s): VIGABATRIN

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Sabril® 500 mg film-coated tablets
(vigabatrin)

2999
03.03.17[2]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- 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.
This medicine is available using the above name but will be referred to as
Sabril throughout this leaflet.
What is in this leaflet:
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
1. 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SABRIL
Do not take Sabril:
- if you are allergic to vigabatrin or any of the other ingredients of this
medicine (listed in Section 6).
Warnings and precautions
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 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.
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 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.
Other medicines and Sabril
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.
Pregnancy, breast-feeding and fertility
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.

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.
3. HOW TO TAKE SABRIL
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
15 - 30 kg
30 - 50 kg
greater than 50 kg

0.5-1 g (1-2 tablets)/day
1-1.5 g (2-3 tablets)/day
1.5-3 g (3-6 tablets)/day
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.

4. 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.

5. HOW TO STORE SABRIL
Keep out of the sight and reach of children.

Talk to your doctor immediately if you experience:

Do not store above 25°C.

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.

If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.

Other side effects include:
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). 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)

Do not use this medicine after the expiry date which is stated on the carton
and the blister after EXP. The expiry date refers to the last day of that
month.

Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Sabril contains
- The active substance is vigabatrin.
- Each tablet contains 500 mg of vigabatrin.
- The other ingredients are: microcrystalline cellulose, povidone, sodium
starch glycollate, magnesium stearate, hypromellose, titanium dioxide and
macrogol 8000.
What Sabril looks like and contents of the pack
white to off-white, oval, biconvex film-coated tablets with a break-line on one
side and “SABRIL” engraved on the other side.
Sabril is available in blister packs of 50 or 100 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Sabril is manufactured by Patheon France, Bourgoin-Jallieu, France.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2999

Leaflet revision and issue date (Ref) 03.03.17[2]
Sabril is a trademark of Aventisub LLC.

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 overexcited 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the leaflet
in a format suitable for you.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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