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SABRIL 500MG GRANULES FOR ORAL SOLUTION

Active substance(s): VIGABATRIN

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Package leaflet:
Information for the user

®

Sabril 500mg granules for
oral solution
(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 granules
for oral solution but will be referred to as Sabril
throughout this leaflet.

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
patients.

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

The usual starting dose for adults is 1g (2 sachets)
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 sachets). The
highest recommended dose is 3g/day.

1. What Sabril is and what it is used
for

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 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.

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 breastfeeding, ask your doctor for advice before taking this
medicine. Breast-feeding should not be done during
treatment.

If you are older people and/or have kidney problems,
your doctor may wish to give you a smaller dose.

Bodyweight 10-15kg
15-30kg
30-50kg
greater than 50kg

0.5-1g (1-2 sachets)/day
1-1.5g (2-3 sachets)/day
1.5-3g (3-6 sachets)/day
2-3g (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 take more Sabril than you should
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 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 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
(anaemia)
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
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
any 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.
This medicine does not require any special
storage conditions.
Do not take the granules after the expiry date
which is stated on the carton and sachet label
after ‘Exp’. The expiry date refers to the last day
of that month.
If the granules become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Sabril contains
The active ingredient in the Sabril is vigabatrin.
Each sachet contains 500mg vigabatrin.
The other ingredient is: povidone k30 (E1201).
What Sabril looks like and contents of the pack
Sabril appears as white to off-white granular powder.
It is available in packs of 50 sachets.
Manufactured by: PATHEON FRANCE S.A.S.
40, Boulevard de Champaret – 38317 BourgoinJallieu, 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 granules for oral solution:
PL 18799/2971
POM
Leaflet date: 03.10.2016
Sabril is the registered trademark of Sanofi.

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