Sabril 500 mg film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Vigabatrin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N03AG; N03AG04

INN (International Name):

Vigabatrin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Fatty acid derivatives; vigabatrin

Authorization status:

Marketed

Authorization date:

1989-12-14

Patient Information leaflet

1
TEXTE
TEXTE
4
1
2
3
VERSO
RECTO
COULEUR(S) PANTONE
DANS L’ORDRE PRÉVU
D’IMPRESSION:
CODE ARTICLE
7099929
DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7099208)
NOTICE DOUBLE
(L19)
SABRIL 500 MG / COMPRIMÉS / IRLANDE
V2_14 JAN 2021
LAIZE
157,5 MM
REFLEX BLUE
DU NOIR
TRAMES:
LINÉATURE: 150 LPI
INCLINAISON :
Taille mini du texte : 9 PT
CODE LAETUS : 735
DIMENSIONS
210 X 157,5 MM
Responsable: M
r
FRANC Pascal
PATHEON France,
une branche de Thermo Fisher Scientific
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: [phone]
fax.: [phone]
RECTO / VERSO
EN ROULEAU / P. 1
1
DÉFILEMENT
Recto
PACKAGE LEAFLET: INFORMATION FOR THE USER
SABRIL
® 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 sings 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 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

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2021
CRN009V28
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sabril 500 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg 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 “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 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
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.
Adults
Maximal efficacy is usually seen in the 2- 3g/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 0.5g increments at weekly intervals
depending on clinical response and tolerability. The highest
recommended dose is 3g/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