DailyMed Label: DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

DailyMed Label: desogestrel and ethinyl estradiol and ethinyl estradiol

2024

DailyMed Prescription

desogestrel and ethinyl estradiol and ethinyl estradiol

desogestrel and ethinyl estradiol and ethinyl estradiol

Naari Pte. Limited

NDC: 79929-020

NDC: 79929-020

NDC: 79929-020

NDC: 79929-020

NDC: 79929-020

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen of 21 white to off white round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include lactose monohydrate, pregelatinized starch (Maize starch), povidone K-30, vitamin E, stearic acid, colloidal anhydrous silica, purified talc, magnesium stearate, Hypromellose, Polyethylene glycol and followed by 2 inert light-green round tablets with the following inactive ingredients /lactose monohydrate, pregelatinized starch (Starch 1500), colloidal anhydrous silica, talc, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD&C blue no. 1 aluminium lake, D&C yellow no. 10 aluminium lake, FD&C yellow no. 6 aluminium lake. Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP also contains 5 yellow coloured round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include lactose monohydrate, pregelatinized starch (Maize starch), povidone K-30, vitamin E, stearic acid, colloidal anhydrous silica, purified talc, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, D&C yellow no. 10 aluminium lake, FD&C yellow no. 6 aluminium lake. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows: image description

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women  Continuing Use at  One Year a Method (1) Typical Use b (2) Perfect Use c (3) (4) Chance d 85 85 Spermicides e 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal f 2 Post-Ovulation 1 Withdrawal 19 4 Cap g Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm g 20 6 56 Condom h Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Adapted from Hatcher et al., 1998, ref #1. a)  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b)  Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 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.

To achieve maximum contraceptive effectiveness,Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP must be taken exactly as directed and at intervals not exceeding 24 hours. Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP may be initiated using either a Sunday start or a Day 1 start. NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP should be considered. The use of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for Nursing mothers ). If the patient starts on Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days. When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 light-green (inert) tablet daily for 2 days and 1 yellow (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28 tablet regimen on the next day (Sunday) after taking the last yellow tablet. [If switching from a Sunday start oral contraceptive, the first Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP should be taken on the second Sunday after the last tablet of a 21 day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. Counting the first day of menstruation as “Day 1”, tablets are taken without interruption as follows: One white tablet daily for 21 days, one light-green (inert) tablet daily for 2 days followed by 1 yellow (ethinyl estradiol) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28 tablet regimen on the next day after taking the last yellow tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or if the patient misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease. Use of oral contraceptives in the event of a missed menstrual period: 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 oral contraceptive use should be discontinued until pregnancy is ruled out. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

Oral contraceptives should not be used in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Known or suspected pregnancy Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ).

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines (72). Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ). Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered. Other binding proteins may be elevated in serum. Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged. High-density lipoprotein cholesterol (HDL-C) and triglycerides may be increased, while low-density lipoprotein cholesterol (LDL-C) and total cholesterol (Total-C) may be decreased or unchanged. Glucose tolerance may be decreased. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. See WARNINGS . Discontinue Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP if pregnancy occurs because there is no reason to use COCs in pregnancy. See WARNINGS section. Small amounts of oral contraceptive steroids have been identified in the human milk and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child. Safety and efficacy of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in 28 days regimen of blister pack (NDC 79929-020-05) as follows: 21 White to off white, round, biconvex, film coated tablets, debossed with FT1 on one side and plain on other side containing 0.15 mg desogestrel and 0.02 mg ethinyl estradiol, 2 light-green coloured, round, biconvex, film coated tablets debossed with FT3 on one side and plain on other side containing inert ingredients and 5 Yellow coloured, round, biconvex, film coated tablets, debossed with FT2 on one side and plain on other side containing 0.01 mg ethinyl estradiol. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. The blister packs are available in boxes of 3.

