SABRIL TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS VIGABATRIN 500 mg

Authorization status:

Registered

Authorization date:

1995-02-03

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
Sabril film-coated tablets
500 mg vigabatrin
Date of approval: 16/03/2023
Page 1 of 10
PATIENT INFORMATION LEAFLET
VISUAL FIELD LOSS (LOSS OF SIGHT FROM THE EDGES OF YOUR FIELD OF
VISION) HAS BEEN REPORTED IN
ADULTS AND CHILDREN TAKING SABRIL. YOU SHOULD DISCUSS THIS POSSIBILITY
WITH YOUR DOCTOR
BEFORE YOU BEGIN TREATMENT WITH SABRIL.
MALES ARE AT GREATER RISK THAN FEMALES. MOST OF THE PATIENTS WITH
CONFIRMED VISUAL DEFECTS
DID NOT EXPERIENCE SYMPTOMS. THIS VISUAL FIELD LOSS MAY BE SEVERE, UP
TO TUNNEL VISION OR
LOSS OF VISION, AND IRREVERSIBLE, SO IT MUST BE FOUND EARLY. A
DETERIORATION OF THIS VISUAL FIELD
LOSS AFTER TREATMENT IS DISCONTINUED CANNOT BE EXCLUDED. IT IS
IMPORTANT THAT YOU INFORM YOUR
DOCTOR PROMPTLY IF YOU BECOME AWARE OF ANY CHANGE TO YOUR VISION. YOUR
DOCTOR SHOULD
PERFORM A VISUAL FIELD EXAMINATION AND VISUAL ACUITY TESTING BEFORE
YOU START TAKING SABRIL
AND AT REGULAR INTERVALS DURING THE TREATMENT. YOUR DOCTOR MAY REQUIRE
FROM YOU TO SIGN A
FORM TO ACKNOWLEDGE THAT THIS RISK ASSOCIATED WITH THE USE OF SABRIL
HAS BEEN DISCUSSED
WITH YOU.
SABRIL MAY CAUSE REDUCED VISION DUE TO EYE PROBLEMS SUCH AS RETINAL
DISORDER, BLURRED
VISION, OPTIC ATROPHY OR OPTIC NEURITIS (SEE SECTION 4). IF YOUR
VISION CHANGES CONSULT YOUR
OPHTHALMOLOGIST.
SCHEDULING STATUS:
S3
SABRIL TABLETS FILM-COATED TABLETS
Vigabatrin
Sugar free
sanofi-aventis south africa (pty) ltd
Sabril film-coated tablets
500 mg vigabatrin
Date of approval: 16/03/2023
Page 2 of 10
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SABRIL
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
SABRIL has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What SABRIL is and what it is used for
2.
What you need to know before you use SABRIL
3.
How to use SABRIL
4

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
Sabril film-coated tablets
500 mg vigabatrin
Date of approval: 16/03/2023
Page 1 of 16
PROFESSIONAL INFORMATION FOR SABRIL
VISUAL FIELD DEFECTS HAVE BEEN REPORTED IN PATIENTS RECEIVING SABRIL
WITH A HIGH PREVALENCE
(ABOUT ONE THIRD OF PATIENTS). MALES MAY BE AT GREATER RISK THAN
FEMALES. MOST OF THE PATIENTS
WITH PERIMETRY-CONFIRMED DEFECTS WERE
ASYMPTOMATIC. AVAILABLE EVIDENCE SUGGESTS THAT
VISUAL FIELD DEFECTS (VFD) ARE IRREVERSIBLE EVEN AFTER DISCONTINUATION
OF SABRIL.
DETERIORATION OF VFD AFTER THE TREATMENT IS DISCONTINUED CANNOT BE
EXCLUDED. ALL PATIENTS
SHOULD HAVE OPHTHALMOLOGICAL CONSULTATION WITH VISUAL FIELD
EXAMINATION BEFORE THE
INITIATION OF SABRIL TREATMENT AND AT SIX-MONTH INTERVALS. THE
PRESCRIBER IS ADVISED TO
ENSURE THAT THE PATIENT CONSENT FORM HAS BEEN SIGNED, PRIOR TO ISSUE
OF A PRESCRIPTION FOR
SABRIL.
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
SABRIL TABLETS Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg vigabatrin.
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White to off-white, oval, biconvex tablet with a break line on one
side and SABRIL inscribed on the
other.
sanofi-aventis south africa (pty) ltd
Sabril film-coated tablets
500 mg vigabatrin
Date of approval: 16/03/2023
Page 2 of 16
The break line 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 medicines for
patients with resistant partial
epilepsy with or without secondary generalisation, that is where all
other appropriate medicine
combinations have proved inadequate or have not been tolerated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
SABRIL treatment should only be initiated by a specialist in
neurology, paediatric neurology or
paediatricians who treat patients with epilepsy for which SABRIL is
indicated. Follow-up should be
arranged und