APOTEX-DROSPIRENONE/EE 3/20 drospirenone 3 mg and ethinylestradiol 20 microgram film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; povidone; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

3 x 28s (24 Active Tablets + 4 Placebo Tablets), 1 x 28s (24 Active Tablets + 4 Placebo Tablets)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for PMDD was not assessed beyond 3 cycles. Drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of PMS (premenstrual syndrome), see section 5.1 Pharmacodynamic Properties - Clinical trials.

Product summary:

Visual Identification: Plain, round, white, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-07-15