if they do not stop use for any other reason. (c) among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (d) the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. (e) foams, creams, gels, vaginal suppositories, and vaginal film. (f) cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. (g) with spermicidal cream or jelly. (h) without spermicides. (i) the treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. the food and drug administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: ovral (1 dose is 2 white pills), alesse (1 dose is 5 pink pills), nordette or levlen (1 dose is 2 light-orange pills), lo/ovral (1 dose is 4 white pills), triphasil or tri-levlen (1 dose is 4 yellow pills). (j) however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. 14

types: retrospective casecontrol studies and prospective cohort studies. case-control studies provide an estimate of the relative risk of a disease, which is defined as the ratio of the incidence of a disease among oral contraceptive users to that among nonusers. the relative risk (or odds ratio) does not provide information about the actual clinical occurrence of a disease. cohort studies provide a measure of both the relative risk and the attributable risk. the latter is the difference in the incidence of disease between oral contraceptive users and nonusers. the attributable risk does provide information about the actual occurrence or incidence of a disease in the subject population. for further information, the reader is referred to a text on epidemiological methods. 1. thromboembolic disorders and other vascular problems. a. myocardial infarction. an increased risk of myocardial infarction has been associated with oral contraceptive use. 2-21 this increased risk is primarily in smokers or in women with other underlying risk factors for coronary artery disease such as hypertension, obesity, diabetes, and hypercholesterolemia. the relative risk for myocardial infarction in current oral contraceptive users has been estimated to be 2 to 6. the risk is very low under the age of 30. however, there is the possibility of a risk of cardiovascular disease even in very young women who take oral contraceptives. smoking in combination with oral contraceptive use has been reported to contribute substantially to the risk of myocardial infarction in women in their mid-thirties or older, with smoking accounting for the majority of excess cases. 22 mortality rates associated with circulatory disease have been shown to increase substantially in smokers, especially in those 35 years of age and older among women who use oral contraceptives (see figure 1, table 2). figure 1 . circulatory disease mortality rates per 100,000 woman-years by age, smoking status, and oral contraceptive use. 14 adapted from layde and beral. 14 oral contraceptives may compound the effects of well-known cardiovascular risk factors such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age, cigarette smoking, and obesity. in particular, some progestogens decrease hdl cholesterol 23-31 and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. 32 oral contraceptives have been shown to increase blood pressure among some users (see warning no. 10 ). similar effects on risk factors have been associated with an increased risk of heart disease. b. thromboembolism. an increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established.17, 33-51 case-control studies have estimated the relative risk to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. 34-37, 45, 46 cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases (subjects with no past history of venous thrombosis or varicose veins) and about 4.5 for new cases requiring hospitalization. 42, 47, 48 the risk of venous thromboembolic disease associated with oral contraceptives is not related to duration of use. a two- to seven-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. 38, 39 the relative risk of venous thrombosis in women who have predisposing conditions is about twice that of women without such medical conditions. 43 if feasible, oral contraceptives should be discontinued at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increased risk of thromboembolism, and also during and following prolonged immobilization. since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than 4 to 6 weeks after delivery in women who elect not to breast feed. c. cerebrovascular diseases. both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes) have been reported to be increased with oral contraceptive use, 14, 17, 18, 34, 42, 46, 52-59 although, in general, the risk was greatest among older (over 35 years), hypertensive women who also smoked. hypertension was reported to be a risk factor for both users and nonusers, for both types of strokes, while smoking increased the risk for hemorrhagic strokes. in one large study, 52 the relative risk for thrombotic stroke was reported as 9.5 times greater in users than in nonusers. it ranged from 3 for normotensive users to 14 for users with severe hypertension. 54 the relative risk for hemorrhagic stroke was reported to be 1.2 for nonsmokers who used oral contraceptives, 1.9 to 2.6 for smokers who did not use oral contraceptives, 6.1 to 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension. the risk is also greater in older women and among smokers. d. dose-related risk of vascular disease with oral contraceptives. a positive association has been reported between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. 41, 43, 53, 59-64 a decline in serum high density lipoproteins (hdl) has been reported with many progestogens. 