Stany Zjednoczone - angielski - NLM (National Library of Medicine)

physicians total care, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - jintelitm (norethindrone acetate and ethinyl estradiol tablets, usp) are indicated in women with an intact uterus for the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. risk factors for osteoporosis include low bone mineral dens

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

amneal pharmaceuticals llc - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only eluryng™ is indicated for use by females of reproductive age to prevent pregnancy. eluryng is contraindicated in females who are known to have or develop the following conditions: - 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 hypertension [see warnings and precautions (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3)  and use in specific populations (8.6) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1) ] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of eluryng [see warnings and precautions (5.6)  and adverse reactions (6)] -   use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] . risk summary eluryng is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue eluryng use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eluryng and any potential adverse effects on the breastfed child from eluryng or from the underlying maternal condition. safety and efficacy of eluryng have 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. eluryng has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of eluryng has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal [see contraindications (4)  and warnings and precautions (5.3) ]. the effect of renal impairment on the pharmacokinetics of eluryng has not been studied. eluryng ™ (el’ue ring) (etonogestrel and ethinyl estradiol vaginal ring) read these instructions for use before you start using eluryng and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your treatment. how should i start using eluryng? if you are not currently using hormonal birth control, you have 2 ways to start using eluryng. choose the best way for you: - first day start: insert eluryng on the first day of your menstrual period. you will not need to use another birth control method since you are using eluryng on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start eluryng on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of eluryng use in the first cycle. if you are changing from a birth control pill or patch to eluryng: if you have been using your birth control method correctly and are certain that you are not pregnant, you can change to eluryng any day. do not start eluryng any later than the day you would start your next birth control pill or apply your patch. if you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (ius): - you may switch from a minipill on any day. start using eluryng on the day that you would have taken your next minipill. - you should switch from an implant or the ius and start using eluryng on the day that you remove the implant or ius. - you should switch from an injectable and start using eluryng on the day when your next injection would be due. if you are changing from a minipill, implant or injection or from an intrauterine system (ius), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using eluryng. if you start using eluryng after an abortion or miscarriage: - following a first trimester abortion or miscarriage: you may start eluryng within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). you do not need to use an additional birth control method . - if you do not start eluryng within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. begin eluryng at the time of your next menstrual period. count the first day of your menstrual period as “day 1” and start eluryng one of the following 2 ways below. - first day start: insert eluryng on the first day of your menstrual period. you will not need to use another birth control method since you are using eluryng on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start eluryng on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of eluryng use in the first cycle. - following a second trimester abortion or miscarriage: you may start using eluryng no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). if you are starting eluryng after childbirth: - you may start using eluryng no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - if you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. you may need a pregnancy test to make sure you are not pregnant before you start using eluryng. - use another birth control method such as male condoms with spermicide for the first 7 days in addition to eluryng. if you are breastfeeding you should not use  eluryng. use other birth control methods until you are no longer breastfeeding. step 1. choose a position for insertion of eluryng. - choose the position that is comfortable for you. for example, lying down, squatting, or standing with 1 leg up (see figures a, b, and c) . positions for eluryng insertion                                                    figure a                                                 figure b                                         figure c step 2. open the pouch to remove your eluryng. - each eluryng comes in a re-sealable foil pouch. - wash and dry your hands before removing eluryng from the foil pouch. - open the foil pouch at either notch near the top. - keep the foil pouch so you can place your used eluryng in it before you throw it away in your household trash. step 3. prepare eluryng for insertion. - hold eluryng between your thumb and index finger and press the sides of the ring together (see figures d and e) .                                                    