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âšī¸Common side effects
Postmarketing Experience: Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1).
â ī¸Serious risks
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral-contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.
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Levonorgestrel + Ethinyl Estradiol (Enpresse âĸ [Generic for Triphasil]) Prices
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Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral-contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 1.PHYSICAL EXAMINATION AND FOLLOW-UP A periodic history and physical examination is appropriate for all women, 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. 2.LIPID DISORDERS 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. (See "Warnings," 1d.) 3.LIVER FUNCTION 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. 4.FLUID RETENTION 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. 5.EMOTIONAL DISORDERS Patients becoming significantly depressed while take oral contraceptives should stop the medication and use an alternative method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 6.HEREDITARY ANGIOEDEMA In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 7.CONTACT LENSES Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 8.DRUG INTERACTIONS Concomitant Use with HCV Combination Therapy Liver Enzyme Elevation Do not co-administer levonorgestrel and ethinyl estradiol tablets 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). 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, and possibly with griseofulvin, ampicillin, and tetracyclines. 9.INTERACTIONS WITH LABORATORY TESTS Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives: a.Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. b.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. c.Other binding proteins may be elevated in serum. d.Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged. e.Triglycerides may be increased. f.Glucose tolerance may be decreased. g.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. 10.CARCINOGENESIS See "Warnings" section. 11.PREGANANCY See "Contraindications" and "Warnings" sections. 12.NURSING MOTHERS Small amounts of oral-contraceptive steroids have been identified in the milk of nursing mothers, 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. 13.PEDIATRIC USE Safety and efficacy of levonorgestrel and ethinyl estradiol tablets 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 users 16 and older. Use of this product before menarche is not indicated.
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Postmarketing Experience: Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. RR = relative risk; OR = odds ratio; HR = hazard ratio. "ever COC" are females with current or past COC use; "never COC use" are females that never used COCs.
Any woman who considers using oral contraceptives (the birth-control pill or the pill) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health-care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health-care provider s advice with regard to regular check-ups while you are on the pill.
Oral contraceptives or "birth-control pills" or "the pill" are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1.0 % when used perfectly, without missing any pills. Typical failure rates are less than 3.0% per year. The chance of becoming pregnant increases with each missed pill during the menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during first year of use are as follows: TABLE: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not available Method Perfect use Average use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera (Injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (female) without spermicide 5 21 Cervical cap Never given birth 9 20 Given birth 26 40 Vaginal sponge Never given birth 9 20 Given birth 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1 to 9* 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85
Tell your health-care provider if you or any family member has ever had: Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram. Diabetes. Elevated cholesterol or triglycerides. High blood pressure. Migraine or other headaches or epilepsy. Mental depression. Gallbladder, heart, or kidney disease. History of scanty or irregular menstrual periods. Hereditary angioedema. Also, be sure to inform your doctor or health-care provider if you smoke or are on any medications. Women with any of these conditions should be checked often by their health-care provider if they choose to use oral contraceptives.
1.Risk of developing blood clots Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can be fatal. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby or a midtrimester pregnancy termination. It is advisable to wait for at least four weeks after delivery if you are not breast-feeding. If you are breast-feeding, you should wait until you have weaned your child before using the pill. (See also the section on breast feeding in "General Precautions.") 2.Heart attacks and Strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and use oral contraceptives greatly increase the chances of developing and dying of heart disease. 3.Gallbladder disease Oral-contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. 4.Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in two studies in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancers from using the pills is thus even rarer. 5. Risk of Cancer It is not known if hormonal birth control pills causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. 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.
