GABITRIL tiagabine (as hydrochloride monohydrate) 15mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tiagabine hydrochloride monohydrate, Quantity: 17.2 mg (Equivalent: tiagabine, Qty 15 mg)

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

tiagabine hydrochloride monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: ascorbic acid; stearic acid; crospovidone; magnesium stearate; colloidal anhydrous silica; hydrogenated vegetable oil; lactose; pregelatinised maize starch; microcrystalline cellulose; hypromellose; hyprolose; titanium dioxide

Administration route:

Oral

Units in package:

50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of partial seizures, as add on therapy in patients who are not controlled satisfactorily with other antiepileptic drug(s).

Product summary:

Visual Identification: White, oval tablets, embossing 253; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2006-09-14

Patient Information leaflet

GABITRIL
® TABLETS
_Tiagabine hydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GABITRIL. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GABITRIL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GABITRIL IS
USED FOR
This medicine is used with other
medicines to control some types of
seizures (fits) in people with
epilepsy. Epilepsy is a condition
where you have repeated seizures.
There are many different types of
seizures, ranging from mild to
severe.
This medicine belongs to a group of
medicines called antiepileptics or
anticonvulsants.
It works by increasing the level of a
chemical in the brain (gamma-
aminobutyric acid, or GABA). This
controls the signals in nerve cells so
that seizures do not happen.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor’s
prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 12
years.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE GABITRIL IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
tiagabine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE:
•
if you have severe liver disease
•
in combination with St John Wort
(hypericum perforatum).
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED

Summary of Product characteristics

Teva Pharma Australia Pty Limited Version 1.0 Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – GABITRIL

(TIAGABINE HYDROCHLORIDE MONOHYDRATE)
TABLETS
1
NAME OF THE MEDICINE
Tiagabine hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tiagabine hydrochloride monohydrate has an asymmetric centre. GABITRIL
contains only the R(-)-
enantiomer named (R)-N-(4,4)-di(3-methylthien-2-yl)-but-3-enyl)
nipecotic acid, hydrochloride
monohydrate. It is a white to off-white crystalline powder and is
sparingly soluble in water (22 mg/mL),
soluble in ethanol and practically insoluble in non-polar solvents
such as diethyl ether. For the carboxylic
acid moiety pKa = 3.3; for the amine pKa = 9.4.
GABITRIL is an antiepileptic drug. The active ingredient is tiagabine,
present as tiagabine hydrochloride
monohydrate. Contains lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
GABITRIL 5 mg tablets are white, round, biconvex film-coated tablets
(marked 251). Each 5 mg tablet
contains tiagabine 5 mg in the form of tiagabine hydrochloride
monohydrate
GABITRIL 10 mg tablets are white, oval, biconvex film-coated tablets
(marked 252). Each 10 mg tablet
contains tiagabine 10 mg in the form of tiagabine hydrochloride
monohydrate.
GABITRIL 15 mg tablets are white, oval, biconvex film-coated tablets
(marked 253). Each 15 mg tablet
contains tiagabine 15 mg in the form of tiagabine hydrochloride
monohydrate.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of partial seizures, as add on therapy in patients
who are not controlled satisfactorily
with other antiepileptic drug(s).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults and children over 12 years
GABITRIL should be taken with meals in three daily doses. For optimal
results the dose of GABITRIL
should be titrated for each patient as follows. The initial dosage is
7.5-15 mg daily, followed by weekly
increments of 5-15 mg daily. The usual maintenance dose is in the
range of 30-50 mg daily within which
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