SABRIL vigabatrin 0.5g powder oral sachetl

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vigabatrin, Quantity: 500 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Powder, oral

Composition:

Excipient Ingredients: povidone

Administration route:

Oral

Units in package:

60 sachets x 0.5g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of epilepsy which is not satisfactorily controlled by other antiepileptic drugs.

Product summary:

Visual Identification: White to off-white granular powder.; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-07-17

Patient Information leaflet

SABRIL
®
S
A
B
R
I
L
®
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 whil

Summary of Product characteristics

sabril-ccdsv14-piv14-22dec21
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – SABRIL
® (VIGABATRIN)
TABLETS AND ORAL POWDER
1
NAME OF THE MEDICINE
Vigabatrin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg vigabatrin
Each oral powder sachet contains 500 mg vigabatrin
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets: 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
drugs
4.2
DOSE AND METHOD OF ADMINISTRATION
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 daily dose of 2 g (4 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. Increasing the dose beyond 4 g/day does not usually
result in greater efficacy.
Use of vigabatrin should be under the general direction of a
specialist practitioner who is
experienced in the treatment of epilepsy (see Section 4.4 Special
Warnings and Precautions
for Use).
sabril-ccdsv14-piv14-22dec21
Page 2 of 14
THERAPEUTIC DOSE
_ADULTS _
Starting dose is 2 g daily, which should be added on to the patient's
current antiepileptic drug
regimen. If necessary, the dose may be increased or decreased in 1.0 g
increments as
clinically warranted up to 4 g/day.
_CHILDREN _
3-9 years old :
Starting dose 1g daily.
> 10 years old:
Starting dose 2g daily.
When administering the sachet, the contents of the sachet should be
dissolved in water or a
soft drink immediately prior to oral administration.
4