Label: LUTERA- levonorgestrel and ethinyl estradiol kit

Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

C 21H 28O 2 M.W. 312.45	C 20H 24O 2 M.W. 296.4

Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Oral contraceptives are highly effective. Table 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, the IUD, and Norplant ®System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.

Lutera is contraindicated in females who are known to have or develop the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A history of deep-vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or past history)
• Valvular heart disease with thrombogenic complications
• Thrombogenic rhythm disorders
• Hereditary or acquired thrombophilias
• Major surgery with prolonged immobilization
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Uncontrolled hypertension
• 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, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any of the components of Lutera
• 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).

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see CONTRAINDICATIONS).

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral-contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohorts studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral-contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

• Increase menstrual cycle regularity
• Decreased blood loss and decreased incidence of iron-deficiency anemia
• Decreased incidence of dysmenorrhea

Effects related to inhibition of ovulation:

• Decreased incidence of functional ovarian cysts
• Decreased incidence of ectopic pregnancies

Effects from long-term use:

• Decreased incidence of fibroadenomas and fibrocystic disease
• Decreased incidence of acute pelvic inflammatory disease
• Decreased incidence of endometrial cancer
• Decreased incidence of ovarian cancer

To achieve maximum contraceptive effectiveness, Lutera® (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lutera is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Lutera tablets be taken at the same time each day.

The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed.

Lutera® tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser (75907-079-28), arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:

21 active tablets: white, round tablet debossed with "949" on one side.

7 inert tablets: peach, round tablet debossed with "P1" on one side.

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

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 approximately 1.0% (1 pregnancy per 100 women per year of use) when used without missing any pills. The average failure rate of large numbers of pill users is approximately 5% (5 pregnancies per 100 women per year of use) 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 or death. The risks associated with taking oral contraceptives increase significantly if you:

• smoke.
• have high blood pressure, diabetes, high cholesterol, or a tendency to form blood clots.
• have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, malignant or benign liver tumors, or major surgery with prolonged immobilization.
• have headaches with neurological symptoms

You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral-contraceptive use are age 40 in healthy, nonsmoking women, there are also greater potential health risks associated with pregnancy in older women.

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, 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 do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), blockage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack and 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. Women with migraine also may be at increased risk of stroke with pill use.
2. 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.
3. 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 health-care 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, herbal preparations containing St. John's Wort (Hypericum perforatum), and HIV/AIDS drugs 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 uses 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.

Taking the pill provides some important noncontraceptive 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 health-care provider. 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 while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health-care provider.

For more information, call 1-888-375-3784.

HOW TO TAKE LUTERA

IMPORTANT POINTS TO REMEMBER

BEFOREYOU START TAKING LUTERA:

1. BE SURE TO READ THESE DIRECTIONS:
   Before you start taking LUTERA.
   And
   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. See " WHAT TO DO IF YOU MISS PILLS" below.
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 LUTERA. The problem will usually go away. If it doesn't go away, check with your health-care provider.
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 (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.
   Use a back-up nonhormonal method (such as condoms or spermicide) until you check with your health-care provider.
6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your health-care provider 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 health-care provider.

BEFOREYOU START TAKING LUTERA

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 pill pack has 21 "active" white pills (with hormones) to take for 3 weeks, followed by 1 week of reminder peach pills (without hormones).
3. FIND:
   1. where on the pack to start taking pills, and
   2. in what order to take the pills (follow the arrow).
   

4. BE SURE YOU HAVE READY AT ALL TIMES:
   ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up in case you miss pills.
   AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRSTPACK OF PILLS

You have a choice of which day to start taking your first pack of pills.

Decide with your health-care 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. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the tablet dispenser.

Note: if the first day of your period is a Sunday, you can skip step #1.

• 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 nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

SUNDAY START

1. 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.
2. Use a nonhormonal method of birth control(such as condoms or spermicide) as a backup method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

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:
   Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS

If your previous brand had 21 pills:Wait 7 days to start taking LUTERA. You will probably have your period during that week. Be sure that no more than 7 days pass between the 21-day pack and taking the first white LUTERA pill ("active" with hormone).

If your previous brand had 28 pills:Start taking the first white LUTERA pill ("active" with hormone) on the day after your last reminder pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

LUTERA may not be as effective if you miss white "active" pills, and particularly if you miss the first few or the last few white "active" pills in a pack.

If you MISS 1white "active" pill:

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 COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2white "active" pills in a row in WEEK 1 OR WEEK 2of 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 COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2white "active" pills in a row in THE 3 rdWEEK:

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 that is expected.
   However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
3. You COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 3 OR MOREwhite "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 that is expected.
   However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
3. You COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you forget any of the 7 peach "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 nonhormonal birth-control method if you start your next pack on time.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your health-care provider.

