Sabril

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VIGABATRIN

Available from:

Sanofi Malta Limited

ATC code:

N03AG04

INN (International Name):

VIGABATRIN

Pharmaceutical form:

COATED TABLET

Composition:

VIGABATRIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2005-09-28

Patient Information leaflet

DÉFILEMENT
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COULEUR(S) PANTONE 
DANS L’ORDRE PRÉVU 
D’IMPRESSION:
coDE ArTIcLE
7062010
DEscrIPTIF TEcHNIQuE DE L’ArTIcLE
(remplace 7057658)
NOTICE PLIÉE  
(L19)
SABRIL 500 MG / COMPRIMÉS / ANGLETERRE
V7_21 JuL 2014
LAIZE
157,5 MM
REFLEX BLUE
Du NoIr
TRAMES: 
LINÉATURE: 150 LPI
INCLINAISON : 
Taille mini du texte : 
8 PT
coDE LAETus : 
599
DIMENsIoNs : 
210 X 157,5 MM
DÉPLIÉE : 42
0 X 157,5 MM
responsable: M
r
 FrANc Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: [phone]  fax.: [phone]
RECTO / VERSO
À PLAT / P. 1
recto
PACKAGE LEAFLET: 
INFORMATION FOR THE USER
SABRIL 500 MG 
FILM-COATED TABLETS
vigabatrin
 Is this leaflet hard to see or read? 
Phone [phone] for help
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 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 a

Summary of Product characteristics

Page 1 of 13

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Sabril 500mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_ _
Each film-coated tablet contains vigabatrin 500 mg. 

For the full list of excipients, see 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. White to off-white, oval, biconvex, tablets with
a break-line on one side 
and “Sabril” 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 anti-epileptic 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 

Sabril 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 

Sabril 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. 

Page 2 of 13

_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 anti-epileptic medicinal
product regimen.  The daily dose should 
then be titrated in 0.5 g increments at weekly intervals
de