figure d                                                         figure e step 4. insert eluryng into your vagina. - insert the folded eluryng into your vagina and gently push it further up into your vagina using your index finger (see figures f and g). - when you insert eluryng it may be in different positions in your vagina, but eluryng does not have to be in an exact position for it to work (see figures h and i). - eluryng may move around slightly within your vagina. this is normal. although some women may be aware of eluryng in the vagina, most women do not feel it when it is in place.   figure f                                     figure g                                             figure h                                 figure i inserting eluryng (figure f, figure g) and positioning eluryng (figure h, figure i) note: - if the eluryng feels uncomfortable, you may not have pushed the ring into your vagina far enough. use your finger to gently push the eluryng as far as you can into your vagina. there is no danger of eluryng being pushed too far up in the vagina or getting lost (see figure g) . - some women have accidentally inserted eluryng into their bladder. if you have pain during or after insertion and you cannot find eluryng in your vagina, call your healthcare provider right away. - regularly check that eluryng is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. step 5. how do i remove eluryng? - wash and dry your hands. - choose the position that is most comfortable for you (see figures a, b, and c) . - put your index finger into your vagina and hook it through the eluryng. gently pull downward and forward to remove the eluryng and pull it out (see figure j) .                        figure j step 6. throw away the used eluryng. - place the used eluryng in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - do not throw eluryng in the toilet. what else should i know about using eluryng? what if i leave eluryng in too long? - if you leave eluryng in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. remove your old eluryng for 1 week (7 days) and insert a new eluryng 1 week (7 days) later (see steps 1 through 4) . - if you leave eluryng in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. if you are not pregnant, insert a new eluryng (see steps 1 through 4). you must use another birth control method, such as male condoms with spermicide, until the new eluryng has been used for 7 days in a row. what should i do if my eluryng comes out of my vagina? eluryng can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - eluryng may break causing the ring to lose its shape. if the ring stays in your vagina this should not lower eluryng’s effectiveness at preventing pregnancy. - if eluryng breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - insert a new eluryng (see steps 1 through 4) . - you should pay attention when removing a tampon to be sure that your eluryng is not accidentally pulled out. be sure to insert eluryng before inserting a tampon. if you accidentally pull out your eluryng while using tampons, rinse your eluryng in cool to lukewarm (not hot) water and insert it again right away. - be sure to insert eluryng before inserting a tampon. - if you accidentally pull out your eluryng while using tampons, rinse your eluryng in cool to lukewarm (not hot) water and insert it again right away. - eluryng can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled eluryng in cool to lukewarm (not hot) water and insert it again right away. if the expelled eluryng has been out of your vagina for more than 3 continuous hours: - if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled eluryng in cool to lukewarm (not hot) water and insert it again right away. - if the expelled eluryng has been out of your vagina for more than 3 continuous hours: - during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - during week 3, do not reinsert the eluryng that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new eluryng  has been used for 7 days in a row, following one of the two options below: -           option 1. insert a new ring right away to start your next 21 day eluryng use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. -           option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used eluryng for 7 days in a row, prior to the day that your previous eluryng was accidentally removed or expelled. - if eluryng was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj  08807 rev. 05-2022-03