All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table. *Deaths are birth related **Deaths are method related Annual Number of Birth-Related or Method-Related Deaths Associated With Control of Fertility per 100,000 Nonsterile Women, by Fertility-Control Method According to Age Method of control and outcome 15 to 19 20 to 24 25 to 29 30 to 34 35 to 39 40 to 44 No fertility-control 7.0 7.4 9.1 14.8 25.7 28.2 methods* Oral contraceptives 0.3 0.5 0.9 1.9 13.8 31.6 nonsmoker** Oral contraceptives 2.2 3.4 6.6 13.5 51.1 117.2 smoker** IUD** 0.8 0.8 1.0 1.0 1.4 1.4 Condom* 1.1 1.6 0.7 0.2 0.3 0.4 Diaphragm/spermicide* 1.9 1.2 1.2 1.3 2.2 2.8 Periodic abstinence* 2.5 1.6 1.6 1.7 2.9 3.6 In the above table, the risk of death from any birth-control method is less than the risk of childbirth, except for oral-contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, except for those women over the age of 40, when the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who don t smoke should not take oral contraceptives is based on information from older high-dose pills and on less-selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral-contraceptive use by healthy, nonsmoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest-dose pill that is effective.
If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately: Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung). Pain in the calf (indicating a possible clot in the leg). Crushing chest pain or heaviness in the chest (indicating a possible heart attack). Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke). Sudden partial or complete loss of vision (indicating a possible clot in the eye). Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health-care provider to show you how to examine your breasts). Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor). Difficulty in sleeping, 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).
1. Vaginal Bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral-contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or health-care provider. 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 Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or health-care provider. 4. Melasma A spotty darkening of the skin is possible, particularly of the face. 5. Other Side Effects Other side effects may include nausea, breast tenderness, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, inflammation of the pancreas, and allergic reactions. If any of these side effects bother you, call your doctor or health-care provider. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or you can visit the Lupin website at www.lupinpharmaceuticals.com
1. Missed periods and use of oral contraceptives before or during early pregnancy There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your health-care provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant. Check with your health-care provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. 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 studies have not been confirmed. 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. While 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 schedule 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), and possibly certain antibiotics. You may need to use an additional method of contraception during any cycle in which you take drugs that can make oral contraceptives less effective.
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. IMPORTANT POINTS TO REMEMEBER 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 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 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. Use a back-up 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: The 28 -pill pack has 21 "active" light blue, white to off white or pink pills (with hormones) to take for 3 weeks, followed by 1 week of reminder orange pills (without hormones). 3. ALSO FIND: 1) where on the pack to start taking pills, and 2) in what order to take the pills (follow the arrows). 4. 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 clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: 1. Take the first "active" light blue pill of the first pack during the first 24 hours of your period. 2. 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: 1. Take the first "active" light blue 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. 2. 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: 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 PILLS: 28 pills: Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs. WHAT TO DO IF YOU MISS PILLS The pill may not be as effective if you miss light blue, white to off white or pink "active" pills, and particularly if you miss the first few blue or the last few pink "active" pills in a pack. If you MISS 1 light blue, white to off white or pink "active" pill: 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. You do not need to use a back-up birth-control method if you have sex. If you MISS 2 light blue, white to off white or pink "active" 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, spermicide, or sponge) as a back-up for those 7 days. If you MISS 2 light blue, white to off white or pink "active" pills 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, spermicide, or sponge) as a back-up for those 7 days. If you MISS 3 OR MORE light blue, white to off white or pink "active" pills 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 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, spermicide, or sponge) as a back-up for those 7 days. A REMINDER: If you forget any of the 7 orange "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 back-up method if you start your next pack on time.
Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE 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 less than 1.0% if taken every day as directed, but more typical failure rates are less than 3.0%. If failure does occur, the risk to the fetus is minimal. RISKS TO THE FETUS If you do become pregnant while using oral contraceptives, the risk to the fetus is small, on the order of no more than one per thousand. You should, however, discuss the risks to the developing child with your doctor. Pregnancy after stopping of 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 soon 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 or pharmacist. Other information Your health-care 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 the health-care provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your health-care provider if there is a family history of any of the conditions listed previously in this leaflet. 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.
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. Ovarian cysts may occur 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. 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. 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.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05 mg/0.03 mg, 0.075 mg/0.04 mg and 0.125 mg/0.03 mg Rx Only NDC 68180-857-71 Blister Label: 28 Tablets Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05 mg/0.03 mg, 0.075 mg/0.04 mg and 0.125 mg/0.03 mg Rx Only NDC 68180-857-73 Carton Label: 3 Blisters of 28 Tablets Each