23-31 a decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. 65 because estrogens increase hdl-cholesterol, the net effect of an oral contraceptive depends on the balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptives. the amount of both steroids should be considered in the choice of an oral contraceptive. minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. for any particular estrogen-progestogen combination, the dosage regimen prescribed should be one that contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. new acceptors of oral contraceptives should be started on preparations containing the lowest estrogen content that produces satisfactory results in the individual. e. persistence of risk of vascular disease. there are three studies that have shown persistence of risk of vascular disease for users of oral contraceptives. in a study in the united states, the risk of developing myocardial infarction after discontinuing oral contraceptives persisted for at least 9 years for women 40-49 years old who had used oral contraceptives for 5 or more years, but this increased risk was not demonstrated in other age groups. 16 another american study reported former use of oral contraceptives was significantly associated with increased risk of subarachnoid hemorrhage. 57 in another study, in great britain, the risk of developing non-rheumatic heart disease plus hypertension, subarachnoid hemorrhage, cerebral thrombosis, and transient ischemic attacks persisted for at least 6 years after discontinuation of oral contraceptives, although the excess risk was small. 14, 18, 66 it should be noted that these studies were performed with oral contraceptive formulations containing 50 mcg or more of estrogens. 2. estimates of mortality from contraceptive use. one study 67 gathered data from a variety of sources that have estimated the mortality rates associated with different methods of contraception at different ages (table 2). these estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. each method of contraception has its specific benefits and risks. the study concluded that, with the exception of oral contraceptive users 35 and older who smoke and 40 or older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. the observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's, but not reported until 1983. 67 however, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling. because of these changes in practice and, also, because of some limited new data that suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed, 48,152 the fertility and maternal health drugs advisory committee was asked to review the topic in 1989. the committee concluded that, although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures that may be necessary if such women do not have access to effective and acceptable means of contraception. therefore, the committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective. 3. carcinoma of the breast and reproductive organs. numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. while there are conflicting reports, many studies suggest that the use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer. 17, 40, 68-78 other studies, however, have reported an increased risk overall, 153-155 or in certain subgroups. in these studies, increased risk has been associated with long duration of use, use beginning at a young age, use before the first term pregnancy, use by those who had an early menarche, those who had a positive family history of breast cancer, or in nulliparas. 79-102, 151, 156-162 these risks have been surveyed in two books 163-164 and in review articles. 85, 99, 153, 165-167 some studies suggested that oral contraceptive use was associated with an increase in the risk of cervical intraepithelial neoplasia, dysplasia, erosion, carcinoma, or microglandular dysplasia in some populations of women. 17, 50, 103-115 however, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. in spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause and effect relationship has not been established. 4. hepatic neoplasia. benign hepatic adenomas and other hepatic lesions have been associated with oral contraceptive use, 116-121 although the incidence of such benign tumors is rare in the united states. indirect calculations have estimated the attributable risk to be in the range of 3.3 cases per 100,000 for users, a risk that increases after 4 or more years of use. 120 rupture of benign, hepatic adenomas or other lesions may cause death through intraabdominal hemorrhage. therefore, such lesions should be considered in women presenting with abdominal pain and tenderness, abdominal mass, or shock. about one quarter of the cases presented because of abdominal masses; up to one half had signs and symptoms of acute intraperitoneal hemorrhage. 121 diagnosis may prove difficult. studies from the u.s., 122, 150 great britain, 123, 124 and italy 125 have shown an increased risk of hepatocellular carcinoma in long-term (>8 years; relative risk of 7-20) oral contraceptive users. however, these cancers are rare in the united states, and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than 1 per 1,000,000 users. 