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

a-s medication solutions - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring is contraindicated in females who are known to have or develop the following conditions: - 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 hypertension [see warnings and precautions (5.5)] have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - 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 hypertension [see warnings and precautions (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of etonogestrel/ethinyl estradiol vaginal ring [see warnings and precautions (5.6) and adverse reactions (6)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] risk summary etonogestrel/ethinyl estradiol vaginal ring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue etonogestrel/ethinyl estradiol vaginal ring use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for etonogestrel/ethinyl estradiol vaginal ring and any potential adverse effects on the breastfed child from etonogestrel/ethinyl estradiol vaginal ring or from the underlying maternal condition. safety and efficacy of etonogestrel/ethinyl estradiol vaginal ring have 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. etonogestrel/ethinyl estradiol vaginal ring has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal. [see contraindications (4) and warnings and precautions (5.3).] the effect of renal impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. instructions for use etonogestrel/ethinyl estradiol vaginal ring read these instructions for use before you start using etonogestrel/ethinyl estradiol vaginal ring and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your treatment. how should i start using etonogestrel/ethinyl estradiol vaginal ring? if you are not currently using hormonal birth control, you have 2 ways to start using etonogestrel/ethinyl estradiol vaginal ring. choose the best way for you: - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. if you are changing from a birth control pill or patch to etonogestrel/ethinyl estradiol vaginal ring: if you have been using your birth control method correctly and are certain that you are not pregnant, you can change to etonogestrel/ethinyl estradiol vaginal ring any day. do not start etonogestrel/ethinyl estradiol vaginal ring any later than the day you would start your next birth control pill or apply your patch. if you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (ius): - you may switch from a minipill on any day. start using etonogestrel/ethinyl estradiol vaginal ring on the day that you would have taken your next minipill. - you should switch from an implant or the ius and start using etonogestrel/ethinyl estradiol vaginal ring on the day that you remove the implant or ius. - you should switch from an injectable and start using etonogestrel/ethinyl estradiol vaginal ring on the day when your next injection would be due. if you are changing from a minipill, implant or injection or from an intrauterine system (ius), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using etonogestrel/ethinyl estradiol vaginal ring. if you start using etonogestrel/ethinyl estradiol vaginal ring after an abortion or miscarriage: - following a first trimester abortion or miscarriage: you may start etonogestrel/ethinyl estradiol vaginal ring within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). you do not need to use an additional birth control method. - if you do not start etonogestrel/ethinyl estradiol vaginal ring within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. begin etonogestrel/ethinyl estradiol vaginal ring at the time of your next menstrual period. count the first day of your menstrual period as "day 1" and start etonogestrel/ethinyl estradiol vaginal ring one of the following 2 ways below. first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - following a second trimester abortion or miscarriage: you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). if you are starting etonogestrel/ethinyl estradiol vaginal ring after childbirth: - you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - if you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. you may need a pregnancy test to make sure you are not pregnant before you start using etonogestrel/ethinyl estradiol vaginal ring. - use another birth control method such as male condoms with spermicide for the first 7 days in addition to etonogestrel/ethinyl estradiol vaginal ring. if you are breastfeeding you should not use etonogestrel/ethinyl estradiol vaginal ring. use other birth control methods until you are no longer breastfeeding. step 1. choose a position for insertion of etonogestrel/ethinyl estradiol vaginal ring. - choose the position that is comfortable for you. for example, lying down, squatting, or standing with 1 leg up (see figures a, b, and c) . positions for etonogestrel/ethinyl estradiol vaginal ring insertion step 2. open the pouch to remove your etonogestrel/ethinyl estradiol vaginal ring. - each etonogestrel/ethinyl estradiol vaginal ring comes in a re-sealable foil pouch. - wash and dry your hands before removing etonogestrel/ethinyl estradiol vaginal ring from the foil pouch. - open the foil pouch at either notch near the top. - keep the foil pouch so you can place your used etonogestrel/ethinyl estradiol vaginal ring in it before you throw it away in your household trash. step 3. prepare etonogestrel/ethinyl estradiol vaginal ring for insertion. - hold etonogestrel/ethinyl estradiol vaginal ring between your thumb and index finger and press the sides of the ring together (see figures d and e) . step 4. insert etonogestrel/ethinyl estradiol vaginal ring into your vagina. - insert the folded etonogestrel/ethinyl estradiol vaginal ring into your vagina and gently push it further up into your vagina using your index finger (see figures f and g) . - when you insert etonogestrel/ethinyl estradiol vaginal ring it may be in different positions in your vagina, but etonogestrel/ethinyl estradiol vaginal ring does not have to be in an exact position for it to work (see figures h and i) . - etonogestrel/ethinyl estradiol vaginal ring may move around slightly within your vagina. this is normal. although some women may be aware of etonogestrel/ethinyl estradiol vaginal ring in the vagina, most women do not feel it when it is in place. inserting etonogestrel/ethinyl estradiol vaginal ring (figure f, figure g) and positioning etonogestrel/ethinyl estradiol vaginal ring (figure h, figure i) note: - if the etonogestrel/ethinyl estradiol vaginal ring feels uncomfortable, you may not have pushed the ring into your vagina far enough. use your finger to gently push the etonogestrel/ethinyl estradiol vaginal ring as far as you can into your vagina. there is no danger of etonogestrel/ethinyl estradiol vaginal ring being pushed too far up in the vagina or getting lost (see figure g). - some women have accidentally inserted etonogestrel/ethinyl estradiol vaginal ring into their bladder. if you have pain during or after insertion and you cannot find etonogestrel/ethinyl estradiol vaginal ring in your vagina, call your healthcare provider right away. - regularly check that etonogestrel/ethinyl estradiol vaginal ring is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. step 5. how do i remove etonogestrel/ethinyl estradiol vaginal ring? - wash and dry your hands. - choose the position that is most comfortable for you (see figures a, b, and c). - put your index finger into your vagina and hook it through the etonogestrel/ethinyl estradiol vaginal ring. gently pull downward and forward to remove the etonogestrel/ethinyl estradiol vaginal ring and pull it out (see figure j).                                     