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

lupin pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - tydemytm is indicated for use by women to prevent pregnancy. tydemy is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. do not prescribe tydemy to women who are known to have the following: - 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

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) - drospirenone 3 mg - lo-zumandiminetm is indicated for use by females of reproductive potential to prevent pregnancy. lo-zumandimine is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of lo-zumandimine for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

bayer (pty) ltd û isando - tablet - see ingredients - each tablet contains drospirenone 2,0 mg oestradiol hemihydrate equivalent to oestradiol 1,0 mg

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

lupin australia pty limited - drospirenone; ethinylestradiol; ethinyloestradiol -

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

lupin australia pty limited - drospirenone; ethinylestradiol; ethinyloestradiol -

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

alphapharm pty ltd - ethinylestradiol, quantity: 0.02 mg; drospirenone, quantity: 3 mg - tablet - excipient ingredients: polacrilin potassium; magnesium stearate; lactose monohydrate - drospirenone/ethinyloestradiol-alphapharm 3/20 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/ethinyloestradiol 20 ?g tablets for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg/ethinyloestradiol 20 ?g tablets has not been evaluated for treatment of pms (premenstrual syndrome) (see clinical trials).

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

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - yaz 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 yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.

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

bayer australia ltd - ethinylestradiol, quantity: 0.03 mg; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: titanium dioxide; purified talc; lactose monohydrate; magnesium stearate; hypromellose; microcrystalline cellulose - indications: petibelle is indicated for use as an oral contraceptive.

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

bayer australia ltd - ethinylestradiol, quantity: 0.03 mg; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose monohydrate; purified talc; titanium dioxide; magnesium stearate; hypromellose; microcrystalline cellulose - indications: yasmin is indicated for use as an oral contraceptive.

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.