5. risk of liver enzyme elevations with concomitant hepatitis c treatment during clinical trials with the hepatitis c combination drug regimen that contains ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir, alt elevations greater than 5 times the upper limit of normal (uln) including some cases greater than 20 times the uln, were significantly more frequent in women using ethinyl estradiol-containing medications suchs as cocs. discontinue zovia 1/35 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see contraindications ]. zovia 1/35 can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen. 6. ocular lesions. there have been reports of retinal thrombosis and other ocular lesions associated with the use of oral contraceptives. oral contraceptives should be discontinued if there is unexplained, gradual or sudden, partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or any evidence of retinal vascular lesions. appropriate diagnostic and therapeutic measures should be undertaken immediately. 7. oral contraceptive use before or during pregnancy. extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. 126, 129 the majority of recent studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, 126, 129 when the pill is taken inadvertently during early pregnancy. the administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. it is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. if the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. oral contraceptive use should be discontinued if pregnancy is confirmed. 8. gallbladder disease. earlier studies reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. 40, 42, 53, 70 more recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. 130-132 the recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower doses of estrogens and progestogens. 9. carbohydrate and lipid metabolic effects. oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. 32 this effect has been shown to be directly related to estrogen dose. 133 progestogens increase insulin secretion and create insulin resistance, the effect varying with different progestational agents. 32, 134 however, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives. some women may have persistent hypertriglyceridemia while on the pill. as discussed earlier (see warnings 1a and 1d ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users. 23-31, 135, 136 10. elevated blood pressure. an increase in blood pressure has been reported in women taking oral contraceptives 50, 53, 137-139 and this increase is more likely in older oral contraceptive users 137 and with extended duration of use. 53 data from the royal college of general practitioners 138 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens. women with a history of hypertension or hypertension-related disease, or renal disease 139 should be encouraged to use another method of contraception. if such women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. for most women, elevated blood pressure will return to normal after stopping oral contraceptives, 137 and there is no difference in the occurrence of hypertension among ever- and never-users. 140 11. headache. the onset or exacerbation of migraine or the development of headache of a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause. 12. bleeding irregularities. breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. if a pathologic basis has been excluded, time alone or a change to another formulation may solve the problem. in the event of amenorrhea, pregnancy should be ruled out. some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. 3 4 5

eping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression). ● jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems). ● unusual swelling. ● other unusual conditions. side effects of oral contraceptives 1. vaginal bleeding. spotting. this is a slight staining between your menstrual periods that may not even require a pad. some women spot even though they take their pills exactly as directed. many women spot although they have never taken the pills. spotting does not mean that your ovaries are releasing an egg. spotting may be the result of irregular pill-taking. getting back on schedule will usually stop it. if you should spot while taking the pills, you should not be alarmed, because spotting usually stops by itself within a few days. it seldom occurs after the first pill cycle. consult your doctor if spotting persists for more than a few days or if it occurs after the second cycle. unexpected (breakthrough) bleeding. unexpected (breakthrough) bleeding does not mean that your ovaries have released an egg. it seldom occurs, but when it does happen it is most common in the first pill cycle. it is a flow much like a regular period, requiring the use of a pad or tampon. if you experience breakthrough bleeding use a pad or tampon and continue with your schedule. usually your periods will become regular within a few cycles. breakthrough bleeding will seldom bother you again. consult your doctor or health care provider if breakthrough bleeding is heavy, does not stop within a week, or if it occurs after the second cycle. 2. contact lenses. if you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider. 3. fluid retention or raised blood pressure. oral contraceptives may cause edema (fluid retention), with swelling of the fingers or ankles. if you experience fluid retention, contact your doctor or health care provider. some women develop high blood pressure while on the pill, which ordinarily, but not always, returns to the original levels when the pill is stopped. high blood pressure predisposes one to strokes, heart attacks, kidney disease, and other diseases of the blood vessels. 4. melasma. a spotty darkening of the skin is possible, particularly of the face. this may persist after the pill is discontinued. 5. other side effects. other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. if any of these, or other, side effects occur, call your doctor or health care provider.