figure j step 6. throw away the used etonogestrel/ethinyl estradiol vaginal ring. - place the used etonogestrel/ethinyl estradiol vaginal ring in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - do not throw etonogestrel/ethinyl estradiol vaginal ring in the toilet. what else should i know about using etonogestrel/ethinyl estradiol vaginal ring? what if i leave etonogestrel/ethinyl estradiol vaginal ring in too long? - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. remove your old etonogestrel/ethinyl estradiol vaginal ring for 1 week (7 days) and insert a new etonogestrel/ethinyl estradiol vaginal ring 1 week (7 days) later (see steps 1 through 4) . - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. if you are not pregnant, insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4) . you must use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row. what should i do if my etonogestrel/ethinyl estradiol vaginal ring comes out of my vagina? etonogestrel/ethinyl estradiol vaginal ring can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - etonogestrel/ethinyl estradiol vaginal ring may break causing the ring to lose its shape. if the ring stays in your vagina this should not lower etonogestrel/ethinyl estradiol vaginal ring's effectiveness at preventing pregnancy. if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - you should pay attention when removing a tampon to be sure that your etonogestrel/ethinyl estradiol vaginal ring is not accidentally pulled out. be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. - if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - etonogestrel/ethinyl estradiol vaginal ring can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if etonogestrel/ethinyl estradiol vaginal ring was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. zenchent fe is contraindicated in females who are known to have or develop the following conditions: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see warnings and precautions (5.4)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.6)] - have headaches with focal neurological symptoms or have migraine headaches with aura [see warnings and precautions (5.7)] - women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9)  and use in specific populations (8.1)] . - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - hypersensitivity to any of the components. - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.3)] 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. do not use cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of zenchent fe have been established in women of reproductive age. efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. zenchent fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of zenchent fe has not been studied in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [see contraindications (4)  and warnings and precautions (5.2)] . the pharmacokinetics of zenchent fe has not been studied in women with renal impairment. zenchent fe norethindrone and ethinyl estradiol tablets and ferrous fumarate tablets   important information about taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - both the light yellow pills and the brown pills may be swallowed whole or chewed and swallowed. if the pill is chewed, drink a full glass (8 ounces) of liquid immediately after swallowing. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets, talk to your healthcare provider. when you first start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister pack. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets? if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. you do not need back-up contraception if you use the day 1 start. if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from another birth control pill: - start your new zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch: - start using zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day you would have reapplied the next ring or patch.  if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection: - start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day of removal of your implant or on the day when you would have had your next injection. if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from an intrauterine device or system (iud or ius): - start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, “when should i start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets? ” above. follow these instructions for either a sunday start or a day 1 start. sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts . - if your period starts on a sunday, take pill “1 ” that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period. - take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. instructions for using your pill pack: step 1. look at your zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pill pack. see figure a. the zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pill pack has: - 21 light yellow (active) pills with hormone for week 1 through week 3. - 7 brown (inactive) pills without hormones for week 4. figure a step 2. find: - where on your pack to start taking pills - in what order to take your pills (follow the arrows) - the week numbers step 3. remove the light yellow pill by pressing the pill through the foil in the bottom of the pill pack. see figure b. continue taking the light yellow pills for 21 days. figure b step 4. on the first day of week 4 start taking the brown pills. take the brown pill for 7 days. your period should start during this time. step 5. when you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the light yellow pills. - for a day 1 start: begin your next pill pack on the same day of the week as your first cycle pill pack. begin your next pill pack on the same day of the week as your first cycle pill pack. - for a sunday start: begin your next pill pack on sunday. begin your next pill pack on sunday. what should i do if i miss any zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps: - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: throw out the rest of the pill pack and start a new pack that same day. - throw out the rest of the pill pack and start a new pack that same day. - if you are a sunday starter: keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 revised: 05-2022-03