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Receptor binding studies, as well as studies in animals, have shown that etonogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity (91, 92). The relevance of this latter finding in humans is unknown. Pharmacokinetics Absorption Desogestrel is rapidly and almost completely absorbed and converted into etonogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of desogestrel compared to a solution, as measured by serum levels of etonogestrel, is approximately 100%. Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP provide two different regimens of ethinyl estradiol; 0.02 mg in the combination tablet [white] as well as 0.01 mg in the yellow tablet. Ethinyl estradiol is rapidly and almost completely absorbed. After a single dose of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP combination tablet [white], the relative bioavailability of ethinyl estradiol is approximately 93% while the relative bioavailability of the 0.01 mg tablet [yellow] is 99%. The effect of food on the bioavailability of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP following oral administration has not been evaluated. The pharmacokinetics of etonogestrel and ethinyl estradiol following multiple dose administration of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP were determined during the third cycle in 17 subjects. Plasma concentrations of etonogestrel and ethinyl estradiol reached steady state by Day 21. The AUC(024) for etonogestrel at steady state on Day 21 was approximately 2.2 times higher than AUC(024) on Day 1 of the third cycle. The pharmacokinetic parameters of etonogestrel and ethinyl estradiol during the third cycle following multiple dose administration of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are summarized in Table I. TABLE I: MEAN (SD) PHARMACOKINETIC PARAMETERS OF Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP OVER A 28 DAY DOSING PERIOD IN THE THIRD CYCLE (n = 17).  Etonogestrel  Day Dose a  mg  C max pg/mL T max h t 1/2  h  AUC 0-24 pg/mL.hr CL/F L/h   1  0.15  2503.6(987.6) 2.4 (1.0)  29.8(16.3)  17,832(5674) 5.4(2.5)  21  0.15   4091.2(1186.2)  1.6(0.7) 27.8(7.2)   39,391(12,134)  4.4(1.4) a) Desogestrel Ethinyl Estradiol   Day   Dose a mg  C max pg/mL  Tmax h  t 1/2 h AUC 0-24 pg/mL.hr  CL/F L/h 1   0.02   51.9(15.4)  2.9(1.2)  16.5 (4.8)  566 (173) a 25.7 (9.1)  21  0.02  62.2 (25.9)  2.0(0.8)   23.9 (25.5)  597 (127) a  35.1 (8.2) 24  0.01  24.6(10.8)  2.4(1.0)   18.8 (10.3)  246 (65)  43.6 (12.2) 28  0.01  35.3(27.5)  2.1(1.3)   18.9 (8.3)  312 (62)  33.2 (6.6)  C max – measured peak concentration        T max – observed time of peak concentration  t 1/2 – elimination half-life, calculated by 0.693/K elim  AUC 0-24 – area under the concentration-time curve calculated by the linear trapezoidal rule (Time 0 to 24 hours)  CL/F – apparent clearance a) n=16 Distribution Etonogestrel, the active metabolite of desogestrel, was found to be 99% protein bound, primarily to sex hormone-binding globulin (SHBG). Ethinyl estradiol is approximately 98.3% bound, mainly to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Desogestrel, in combination with ethinyl estradiol, does not counteract the estrogen-induced increase in SHBG, resulting in lower serum levels of free testosterone (96 to 99). Metabolism Desogestrel: Desogestrel is rapidly and completely metabolized by hydroxylation in the intestinal mucosa and on first pass through the liver to etonogestrel. Other metabolites (i.e., 3-OH-desogestrel, 3-OH-desogestrel, and 3-OH-5-H-desogestrel) with no pharmacologic actions also have been identified and these metabolites may undergo glucuronide and sulfate conjugation. Ethinyl Estradiol: Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol escaping gut wall conjugation undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Sulfate and glucuronide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation. Excretion Etonogestrel and ethinyl estradiol are excreted in urine, bile, and feces. At steady state, on Day 21, the elimination half-life of etonogestrel is 27.8 ± 7.2 hours and the elimination half-life of ethinyl estradiol for the combination tablet is 23.9 ± 25.5 hours. For the 0.01 mg ethinyl estradiol tablet [yellow], the elimination half-life at steady state, Day 28, is 18.9 ± 8.3 hours. Special Populations Race There is no information to determine the effect of race on the pharmacokinetics of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP. Hepatic Insufficiency No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP. Renal Insufficiency No formal studies were conducted to evaluate the effect of renal disease on the disposition of Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP. Drug-Drug Interactions Interactions between desogestrel/ethinyl estradiol and other drugs have been reported in the literature. No formal drug-drug interaction studies were conducted (see PRECAUTIONS).

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Oral contraceptives, also known as birth control pills or the pill, are taken to prevent pregnancy, and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 5% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: smoke have high blood pressure, diabetes, high cholesterol have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors. Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, headache, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: Blood clots in the legs (thrombophlebitis) or lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes, and subsequent serious medical consequences. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. High blood pressure, although blood pressure usually returns to normal when the pill is stopped. The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness. There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers. Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your doctor or healthcare provider. Your doctor or healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and your doctor or healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your doctor or healthcare provider. 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. INSTRUCTIONS TO PATIENTS HOW TO TAKE THE PILL IMPORTANT POINTS TO REMEMBER BEFORE  YOU START TAKING YOUR PILLS: BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 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. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 TO 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 doesnt go away, check with your doctor or healthcare provider. 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. 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 back-up method (such as condoms, foam, or sponge) until you check with your doctor or healthcare provider. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider about how to make pill-taking easier or about using another method of birth control. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or healthcare provider. BEFORE  YOU START TAKING YOUR PILLS DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. LOOK AT YOUR PILL PACK: IT WILL HAVE 28 PILLS: This  28 pill pack  has 26 active [white and yellow] pills (with hormones) and 2 inactive [light-green] pills (without hormones). ALSO FIND: 1) where on the pack to start taking the pills, 2) in what order to take the pills (follow the arrows) and 3) the week numbers as shown in the picture below. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or sponge) to use as a back-up 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. Decide with your doctor or healthcare provider which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START Pick the day label strip 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). Place this day label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted on the blister card. Note: If the first day of your period is a Sunday, you can skip steps #1 and #2. Take the first "active" [white] pill of the first pack during the  first 24 hours of your period . You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period. SUNDAY START Take the first active [white] pill 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. Use another method of birth control  as a back-up 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 back-up methods of birth control. WHAT TO DO DURING THE MONTH 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. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS: 21 pills :  Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21 day packs. 28 pills :  Start the next pack on the day after your last pill. Do not wait any days between packs. WHAT TO DO IF YOU MISS PILLS If you  MISS 1  active [white] pill: Take it as soon as you remember. Take the next pill at your regular time. This means you take 2 pills in 1 day. You do not need to use a back-up birth control method if you have sex. If you  MISS 2  active [white] pills in a row in  WEEK 1 OR WEEK 2  of your pack: Take 2 pills on the day you remember and 2 pills the next day. Then take 1 pill a day until you finish the pack. 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 back-up method for those 7 days. If you  MISS 2  active [white] pills in a row in  WEEK 3: 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 doctor or healthcare provider because you might be pregnant. 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 back-up method for those 7 days. If you  MISS 3 OR MORE  active [white] pills in a row (during the first 3 weeks): 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 doctor or healthcare provider because you might be pregnant. 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 back-up method for those 7 days. A REMINDER FOR THOSE ON 28 DAY PACKS If you forget any of the 2 [light-green] or 5 [yellow] 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 back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE ACTIVE [WHITE] PILL EACH DAY until you can reach your doctor or healthcare provider. 1 1

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