d complete your pill cycle. there is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. you should check with your doctor about risks to your unborn child of any medication taken during pregnancy. 2. breast feeding. if you are breast feeding, consult your doctor before starting oral contraceptives. some of the drug will be passed on to the child in the milk. a few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. in addition, oral contraceptives may decrease the amount and quality of your milk. if possible, do not use oral contraceptives while breast feeding. you should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. you should consider starting oral contraceptives only after you have weaned your child completely. 3. laboratory tests. if you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. certain blood tests may be affected by birth control pills. 4. drug interactions. certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital) and phenytoin (dilantin is one brand of this drug), phenylbutazone (butazolidin is one brand), rezulin (troglitazone) a hypoglycemic, and possibly certain antibiotics. you may need to use additional contraception when you take drugs that can make oral contraceptives less effective. oral contraceptives may have an influence upon the way other drugs act. check with your doctor if you are taking any other drugs while you are on the pill. how to take the pill important points to remember before you start taking your pills: 1. be sure to read these directions: ● before you start taking your pills. ● anytime you are not sure what to do. 2. the right way to take the pill is to take one pill every day at the same time. if you miss pills you could get pregnant. this includes starting the pack late. the more pills you miss, the more likely you are to get pregnant. 3. many women have spotting or light bleeding, or may feel sick to their stomach during the first 1-3 packs of pills. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if it doesn't go away, check with your doctor or clinic. 4. missing pills can also cause spotting or light bleeding, even when you make up these missed pills. on the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5. if you have vomiting or diarrhea, for any reason, or if you take some medicines, including some antibiotics, your pills may not work as well. use a backup method (such as condoms, foam, or sponge) until you check with your doctor or clinic. 6. if you have trouble remembering to take the pill, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 7. if you have any questions or are unsure about the information in this leaflet, call your doctor or clinic. before you start taking your pills 1. decide what time of day you want to take your pill. it is important to take it at about the same time every day. 2. look at your pill pack: your tablet dispenser consists of a plastic compact and a blister pack containing 28 pills. the 28 tablets are arranged in four numbered rows with the days of the week embossed on the plastic compact just above the tablets, starting with sunday on the left. the zovia 1/35 tablet dispenser contain 21 pale pink active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 white placebo (inactive) tablets (see graphic below). the 28-pill pack has 21 pale pink "active" pills (with hormones) to take for 3 weeks, followed by 1 week of reminder white placebo pills (without hormones). to remove a pill press down on it with the flat of your finger. the pill will drop through a hole in the bottom of the dispenser. 3. also find: ● where on the pack to start taking pills. ● in what order to take the pills (left to right). begin the 28-pill pack with the first pill in row 1 and continue across row 1 (start 1). repeat for row 2, row 3, and finally row 4. take all "active" pills (pale pink) before starting row 4. 4. be sure you have ready at all times: ● another kind of birth control (such as condoms, foam, or sponge) to use as a backup in case you miss pills. ● an extra, full pill pack. when to start the first pack of pills you have a choice of which day to start taking your first pack of pills. zovia 1/35 is available in a compact blister card preset for a sunday start with the days of the week embossed on the plastic compact just above the tablets, starting with sunday on the left. day 1 start stickers are also provided. decide with your doctor or clinic which is the best day for you. pick a time of day which will be easy to remember. day 1 start: 1. pick the day label sticker that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). 2. place this day label sticker in the tablet dispenser over the area that has the days of the week (starting with sunday) imprinted on the plastic compact. note: if the first day of your period is a sunday, you can skip steps #1 and #2. 3. take the first "active" pill (pale pink) of the first pack during the first 24 hours of your period. 