AROPAX CR paroxetine 25mg (as hydrochloride hemihydrate) modified release tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paroxetine hydrochloride hemihydrate, Quantity: 28.51 mg (Equivalent: paroxetine, Qty 25 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

paroxetine hydrochloride hemihydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: lactose monohydrate; hypromellose; povidone; silicon dioxide; magnesium stearate; glyceryl behenate; iron oxide red; methacrylic acid copolymer; purified talc; triethyl citrate; titanium dioxide; polysorbate 80; macrogol 400; vat red 1

Administration route:

Oral

Units in package:

7 tablets - sample pack, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AROPAX CR is indicated for the treatment of major depressive disorder and panic disorder, social anxiety disorder/social phobia and treatment of premenstrual dysphoric disorder. AROPAX CR has not been evaluated beyond 12 weeks, 10 weeks, 12 weeks and 3 menstrual cycles in controlled clinical trails for the treatment of major depression, panic disorder, social anxiety disorder and premenstrual dysphoric disorder, respectively.

Product summary:

Visual Identification: Pink, round, biconvex film-coated tablet with bevelled edges. One side engraved with "GSK", the other with "25".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-05-27