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SABRIL 500MG TABLETS

Active substance(s): VIGABATRIN

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Package leaflet:
Information for the user
®

SABRIL 500mg Tablets
(vigabatrin)
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.
The name of your medicine is SABRIL 500mg Tablets but it
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. Before you take Sabril

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. Breastfeeding 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
Do not take Sabril

x 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 anti-epileptics
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.

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 1g (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 3g (4 to 6 tablets). The highest recommended dose is
3g/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 40milligrams 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 10-15kg
15-30kg
30-50kg
greater than 50kg

0.5-1g (1-2 tablets)/day
1-1.5g (2-3 tablets)/day
1.5-3g (3-6 tablets)/day
2-3g (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 50milligrams 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, 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.
Talk to your doctor immediately if you experience:
Very common side effects (may affect more than 1 in 10
people)
Visual field changes - About 1/3 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, 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.

5. How to store Sabril
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use your medicine after the expiry date shown on the
box.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of
deterioration, show them to a pharmacist who will advise you
what to do.

6. Contents of the pack and other information
What Sabril contains
Each film-coated tablet contains 500mg of vigabatrin as the
active ingredient.
They also contain povidone, microcrystalline cellulose,
sodium starch glycollate, magnesium stearate,
hydroxypropyl methylcellulose, titanium dioxide (E171) and
polyethylene glycol 8000.
What Sabril looks like and contents of the pack
The tablets are white, oval, film-coated tablets marked with
„sabril‟ on one side and a score line on the other side.
Each pack contains 30 tablets.
Manufactured by: Patheon France S.A., 40 Boulevard de
Champaret, 38300 Bourgoin-Jallieu, France.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Sabril 500mg Tablets ; PL No: 18799/0782
Leaflet date: 12.05.2015
Sabril is a registered trademark of Sanofi-Aventis group of
companies.

POM

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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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