Consumer Medication Information Leaflet (RiMUP)

SABRIL® TABLET
Vigabatrin (500mg)

What is in this leaflet these thoughts, immediately contact - How much to use
your doctor. Adults
1. What Sabril is used for • The usual starting dose for adults is
2. How Sabril works Check with your doctor or pharmacist 1g (2 tablets) daily. However, your
3. Before you use Sabril before taking your medicine if: doctor may wish to increase or
4. How to use Sabril • You are breast feeding decrease the dose depending on your
5. While you are using it • You are pregnant or plan to become response.
6. Side effects pregnant. • The usual adult daily dose is 2 to 3g
7. Storage and disposal of Sabril • You have or have had depression, (4 to 6 tablets).
8. Product description behavioural disorders or any other • The highest recommended dose is
9. Manufacturer and Product psychiatric illness in the past 3g/day.
Registration Holder • You have had any kidney problems
10. Date of revision • You are an elderly. Children
• You have had any problems with your • Tablets are not suitable for children
What Sabril is used for eyes. under the age of 6 years, because of
Sabril is used to help control various the risk of choking.
form of epilepsy. Sabril is used as an Visual field loss • The usual starting dose for children is
add-on treatment for people whose Loss of sight from the edges of your 40 milligrams per kilogram
epilepsy has not been well controlled field of vision may occur during bodyweight daily.
by, or who cannot take, other treatment with Sabril. You should • Recommendations in relation to
antiepileptic medicines. discuss this possibility with your doctor bodyweight for maintenance
before you begin treatment with this treatment are as follows:
How Sabril works medicine. This visual field loss may be 10-15 kg 1-2 tablets/day
Sabril contains a medicine called severe and irreversible, so it must be 15-30 kg 2-3 tablets/day
vigabatrin. Vigabatrin works by found early. A deterioration of this 30-50 kg 3-6 tablets/day
affecting the activity of a visual field loss after treatment is
>50 kg 4-6 tablets/day.
neurotransmitter called GABA discontinued cannot be excluded. It is
(gamma-aminobutyric acid). important that you inform your doctor
Neurotransmitters are natural body Elderly
promptly if you become aware of any
chemicals that are stored in nerve cells. • If you are elderly and /or have kidney
change to your vision. Your doctor
They are involved in transmitting problems, your doctor may wish to
should perform a Visual field
messages between the nerve cells. give you a smaller dose.
examination before you start taking
GABA is a neurotransmitter that acts as Sabril and at regular intervals during
a natural 'nerve calming' agent. It helps the treatment - When to use it
keep the electrical nerve activity in the Take Sabril at about the same time
brain in balance. If you develop symptoms like each day unless your doctor tells you
Vigabatrin prevents the breakdown of sleepiness, reduced consciousness and otherwise.
GABA in the brain. This enables movements (stupor) or confusion • Swallow the tablets orally with
GABA to calm the nerve activity in the consult your doctor who will decide sufficient amounts of liquid
brain for a longer period of time, which upon a dose reduction or withdrawal. (approximately 1/2 glass). Sabril can
helps to prevent seizures. be taken with or without food.
- Taking other medicines • The daily dose can be taken as a
Before you use Sabril Please tell your doctor or pharmacist if single dose or divided in two doses.
- When you must not use it you are taking or have recently taken
Do not take Sabril if any other medicines, including those - How long to use it
• You are allergic (hypersensitive) to obtained without a prescription. Continue taking your medicine for as
vigabatrin or any of the other Sabril should not be used in long as your doctor tells you. Do not
ingredients of Sabril (listed in section combination with other medicines that stop suddenly as this may cause your
8 below). may have side effects related to the seizures to occur again.
eye.
- Before you start to use it - If you forget to use it
A small number of people being treated How to use Sabril If you forget a dose, take it as soon as
with anti-epileptics such as vigabatrin Always take Sabril exactly as your you remember it. However, if it is
have had thoughts of harming or killing doctor has told you. You should check nearly time for the next dose, skip the
themselves. If at any time you have had with your doctor or pharmacist if you missed dose. Do not take a double dose
are not sure. to make up for a forgotten tablet.

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 Consumer Medication Information Leaflet (RiMUP)