4. you will not need to use a backup method of birth control, since you are starting the pill at the beginning of your period. sunday start: 1. take the first "active" pill (pale pink) of the first pack on the sunday after your period starts , even if you are still bleeding. if your period begins on sunday, start the pack that same day. 2. use another method of birth control as a backup method if you have sex anytime from the sunday you start your first pack until the next sunday (7 days). condoms, foam, or the sponge are good backup methods of birth control. what to do during the month 1. take one pill at the same time every day until the pack is empty. ● do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). ● do not skip pills even if you do not have sex very often. 2. when you finish a pack or switch your brand of 28-day pills: start the next pack on the day after your last "reminder" pill. do not wait any days between 28-day packs. what to do if you miss pills if you miss 1 "active" pill (pale pink): 1. 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. 2. you do not need to use a backup birth control method if you have sex. if you miss 2 "active" pills (pale pink) in a row in week 1 or week 2 of your pack: 1. take 2 pills on the day you remember and 2 pills the next day. 2. then take 1 pill a day until you finish the pack. 3. you may become pregnant if you have sex in the 7 days after you miss pills. you must use another birth control method (such as condoms, foam, or sponge) as a backup for those 7 days. if you miss 2 "active" pills (pale pink) in a row in the 3rd week: 1. 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. 2. 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 doctor or clinic because you might be pregnant. 3. you may become pregnant if you have sex in the 7 days after you miss pills. you must use another birth control method (such as condoms, foam, or sponge) as a backup for those 7 days. if you miss 3 or more "active" pills (pale pink) in a row (during the first 3 weeks): 1. if you are a day 1 starter: throw out the rest of the pill pack and start a new pack of pills 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. 2. 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 doctor or clinic because you might be pregnant. 3. you may become pregnant if you have sex in the 7 days after you miss pills. you must use another birth control method (such as condoms, foam, or sponge) as a backup for those 7 days. a reminder: if you forget any of the 7 white "reminder" pills in week 4: ● throw away the pills you missed. ● keep taking 1 pill each day until the pack is empty. ● you do not need a backup method. finally, if you are still not sure what to do about the pills you have missed ● use a backup method of birth control anytime you have sex. ● keep taking one "active" pill each day until you can reach your doctor or clinic. pregnancy due to pill failure the incidence of pill failure resulting in pregnancy is approximately 1% (i.e., one pregnancy per 100 women per year) if taken every day as directed, but, because some women fail to follow the daily schedule, more typical failure rates are about 3%. if you become pregnant you should discuss your pregnancy with your doctor. pregnancy after stopping the pill there may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. it may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. there does not appear to be any increase in birth defects in newborn babies when pregnancy occurs after stopping the pill. overdosage serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. overdosage may cause nausea and withdrawal bleeding in females. in case of overdosage, contact your health care provider, pharmacist or poison control center. other information your health care provider will take a medical and family history before prescribing oral contraceptives and will also examine you. the physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. you should be re-examined at least once a year. certain health problems or conditions in your medical or family history may require that your health care provider see you more frequently while you are taking the pill. be sure to keep all appointments with your health care provider because this is a time to determine if there are early signs of side effects of oral contraceptive use. do not use the drug for any condition other than the one for which it was prescribed. this drug has been prescribed specifically for you; do not give it to others who may want birth control pills. this product (like all oral contraceptives) is intended to prevent pregnancy. it does not protect against transmission of hiv (aids) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis b, and syphilis. health benefits from oral contraceptives in addition to preventing pregnancy, use of oral contraceptives may provide certain benefits. they are: ● menstrual cycles may become more regular ● blood flow during menstruation may be lighter and less iron may be lost. therefore, anemia due to iron deficiency is less likely to occur ● pain or other symptoms during menstruation may be encountered less frequently ● ectopic (tubal) pregnancy may occur less frequently ● noncancerous cysts or lumps in the breast may occur less frequently ● acute pelvic inflammatory disease may occur less frequently ● fibroids of the uterus (womb) may occur less frequently ● oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus (womb) if you want more information about birth control pills, ask your doctor or pharmacist. they have a more technical leaflet called the professional labeling, which you may wish to read. the professional labeling is also published in a book entitled physicians' desk reference, available in many book stores and public libraries. keep this and all drugs out of the reach of children. be certain to read new revisions of this leaflet. to report suspected adverse reactions, contact mayne pharma toll-free at 1-844-825-8500 or fda at 1-800-fda-1088 or www.fda.gov/medwatch . distributed by: mayne pharma greenville, nc 27834 i 0134 iss. 07/2020 rev.a 10 11 12