BIRTH CONTROL AFTER STOPPING THE PILL

If you do not wish to become pregnant after stopping the pill, speak to your health-care provider about another method of birth control.

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

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.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives or "birth-control pills" or "the pill" are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is approximately 1% per year (1 pregnancy per 100 women per year of use). Typical failure rates are approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. The chance of becoming pregnant increases with each missed pill during each 28-day cycle of use.

In comparison, average failure rates for other methods of birth control during the first year of use are as follows:

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

Some women should not use the pill. For example, you should not use the pill if you have any of the following conditions:

• History of heart attack or stroke.
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes.
• A history of blood clots in the deep veins of your legs.
• Chest pain (angina pectoris).
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, or certain hormonally-sensitive cancers.
• Unexplained vaginal bleeding (until a diagnosis is reached by your health-care provider).
• Liver tumor (benign or cancerous) or acute liver disease.
• Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood.
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill
• Known or suspected pregnancy
• A need for surgery with prolonged bedrest.
• Heart valve or heart rhythm disorders that may be associated with formation of blood clots.
• Diabetes affecting your circulation.
• Headaches with neurological symptoms.
• Uncontrolled high blood pressure.
• Allergy or hypersensitivity to any of the components of LUTERA (levonorgestrel and ethinyl estradiol tablets).

Tell your health-care provider if you have ever had any of these conditions. Your health-care provider can recommend another method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

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.
• A tendency to form blood clots.
• Migraine or other headaches or epilepsy.
• Depression.
• Gallbladder, liver, heart, or kidney disease.
• History of scanty or irregular menstrual periods.

Women with any of these conditions should be checked often by their health-care provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or health-care provider if you smoke or are on any medications.

Although cardiovascular disease risks may be increased with oral contraceptive use in healthy, non-smoking women over 40 (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

RISKS OF TAKING 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 cause death or serious disability. 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.

Users of combined oral contraceptives have a higher risk of developing blood clots compared to non-users. This risk is highest during the first year of combination oral-contraceptive use.

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 While breast-feeding GENERAL PRECAUTIONS.)

The risk of blood clots is greater in users of combination oral contraceptives compared to nonusers. This risk may be higher in users of high-dose pills (those containing 50 mcg or more of estrogen) and may also be greater with longer use. In addition, some of these increased risks may continue for a number of years after stopping combination oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of combination oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages.

The excess risk of blood clots is highest during the first year a woman ever uses a combined oral contraceptive. This increased risk is lower than blood clots associated with pregnancy. The use of combination oral contraceptives also increases the risk of other clotting disorders, including heart attack and stroke. Blood clots in veins cause death in 1% to 2% of cases. The risk of clotting is further increased in women with other conditions. Examples include: smoking, high blood pressure, abnormal lipid levels, certain inherited or acquired clotting disorders, obesity, surgery or injury, recent delivery or second trimester abortion, prolonged inactivity or bed rest. If possible, combination oral contraceptives should be stopped before surgery and during prolonged inactivity or bedrest.

Cigarette smoking increases the risk of serious cardiovascular events. This risk increases with age and amount of smoking and is quite pronounced in women over 35. Women who use combination oral contraceptives should be strongly advised not to smoke. If you smoke you should talk to your health care professional before taking combination oral contraceptives.

2. Heart attacks and strokes

Oral contraceptives may increase the tendency to develop strokes or transient ischemic attacks (blockage 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 the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.

Women with migraine (especially migraine/headache with neurological symptoms) who take oral contraceptives also may be at higher risk of stroke and must not use combination oral contraception (see section WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES).

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. Oral contraceptives may worsen existing gallbladder disease or accelerate the development of gallbladder disease in women previously without symptoms.

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 cancer from using the pill is thus even rarer.

5. Risk of Cancer

It is not known if hormonal birth control pills cause 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.

6. Lipid Metabolism and Pancreatitis

There have been reports of increases of blood cholesterol and triglycerides in users of combination oral contraceptives. Increases in triglycerides have led to inflammation of the pancreas (pancreatitis) in some cases.

ESTIMATED RISK OF DEATH FROM A BIRTH-CONTROL METHOD OR PREGNANCY

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.

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 do not smoke should not take oral contraceptives is based on information from older high-dose pills. 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. Older women, as all women, who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with the individual patient needs.

WARNING SIGNALS

If any of these adverse effects occur while you are taking oral contraceptives, call your health-care provider 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 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).

SIDE EFFECTS OF ORAL CONTRACEPTIVES

1. Unscheduled or breakthrough vaginal bleeding or spotting

Unscheduled vaginal bleeding or spotting may occur while you are taking the pills. Unscheduled bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Unscheduled 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 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 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 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 healthcare provider.

GENERAL PRECAUTIONS

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. Stop taking oral contraceptives if you are pregnant.

