APO-TOPIRAMATE topiramate 100 mg tablet bottle

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

topiramate, Quantity: 100 mg

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

INN (Internationale Bezeichnung):

Topiramate

Darreichungsform:

Tablet, film coated

Zusammensetzung:

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

Verabreichungsweg:

Oral

Einheiten im Paket:

60 tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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.

Produktbesonderheiten:

Visual Identification: Mustard yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP" over "100" 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

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2007-07-20

Fachinformation

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