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

sigma pharmaceuticals plc - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

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

mawdsley-brooks & company ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

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

theramex hq uk ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

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

morningside healthcare ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

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

a-s medication solutions - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone and ethinyl estradiol tablets in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. risk summary drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone and ethinyl estradiol tablets on the breast-fed infant. chcs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [see also dosage and administration (2.2)]. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. data human data an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months postpartum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. safety and efficacy of drospirenone and ethinyl estradiol tablets has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50 to 79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30 to 49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see clinical pharmacology (12.3)] . drospirenone and ethinyl estradiol tablets are contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)] . the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone and ethinyl estradiol tablets have not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)] .

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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets 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 associat

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

cst 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

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

lupin australia pty limited - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400 - 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).

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

lupin australia pty limited - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; magnesium stearate; maize starch; titanium dioxide; hypromellose; macrogol 400 - 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).