Ethinyloestradiol / Drospirenone 20 microgram/3 mg Lupin ethinylestradiol/drospirenone 20 microgram/3 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; magnesium stearate; maize starch; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

2 x 28 tablets, 6 x 28 tablets, 3 x 28 tablets, 4 x 28 tablets, 1 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ethinylestradiol/ Drospirenone tablet is indicated for use as:,?an oral contraceptive.,?treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of Ethinylestradiol/ Drospirenone tablet for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/ Drospirenone tablet has not been evaluated for treatment of PMS (premenstrual syndrome).

Product summary:

Visual Identification: White to off-white round, biconvex film coated tablets, plain on both the sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-09-11