APO-TOPIRAMATE topiramate 25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

topiramate, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Topiramate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; hyprolose; methylcellulose; hypromellose; macrogol 8000; titanium dioxide; magnesium stearate

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Epilepsy. Adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome. Migraine. Prophylaxis of migraine headache in adults.

Product summary:

Visual Identification: White to off-white, round, unscored, film coated tablet, imprinted "APO" on one side and "TP" over "25" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-07-20

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-TOPIRAMATE (TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate, as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-TOPIRAMATE TABLETS:
25 MG TABLETS:
White to off-white, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP
over “25” on the other side.
50 MG TABLETS:
Light-yellow, round, unscored, film coated tablet, imprinted “APO”
on one side and “TP over
“50” on the other side.
100 MG TABLETS:
Mustard yellow, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP over
“100” on the other side.
200 MG TABLETS:
Reddish-brown, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP over
“200” on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
Adults and children 2 years and over:
•
as monotherapy in patients with newly diagnosed epilepsy
•
for conversion to monotherapy in patients with epilepsy
•
as add-on therapy in partial onset seizures (with or without secondary
generalised
seizures), primary generalised tonic-clonic seizures or drop attacks
associated with
Lennox-Gastaut syndrome.
MIGRAINE
Prophylaxis of migraine headache in adults. The usefulness of
topiramate in the acute
treatment of migraine headache has not been studied.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Topiramate tablets are intended for oral administration
DOSAGE
Topiramate tablets should be swallowed whole.
Topiramate can be taken without regard to meals.
For optimum seizure control in both adults and children, it is
recommended that therapy should
be initiated at a low dose followed by slow titration to an effective
dose. Dose titration should
be guided by clinical outcome.
The recommended dosages of topiramate in adults and children for
epilepsy are summarised
in Table 1.
MONOTHERAPY – EPILEPSY
In n