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

mayne pharma inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only haloette® is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe haloette to women who are known to have or use the following: - 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 hypertension [see warnings and precautions (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of haloette [see warnings and precautions (5.6) and adverse reactions (6)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] risk summary haloette is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue haloette use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, preimplantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for haloette and any potential adverse effects on the breastfed child from haloette or from the underlying maternal condition. safety and efficacy of haloette have 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. haloette has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of haloette has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal. [see contraindications (4) and warnings and precautions (5.3).] the effect of renal impairment on the pharmacokinetics of haloette has not been studied. haloette® (ha loe et) (etonogestrel and ethinyl estradiol vaginal ring) read these instructions for use before you start using haloette and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your treatment. how should i start using haloette? if you are not currently using hormonal birth control, you have 2 ways to start using haloette. choose the best way for you: - first day start: insert haloette on the first day of your menstrual period. you will not need to use another birth control method since you are using haloette on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start haloette on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of haloette use in the first cycle. if you are changing from a birth control pill or patch to haloette: if you have been using your birth control method correctly and are certain that you are not pregnant, you can change to haloette any day. do not start haloette any later than the day you would start your next birth control pill or apply your patch. if you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (ius): - you may switch from a minipill on any day. start using haloette on the day that you would have taken your next minipill. - you should switch from an implant or the ius and start using haloette on the day that you remove the implant or ius. - you should switch from an injectable and start using haloette on the day when your next injection would be due. if you are changing from a minipill, implant or injection or from an intrauterine system (ius), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using haloette. if you start using haloette after an abortion or miscarriage: - following a first trimester abortion or miscarriage: you may start haloette within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). you do not need to use an additional birth control method . - if you do not start haloette within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. begin haloette at the time of your next menstrual period. count the first day of your menstrual period as "day 1" and start haloette one of the following 2 ways below. first day start: insert haloette on the first day of your menstrual period. you will not need to use another birth control method since you are using haloette on the first day of your menstrual period. day 2 to day 5 cycle start: you may choose to start haloette on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of haloette use in the first cycle. - first day start: insert haloette on the first day of your menstrual period. you will not need to use another birth control method since you are using haloette on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start haloette on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of haloette use in the first cycle. - following a second trimester abortion or miscarriage: you may start using haloette no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). if you are starting haloette after childbirth: - you may start using haloette no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - if you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. you may need a pregnancy test to make sure you are not pregnant before you start using haloette. - use another birth control method such as male condoms with spermicide for the first 7 days in addition to haloette. if you are breastfeeding you should not use haloette. use other birth control methods until you are no longer breastfeeding. step 1. choose a position for insertion of haloette. - choose the position that is comfortable for you. for example, lying down, squatting, or standing with 1 leg up (see figures a, b, and c) . positions for haloette insertion step 2. open the pouch to remove your haloette. - each haloette comes in a re-sealable foil pouch. - wash and dry your hands before removing haloette from the foil pouch. - open the foil pouch at either notch near the top. - keep the foil pouch so you can place your used haloette in it before you throw it away in your household trash. step 3. prepare haloette for insertion. - hold haloette between your thumb and index finger and press the sides of the ring together (see figures d and e) . step 4. insert haloette into your vagina. - insert the folded haloette into your vagina and gently push it further up into your vagina using your index finger (see figures f and g) . - when you insert haloette it may be in different positions in your vagina, but haloette does not have to be in an exact position for it to work (see figures h and i) . - haloette may move around slightly within your vagina. this is normal. although some women may be aware of haloette in the vagina, most women do not feel it when it is in place. inserting haloette (figure f, figure g) and positioning haloette (figure h, figure i) note: - if the haloette feels uncomfortable, you may not have pushed the ring into your vagina far enough. use your finger to gently push the haloette as far as you can into your vagina. there is no danger of haloette being pushed too far up in the vagina or getting lost (see figure g). - some women have accidentally inserted haloette into their bladder. if you have pain during or after insertion and you cannot find haloette in your vagina, call your healthcare provider right away. - regularly check that haloette is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. step 5. how do i remove haloette? - wash and dry your hands. - choose the position that is most comfortable for you (see figures a, b, and c). - put your index finger into your vagina and hook it through the haloette. gently pull downward and forward to remove the haloette and pull it out (see figure j) . step 6. throw away the used haloette. - place the used haloette in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - do not throw haloette in the toilet. what else should i know about using haloette? what if i leave haloette in too long? - if you leave haloette in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. remove your old haloette for 1 week (7 days) and insert a new haloette 1 week (7 days) later (see steps 1 through 4) . - if you leave haloette in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. if you are not pregnant, insert a new haloette (see steps 1 through 4) . you must use another birth control method, such as male condoms with spermicide, until the new haloette has been used for 7 days in a row. what should i do if my haloette comes out of my vagina? haloette can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - haloette may break causing the ring to lose its shape. if the ring stays in your vagina this should not lower haloette's effectiveness at preventing pregnancy. if haloette breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. insert a new haloette (see steps 1 through 4). - if haloette breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - insert a new haloette (see steps 1 through 4). - you should pay attention when removing a tampon to be sure that your haloette is not accidentally pulled out. be sure to insert haloette before inserting a tampon. if you accidentally pull out your haloette while using tampons, rinse your haloette in cool to lukewarm (not hot) water and insert it again right away. - be sure to insert haloette before inserting a tampon. - if you accidentally pull out your haloette while using tampons, rinse your haloette in cool to lukewarm (not hot) water and insert it again right away. - haloette can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled haloette in cool to lukewarm (not hot) water and insert it again right away. if the expelled haloette has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the haloette that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new haloette has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day haloette use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used haloette for 7 days in a row, prior to the day that your previous haloette was accidentally removed or expelled. - if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled haloette in cool to lukewarm (not hot) water and insert it again right away. - if the expelled haloette has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the haloette that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new haloette has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day haloette use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used haloette for 7 days in a row, prior to the day that your previous haloette was accidentally removed or expelled. - during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - during week 3, do not reinsert the haloette that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new haloette has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day haloette use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. - if haloette was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration. distributed by: mayne pharma greenville, nc 27834 revised: 05/2022

