Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - ethinylestradiol; drospirenone - film-coated tablet - 0.03/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - norethindrone acetate and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected * typical † (no contraception)  (85) (85) oral contraceptives    3       combined  0.1 n/a ‡       progestin only  0.5 n/a ‡ diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal        suppositories and vaginal film)  6 26 vaginal sponge           nulliparous  9 20       parous 20 40 implant  0.05 0.05 injection: depot medroxyprogesterone acetate  0.3 0.3 iud           progesterone t  1.5 2.0       copper t 380a  0.6 0.8       lng 20  0.1 0.1 condom without spermicides           female  5 21       male  3 14 cervical cap with spermicidal cream or jelly           nulliparous  9 20       parous  26 40 periodic abstinence (all methods)  1-9 25 withdrawal  4 19 female sterilization  0.5 0.5 male sterilization  0.10 0.15  

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected * typical † (no contraception)  (85) (85) oral contraceptives  3       combined  0.1 n/a ‡       progestin only  0.5 n/a ‡ diaphragm with spermicidal cream or jelly  6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)  6 26 vaginal sponge       nulliparous  9 20       parous 20 40 implant  0.05 0.05 injection: depot medroxyprogesterone acetate  0.3 0.3 iud       progesterone t  1.5 2.0       copper t 380a  0.6 0.8       lng 20  0.1 0.1 condom without spermicides       female  5 21       male  3 14 cervical cap with spermicidal cream or jelly       nulliparous  9 20       parous  26 40 periodic abstinence (all methods)  1-9 25 withdrawal  4 19 female sterilization  0.5 0.5 male sterilization  0.10 0.15  

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 20 ug - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)] . the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early 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 low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during preg

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3) - ethinyl estradiol 0.02 mg - desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year * (4) method (1) typical use † (2) perfect use ‡ (3) chance§ 85 85 spermicides¶ 26 6 40 periodic abstinence 25 63      calendar 9      ovulation method 3      sympto-thermal# 2      post-ovulation 1 withdrawal 19 4 capÞ      parous women 40 26 42      nulliparous women 20 9 56 sponge      parous women 40 20 42      nulliparous women 20

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), ethynodiol diacetate (unii: 62h10a1236) (ethynodiol - unii:9e01c36a9s) - ethinyl estradiol 50 ug - ethynodiol diacetate and ethinyl estradiol tablets usp, 1 mg/50 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptive products such as ethynodiol diacetate and ethinyl estradiol tablets, which contain 50 mcg of estrogen, should not be used unless medically indicated. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year  ‡ method (1) typical use § (2) perfect use ¶ (3) (4) chance # 85 85 spermicides Þ 26 6 40 periodic abstinence 25 63    c

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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.03 mg - drospirenone and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:      •      renal impairment      •      adrenal insufficiency       •      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) ]            

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.03 mg - drospirenone and ethinyl estradiol tablets usp are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets 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 atrial fibrillation) [see warnings and precautions (5.1) ]          

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets 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, levonorgestrel and ethinyl estradiol tablets 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 cocs 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. contraceptive hormones and/or metabolites are present in human milk. cocs can red

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies. thrombogenic rhythm disorders. diabetes with vascular involvement. uncontrolled hypertension. known or suspected carcinoma of the breast. carcinoma of the endometrium or other known or suspecte