RBX TOPIRAMATE topiramate 100 mg tablets blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

topiramate, Quantity: 100 mg

Beszerezhető a:

Sun Pharma ANZ Pty Ltd

INN (nemzetközi neve):

Topiramate

Gyógyszerészeti forma:

Tablet

Összetétel:

Excipient Ingredients: lactose monohydrate; magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type A; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400

Az alkalmazás módja:

Oral

db csomag:

60

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

1. EPILEPSY. RBX TOPIRAMATE tablets are indicated in 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.. 2. MIGRAINE. RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine headache in adults.

Termék összefoglaló:

Visual Identification: Yellow-coloured, film-coated, circular tablets debossed with 'TP3' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2010-05-10

Termékjellemzők

RBX TOPIRAMATE PI V6
Page 1 of 33
AUSTRALIAN PRODUCT INFORMATION – RBX TOPIRAMATE
(TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of RBX TOPIRAMATE contains 25 mg, 50 mg, 100
mg or 200 mg of
topiramate.
Excipient with known effect: Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
RBX TOPIRAMATE 25 mg tablets are available as white, film-coated,
circular tablets debossed
with ‘TP1’ on one side and plain on the other side.
RBX TOPIRAMATE 50 mg tablets are available as yellow-coloured,
film-coated, circular tablets
debossed with ‘TP2’ on one side and plain on the other side.
RBX TOPIRAMATE 100 mg tablets are available as yellow-coloured,
film-coated, circular tablets
debossed with ‘TP3’ on one side and plain on the other side.
RBX TOPIRAMATE 200 mg tablets are available as peach-coloured,
film-coated, circular tablets
debossed with ‘TP4’ on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_EPILEPSY _
RBX TOPIRAMATE tablets are indicated in 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 _
RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine
headache in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RBX TOPIRAMATE tablets should be swallowed whole.
RBX TOPIRAMATE PI V6
Page 2 of 33
RBX TOPIRAMATE tablets 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 c