pink) is taken on that day. with either a day 1 start or sunday start, 1 tablet (pale pink) is taken each day at the same time for 21 days. then the white tablets are taken for 7 days, whether bleeding has stopped or not. after all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day. special notes spotting, breakthrough bleeding, or nausea. if spotting (bleeding insufficient to require a pad), breakthrough bleeding (heavier bleeding similar to a menstrual flow), or nausea occurs the patient should continue taking her tablets as directed. the incidence of spotting, breakthrough bleeding or nausea is minimal, most frequently occurring in the first cycle. ordinarily spotting or breakthrough bleeding will stop within a week. usually the patient will begin to cycle regularly within two or three courses of tablet-taking. in the event of spotting or breakthrough bleeding organic causes should be borne in mind. (see warning no. 12 .) missed menstrual periods. withdrawal flow will normally occur 2 or 3 days after the last active tablet is taken. failure of withdrawal bleeding ordinarily does not mean that the patient is pregnant, providing the dosage schedule has been correctly followed. (see warning no. 7. ) if the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period, and oral contraceptives should be withheld until pregnancy has been ruled out. if the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. the first intermenstrual interval after discontinuing the tablets is usually prolonged; consequently, a patient for whom a 28-day cycle is usual might not begin to menstruate for 35 days or longer. ovulation in such prolonged cycles will occur correspondingly later in the cycle. post-treatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets. (see warning no. 12 .) missed tablets. if a woman misses taking one active tablet, the missed tablet should be taken as soon as it is remembered. in addition, the next tablet should be taken at the usual time. if two consecutive active tablets are missed in week 1 or week 2 of the dispenser, the dosage should be doubled for the next 2 days. the regular schedule should then be resumed, but an additional method of protection must be used as backup for the next 7 days if she has sex during that time or she may become pregnant. if two consecutive active tablets are missed in week 3 of the dispenser or three consecutive active tablets are missed during any of the first 3 weeks of the dispenser, direct the patient to do one of the following: day 1 starters should discard the rest of the dispenser and begin a new dispenser that same day; sunday starters should continue to take 1 tablet daily until sunday, discard the rest of the dispenser and begin a new dispenser that same day. the patient may not have a period this month; however, if she has missed two consecutive periods, pregnancy should be ruled out. an additional method of protection must be used as a backup for the next 7 days after the tablets are missed if she has sex during that time or she may become pregnant. while there is little likelihood of ovulation if only one active tablet is missed, the possibility of spotting or breakthrough bleeding is increased and should be expected if two or more successive active tablets are missed. however, the possibility of ovulation increases with each successive day that scheduled active tablets are missed. if one or more placebo tablets of zovia 1/35 are missed, the schedule should be resumed on the eighth day after the last pale pink colored tablet was taken. omission of placebo tablets in the 28-tablet courses does not increase the possibility of conception provided that this schedule is followed.

spotting ● change in menstrual flow ● amenorrhea during or after use ● temporary infertility after discontinuation of use ● edema ● chloasma or melasma, which may persist ● breast changes: tenderness, enlargement, secretion ● change in weight (increase or decrease) ● change in cervical erosion or secretion ● diminution in lactation when given immediately postpartum ● cholestatic jaundice ● migraine ● rash (allergic) ● mental depression ● reduced tolerance to carbohydrates ● vaginal candidiasis ● change in corneal curvature (steepening) ● intolerance to contact lenses the following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: ● premenstrual syndrome ● cataracts ● changes in appetite ● cystitis-like syndrome ● headache ● nervousness ● dizziness ● hirsutism ● loss of scalp hair ● erythema multiforme ● erythema nodosum ● hemorrhagic eruption ● vaginitis ● porphyria ● impaired renal function ● hemolytic uremic syndrome ● acne ● changes in libido ● colitis ● budd-chiari syndrome ● endocervical hyperplasia or ectropion