Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 30 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; povidone; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - indicated for use as an oral contraceptive

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Ireland - English - HPRA (Health Products Regulatory Authority)

theramex ireland limited - drospirenone; ethinyl estradiol - film-coated tablet - 0.02 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

j m mcgill ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

colorama pharmaceuticals ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

niche pharma ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zumandimine® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. zumandimine is contraindicated in females who are known to have or develop the following conditions: - renal impairment - adrenal insufficiency - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hyper