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SABRIL 500MG FILM-COATED TABLETS

Active substance(s): VIGABATRIN

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Ref: 1634/280416/1/F

Sabril 500mg film-coated tablets
(vigabatrin)
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.
Your medicine is called Sabril 500mg film-coated tablets but will be referred
to as Sabril throughout the 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

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.
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

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 infant 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.

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.

Ref: 1634/280416/1/B

Sabril 500mg film-coated tablets
(vigabatrin)
Patient Information Leaflet (continued)
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.
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
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)
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 or pharmacist.This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.
5

How to store Sabril

Keep out of the sight and reach of children.
Do not use Sabril after the expiry date which is stated on the
blisters or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
This medicine does not require any special storage conditions.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
6

Contents of the pack and other information

What Sabril contains:
Each tablet contains 500mg of vigabatrin
Other ingredients are Povidone K30 (E1201), Microcrystalline cellulose
(E460), Sodium starch glycollate (type A) Magnesium stearate,
Hypromellose 15 mPa.s (E464), Titanium dioxide (E171), Macrogol 8000
What Sabril look like and contents of the pack
Sabril is a film-coated tablet which is a white to off-white, oval, biconvex,
tablet with a break-line on one side and “Sabril” engraved on the other side.
Each pack contains 100 Tablets.
Manufacturer and Licence Holder
Manufactured by Patheon France S.A.S, 40 Boulevard De Champaret,
Bourgoin-Jallieu F-38317, France’. and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.
PL 15184/1634

Sabril 500mg film-coated tablets

POM
Sabril is a registered trademark of Sanofi
Revision date: 28/04/16

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Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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