Sabril 500mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VIGABATRIN

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

N03AG04

INN (International Name):

VIGABATRIN 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VIGABATRIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2005-09-28

Patient Information leaflet

Page 1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SABRILEX 500
MG FILM-COATED 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.
WHAT IS IN THIS LEAFLET
1.
What Sabrilex is and what it is used for
2.
What you need to know before you take Sabrilex
3.
How to take Sabrilex
4.
Possible side effects
5.
How to store Sabrilex
6.
Contents of the pack and other information
1.
WHAT SABRILEX IS AND WHAT IT IS USED FOR
Sabrilex 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 SABRILEX
DO NOT TAKE SABRILEX
-
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 Sabrilex 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
Sabrilex. You should discuss this possibility with your doctor before
you begin treatment with this
medicine. This visual field loss may be severe, up to tunnel vision or
loss of vision, and irreversible, so
it must be fo

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sabrilex 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 500 mg vigabatrin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval, biconvex, tablets with a break-line on one
side and “Sabrilex” engraved on
the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment in combination with other antiepileptic medicinal products
for patients with resistant partial
epilepsy with or without secondary generalisation, that is where all
other appropriate medicinal
product combinations have proved inadequate or have not been
tolerated.
Monotherapy in the treatment of infantile spasms (West’s syndrome).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sabrilex treatment may only be initiated by a specialist in
epileptology, neurology or paediatric
neurology. Follow-up should be arranged under supervision of a
specialist in epileptology, neurology
or paediatric neurology.
Posology
Sabrilex is for oral administration once or twice daily and may be
taken before or after meals.
If the control of epilepsy is not clinically significantly improved
after an adequate trial, vigabatrin
treatment should not be continued. Vigabatrin should be gradually
withdrawn under close medical
supervision.
Adults
Maximal efficacy is usually seen in the 2-3 g/day range. A starting
dose of 1 g daily should be added
to the patient’s current antiepileptic medicinal product regimen.
The daily dose should then be titrated
in 0.5 g increments at weekly intervals depending on clinical response
and tolerability. The highest
recommended dose is 3 g/day.
No direct correlation exists between the plasma concentration and the
efficacy. The duration of the
effect of the medicinal product is dependent on the rate of GABA
transaminase resynthesis rather than
t