- If you use too much (overdose) do any hazardous tasks such as disturbance and feeling suspicious
If you take too many tablets than you driving or operating machinery. without reason (paranoia). These side
should, tell a doctor or go to a hospital • Visual disorders, which can affect effects are usually reversible when
casualty department straight away. your ability to drive and use the dose is reduced or gradually
Take the medicine pack with you. The machines, have been found in some discontinued.
following effects may happen: individual taking this medicine. If • Nausea and abdominal pain
drowsiness, coma, dizziness, headache, you wish to continue driving you • Blurred vision, double vision, and
mental disorder, respiratory depression, must be tested regularly (every six uncontrolled movement of the eye,
slow heartbeat, low blood pressure, months) for the presence of visual which may cause dizziness
agitation, irritability, confusion, disorders even if you do not notice • Speech disorder
behavioural disorder and speech any changes to your vision.
disorder. Uncommon side effects (affect between
Side Effect 1 and 10 individual in every
While you are using it Like all medicines, Sabril can cause 1000 individual treated)
- Things you must do side effects, although not everybody • Lack of coordination in movements or
• Take your medicine exactly as your gets them. fumbling
doctor has told you. Do not be alarmed by this list of • More severe psychological
• Tell all the doctors, dentists and possible side effects. disturbances such as feeling elated or
pharmacists treating you that you are over-excited which causes unusual
taking Sabril. As with other antiepileptic medicines, behaviour, and feeling detached from
• Tell your doctor immediately if you some individual may experience an reality
become pregnant while taking this increase in the number of seizures (fits) • Skin rash
medicine. whilst taking this medicine. If this
• Stop taking Sabril immediately if you happens to you, or to your child, Rare side effects (affect between 1 and
are experiencing any disturbances of contact your doctor immediately. 10 individual in every 10,000
vision. individual treated)
Very common side effects (affects • Serious allergic reaction, which
- Things you must not do more than 1 in 10 people) causes swelling of the face or throat
• About 1/3 or 33 out of 100 individual
Pregnancy and breast-feeding • Hives or nettle rash
• Tell your doctor immediately if you treated with Sabril may have changes
• Marked sedation, stupor and
are pregnant or plan to become in the visual field (narrow visual
confusion. These side effects are
pregnant during your treatment. Do field). This “visual field defect” can
usually reversible when the dose is
not take Sabril during pregnancy range from mild to severe. It is
reduced or gradually discontinued.
usually detected after months or years
unless your doctor tells you to. Sabril • Suicide attempt
of treatment with Sabril. The changes
may cause problems to unborn • Other eye problems such as retinal
children. in the visual field may be irreversible,
disorder, for example poor vision at
• Sabril can be found in breast milk. so it must be found early. If you or
night and difficulty adjusting from
Therefore, breastfeeding is not your child experience(s) visual
bright to dim areas, sudden or
recommended during treatment. disturbances, contact your doctor or
unexplained loss of vision, loss of
• Do not give this medicine to anyone hospital immediately.
sight from the edges of your field of
else, even if they have the same • Children may become over excited or
vision, sensitivity to light.
condition as you. restless.
• Do not use this medicine to treat any • Feeling of lack of energy
If any of the side effects gets serious,
other complaints unless your doctor • Drowsiness
or if you notice any side effects not
tells you to. listed in this leaflet, please tell your
Common side effects (affect between 1
• Do not stop taking Sabril, or change doctor or pharmacist.
and 10 individual in every 100
the dosage, without checking with
individual treated)
your doctor. You may report any side effects or
• Headache
adverse drug reactions directly to the
- Things to be careful of • Weight gain
National Centre for Adverse Drug
• Tremor
Driving and using machines Reaction Monitoring by calling Tel:
• Oedema (swelling)
• Do not drive or operate machinery if • Dizziness
03-78835550, or visiting the website
your epilepsy is uncontrolled. npra.moh.gov.my (Public Reporting
• Sensation of numbness or tingling
• Sabril sometimes causes symptoms (pins and needles)
Medicinal Problems / Side Effects /
like drowsiness or dizziness and your AEFI / Vaccine Safety).
• Disturbance of concentration and
ability to concentrate and react may memory
be reduced. If such symptoms occur • Psychological disturbances including
whilst taking Sabril, you should not agitation, aggression, nervousness,
irritability, depression, thought

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 Consumer Medication Information Leaflet (RiMUP)

Storage and Disposal of Sabril - Product Registration Holder

If you have any queries about any Sanofi-aventis (Malaysia) Sdn. Bhd.
aspect of your medicine, or any Unit TB-18-1,
questions regarding the information in Level 18-1, Tower B, Plaza 33
this leaflet, discuss them with your No.1 Jalan Kemajuan,
doctor or pharmacist. Seksyen 13,
46200 Petaling Jaya,
- Storage Selangor Darul Ehsan,
• Keep out of the reach and sight of Malaysia.
children.
• Do not use Sabril after the expiry date Date of revision
which is stated on the carton. The 6/12/2017
expiry date refers to the last day of
that month. Serial number:
• Store in a cool place below 30°C. NPRA(R4/1)081117/00307

- Disposal
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.

Product Description
- What it looks like
The tablets are white to off-white, oval,
biconvex tablets with a score line on
one side and “SABRIL” engraved on
the other side. The score line makes it
possible to take half a tablet at a time if
the whole tablet is difficult to swallow,
but is not to be used to divide into two
equal doses.

- Ingredients:
Active ingredient:
• The active substance is vigabatrin.
One-filmed coated tablet contains
500mg vigabatrin.
Inactive ingredients:
• The other ingredients are
polyvinylpyrrolidone,
microcrystalline cellulose, Sodium
starch glycolate Ph.Eur., titanium
dioxide, magnesium stearate, purified
water, polyethylene glycol 8000 and
hydroxypropyl methylcellulose.

- MAL number:
MAL19961357AZ

Manufacturer and Product

Registration Holder
- Manufacturer
PATHEON FRANCE S.A.
40, Boulevard de Champaret
38300 Bourgoin-Jallieu, France.