SABRIL 500MG TABLET

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

VIGABATRIN

Disponibil de la:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (nume internaţional):

VIGABATRIN

Unități în pachet:

100Tablet Tablets

Produs de:

PATHEON FRANCE S.A.

Prospect

_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SABRIL
®
TABLET
_ _
Vigabatrin (500mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Sabril is used for
2. How Sabril works
3. Before you use Sabril
4. How to use Sabril
5. While you are using it
6. Side effects
7. Storage and disposal of Sabril
8. Product description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT SABRIL IS USED FOR
Sabril is used to help control various
form of epilepsy. Sabril is used as an
add-on treatment for people whose
epilepsy has not been well controlled
by, or who cannot take, other
antiepileptic medicines.
HOW SABRIL WORKS
Sabril contains a medicine called
vigabatrin. Vigabatrin works by
affecting the activity of a
neurotransmitter called GABA
(gamma-aminobutyric acid).
Neurotransmitters are natural body
chemicals that are stored in nerve cells.
They are involved in transmitting
messages between the nerve cells.
GABA is a neurotransmitter that acts as
a natural 'nerve calming' agent. It helps
keep the electrical nerve activity in the
brain in balance.
Vigabatrin prevents the breakdown of
GABA in the brain. This enables
GABA to calm the nerve activity in the
brain for a longer period of time, which
helps to prevent seizures.
BEFORE YOU USE SABRIL
-
_When you must not use it _
Do not take Sabril if
• You are allergic (hypersensitive) to
vigabatrin or any of the other
ingredients of Sabril (listed in section
8 below).
-
_Before you start to use it _
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.
Check with your doctor or pharmacist
before taking your medicine if:
• You are breast feeding
• You are pregnant or plan to become
pregnant.
• You have or have had depression,
behavioural disorders or any other
psychiatric illness in the past
• You have had any kidney problems
• You are an elderly.
• You have had any problems with your
eyes.
Visua

Caracteristicilor produsului

MY/SAB/0521/CCDSv14
SABRIL 500MG TABLET- DRAFT PACKAGE INSERT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vigabatrin..............................................................................................................................
500 mg
For one film-coated tablet
PHARMACEUTICAL FORM
Film-coated tablets.
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.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment in combination with other anti-epileptic drugs for patients
with resistant partial epilepsy
with or without secondary generalization when all other appropriate
drug combinations have proved
inadequate or have not been tolerated.
POSOLOGY AND METHOD OF ADMINISTRATION
Sabril treatment may only be initiated by a specialist in
epileptology, neurology or pediatric
neurology. Follow-up should be carried out under the supervision of a
specialist in epileptology,
neurology or pediatric neurology.
Sabril is intended for oral administration once or twice daily and can
be taken before or after meals.
The tablets should be swallowed with half a glass of water.
If there is no clinically significant improvement in epileptic
symptoms following well-conducted initial
treatment, vigabatrin must not be continued. Vigabatrin should
gradually be withdrawn under close
medical supervision.
Tablets are not suitable for children under the age of 6 years,
because of the risk of choking.
Adults
Maximum efficacy is usually obtained with a daily dose of 2 to 3 g. A
starting dose of 1 g daily
should be added to the patient’s current anti-epileptic drug
regimen. The daily dose must then be
increased in 0.5 g increments at weekly intervals depending on
clinical response and tolerability.
The maximum recommended dose is 3 g/day.
There is no correlation between the plasma concentrations and
efficacy. The