Sabril

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vigabatrin 500mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Vigabatrin 500 mg

Dosage:

500 mg

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Vigabatrin 500mg   Excipient: Povidone

Units in package:

Sachet, 60 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

sanofi-aventis SpA

Therapeutic indications:

For the treatment of epilepsy which is not satisfactorily controlled by other antiepileptic medicines. For the management of infantile spasms (West Syndrome). Monotherapy for the treatment of partial seizure.

Product summary:

Package - Contents - Shelf Life: Sachet, - 60 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1997-05-15

Patient Information leaflet

SABRIL®
1
SABRIL
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SABRIL?
Sabril contains the active ingredient vigabatrin. Sabril is used in
addition to other medicines to treat epilepsy.
For more information, see Section 1. Why am I using Sabril? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE SABRIL?
Do not take if you have ever had an allergic reaction to Sabril or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Sabril? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sabril and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE SABRIL?
•
Sabril tablets and sachets are taken by mouth either once or twice a
day.
•
Take Sabril at about the same time each day.
More instructions can be found in Section 4. How do I take Sabril? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SABRIL?
THINGS YOU
SHOULD DO
•
Tell all the doctors, dentists and pharmacists that are treating you
that you are taking Sabril.
•
Tell your Doctor immediately or go to the Accident and Emergency
department of your nearest
hospital if you have any thoughts of harming yourself or committing
suicide.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Sabril affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets or sachets in the container until it is time to take
them.
•
Keep Sabril in a cool dry place where the temperature stays below
30°C.
For more information, see Section 5. What should I know while us

Summary of Product characteristics

sabril-ccdsv14-dsv15-21sep23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Sabril 500 mg tablets
Sabril 500 mg oral powder
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg vigabatrin
Each oral powder contains 500 mg vigabatrin
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sabril tablets 500 mg (white to off-white, oval biconvex film-coated
tablets with a break-mark on
one side and "SABRIL" or "SABRILEX" engraved on the other side).
Oral powder: White to off-white granular powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of epilepsy which is not satisfactorily controlled
by other antiepileptic
medicines.
For the management of infantile spasms (West Syndrome).
Monotherapy for the treatment of partial seizures and secondarily
generalised tonic-clonic
seizures.
sabril-ccdsv14-dsv15-21sep23
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults
Vigabatrin is intended for oral administration once or twice daily.
Initiation of treatment should
be as add-on therapy in epilepsy which is not satisfactorily
controlled by other drugs. Thus, the
starting dose of 1 g (2 tablets) should be added on to the patient's
current antiepileptic drug
regimen.
If necessary, the daily dose may be increased or decreased in 0.5 g or
1.0 g increments at weekly
or greater intervals depending on clinical response and tolerability.
Maximum efficacy usually
occurs in the range of 2 to 4 g daily; slight increases in efficacy
have been seen at higher doses up
to 6g daily but are associated with increased incidence of adverse
events.
Vigabatrin may be taken before or after meals. The tablets should be
swallowed with a little
water. When administering the oral powder, the contents of the sachet
should be dissolved in half
a glass of water, juice or soft drink immediately prior to oral
administration.
Children
The recommended starting dose is 40 mg/kg/day, increasing to 80 to 100
mg/kg per day,
depending on response.
For maintenance dosing, the recommendations are:
Bodyweight:
10