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 should not be used during pregnancy. You should check with your health-care provider 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 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), primidone (Mysoline ®), topiramate (Topamax ®), carbamazepine (Tegretol ®is one brand of this drug), phenylbutazone (Butazolidin ®is one brand), some drugs used for HIV or AIDS such as ritonavir (Norvir ®), modafinil (Provigil ®) and possibly certain antibiotics (such as ampicillin and other penicillins, and tetracyclines), and herbal products containing St. John's Wort (Hypericum perforatum). You may also need to use a nonhormonal method of contraception during any cycle in which you take drugs that can make oral contraceptives less effective.

You may be at higher risk of a specific type of liver dysfunction if you take troleandomycin and oral contraceptives at the same time.

You should inform your health-care provider about all medicines you are taking, including nonprescription products.

5. Sexually transmitted diseases

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.

HOW TO TAKE LUTERA

IMPORTANT POINTS TO REMEMBER

BEFOREYOU START TAKING LUTERA:

• BE SURE TO READ THESE DIRECTIONS: Before you start taking LUTERA.

And

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. See " WHAT TO DO IF YOU MISS PILLS" below.

• 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 LUTERA. The problem will usually go away. If it doesn't go away, check with your health-care 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 (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINDES, including some antibiotics, your pills may not work as well.

Use a back-up nonhormonal method (such as condoms or spermicide) until you check with your health care provider.

• IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your health-care 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, contact your health-care provider.

BEFOREYOU START TAKING LUTERA

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 pill pack has 21 "active" white pills (with hormones) to take for 3 weeks, followed by 1 week of reminder peach pills (without hormones).
3. FIND:
   • where on the pack to start taking pills, and
   • in what order to take the pills (follow the arrow).
     

4. BE SURE YOU HAVE READY AT ALL TIMES:
   ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up in case you miss pills.
   AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRSTPACK OF PILLS

You have a choice of which day to start taking your first pack of pills.

Decide with your health-care 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. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the tablet dispenser.

Note: if the first day of your period is a Sunday, you can skip step #1.

• 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 nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

SUNDAY START

1. 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.
2. Use a nonhormonal method of birth control(such as condoms or spermicide) as a backup method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

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:
   Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS

If your previous brand had 21 pills:Wait 7 days to start taking LUTERA. You will probably have your period during that week. Be sure that no more than 7 days pass between the 21-day pack and taking the first white LUTERA pill ("active" with hormone).

If your previous brand had 28 pills:Start taking the first white LUTERA pill ("active" with hormone) on the day after your last reminder pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

LUTERA may not be as effective if you miss white "active" pills, and particularly if you miss the first few or the last few white "active" pills in a pack.

If you MISS 1white "active" pill:

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 COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2white "active" pills in a row in WEEK 1 OR WEEK 2of 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 COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2white "active" pills in a row in THE 3 rdWEEK:

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 that is expected.
   However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
3. You COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 3 OR MOREwhite "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 that is expected.
   However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
3. You COULD BECOME PREGNANT if you have sex in the 7 daysafter you restart your pills.
   You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you forget any of the 7 peach "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 nonhormonal birth-control method if you start your next pack on time.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your health-care provider.

BIRTH CONTROL AFTER STOPPING THE PILL

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your health-care provider.

PREGNANCY DUE TO PILL FAILURE

The incidence of pill failure resulting in pregnancy is approximately 1 per year (1 pregnancy per 100 women per year of use) if taken every day as directed, but the more typical failure rate is approximately 5% per year (5 pregnancies per 100 women per year of use) including women who do not always take the pill exactly as directed without missing any pills. If you do become pregnant, the risk to the fetus is minimal, but you should stop taking your pills and discuss the pregnancy with your health-care provider.

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 soon after stopping the pill.

BIRTH CONTROL AFTER STOPPING THE PILL

If you do not wish to become pregnant after stopping the pill, you should use another method of birth control immediately after stopping LUTERA. Speak to your health-care provider about another method of birth control.

OVERDOSAGE

Overdosage may cause nausea, vomiting, breast tenderness, dizziness, abdominal pain and fatigue/drowsiness. Withdrawal bleeding may occur 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 your 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 healthcare 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 healthcare 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.

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.
• 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 health-care provider or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read.

Manufactured by:
Patheon, Inc.
Mississauga, Ontario L5N 7K9 Canada

Distributed by:
Dr. Reddy’s Laboratories Inc.
Princeton, NJ 08540

Revised: 04/2024
Product of Canada

NDC 75907-079-55

Lutera ®

Levonorgestrel and Ethinyl Estradiol
Tablets USP

28-DAY REGIMEN

Each white tablet (21) contains 0.1 mg levonorgestrel and 0.02 mg ethinyl
estradiol. Each peach tablet (7) contains inert ingredients.

Rx Only

5 Blister Cards, 28 Tablets Each

Dr. Reddy's