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

naari pte limited - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg is contraindicated in females who are known to have or develop the following conditions: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see warnings and precautions (5.4) ] ▪ have diabetes mellitus with vascular disease [see warnings and precautions (5.6) ] ▪ have headaches with focal neurological symptoms or have migraine headaches with aura [see warnings and precautions (5.7) ]       ▪ women over age 35 with any migraine headaches [see warnings and precautions (5.7) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9) ] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1) ]. - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - hypersensitivity to any of the components. - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.3)] 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. do not use cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have been established in women of reproductive age. efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [see contraindications (4) and warnings and precautions (5.2)]. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women with renal impairment. instructions for use important information about taking - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - the norethindrone and ethinyl estradiol tablets, usp may be swallowed whole or chewed. if norethindrone and ethinyl estradiol tablets, usp are chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, talk to your healthcare provider. when you first start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister pack. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets ? if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. you do not need back-up contraception if you use the day 1 start. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from another birth control pill: - start your new norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletspack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch: - start using norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day you would have reapplied the next ring or patch. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection: - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your implant or on the day when you would have had your next injection. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from an intrauterine device or system (iud or ius): - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, “ when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets? ” above.follow these instructions for either a sunday start or a day 1 start. sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts. - if your period starts on a sunday, take pill “ 1 ” that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period . - take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. instructions for using your pill pack: step 1 . look at your norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack. see figure a. the norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack has: - 21 white to off white (active) pills with hormone for week 1 through week 3. - 7 brown (inactive) pills without hormones for week 4. step 2. find: - where on your pack to start taking pills - in what order to take your pills (follow the arrows) - the week numbers step 3. remove the white to off white pill by pressing the pill through the foil in the bottom of the pill pack. see figure b . continue taking the white to off white pills for 21 days. figure b step 4. on the first day of week 4 start taking the brown pills. take the brown pill for 7 days . your period should start during this time. step 5. when you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the white to off white pills. - for a day 1 start: begin your next pill pack on the same day of the week as your first cycle pill pack. - for a sunday start: begin your next pill pack on sunday. what should i do if i miss any norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps : - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: • throw out the rest of the pill pack and start a new pack that same day. - if you are a sunday starter: • keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use has been approved by the u.s. food and drug administration. manufactured for: naari pte limited 36 robinson road, #13-01 city house, singapore 068877 issued december 2021

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

merck sharp & dohme australia pty ltd - etonogestrel; ethinylestradiol -

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

alphapharm pty ltd - rifampicin -

Australia - angielski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - oestradiol benzoate; progesterone - parenteral implant, device - oestradiol benzoate steroid-estrogen active 20.0 mg/im; progesterone steroid-progestin active 200.0 mg/im - nutrition & metabolism - steer (castrated male cattle) | beef | bovine | bullock (young) | male cattle - castrated - promote animal growth | feed conversion | finishing | growth promotion | growth rate | liveweight gain

Australia - angielski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - tylosin tartrate; oestradiol benzoate; progesterone - parenteral implant, device - tylosin tartrate antibiotic active 29.0 mg; oestradiol benzoate steroid-estrogen active 20.0 mg; progesterone steroid-progestin active 200.0 mg - nutrition & metabolism - steer (castrated male cattle) | beef | bovine | bullock (young) | male cattle - castrated - promote animal growth | feed conversion | finishing | growth promotion | growth rate | liveweight gain