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Ortho-Novum Patient, Information, Instructions - Norethindrone and Ethinyl Estradiol

Ortho-Novum Patient, Information, Instructions - Norethindrone and Ethinyl Estradiol

PATIENT INFORMATION

PATIENT PACKAGE INSERT

BRIEF SUMMARY

This product (like all other 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 3% 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:

Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with 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.

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.


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, vomiting and breakthrough bleeding, 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:

1. Blood clots in the legs (thrombophlebitis), 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.

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 professional 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.

Most of the studies to date on breast cancer and pill use have found no increase in the risk of developing breast cancer although some studies have reported an increased risk of developing cancer in certain groups of women. However, some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill. Therefore, there is insufficient evidence to rule out the possibility that the pill may cause cancer of the breast or cervix.

Taking the combination 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 health care provider. Your health care provider will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and your health care 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 labeling gives you further information which you should read and discuss with your health care provider.

DETAILED PATIENT LABELING

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.

What You Should Know About Oral Contraceptives: 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 patient labeling 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 labeling is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this labeling with him or her, both when you first start taking the pill and during your revisits. You should also follow your doctor's or clinic'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 other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

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

Who Should Not Take Oral Contraceptives

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.


Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions:

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 doctor or clinic if you have:

Women with any of these conditions should be checked often by their doctor or clinic if they choose to use oral contraceptives.

Also, be sure to inform your doctor or clinic if you smoke or are on any medications.

Risks of Taking Oral Contraceptives

Risk of Developing Blood Clots: Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptive; in particular, a clot in the leg 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 or clinic 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. It is advisable to wait for at least four weeks after delivery if you are not breast feeding or four weeks after a second trimester abortion. If you are breast feeding, you should wait until you have weaned your child before using the pill. (See also General Precautions, While Breast Feeding.)

The risk of circulatory disease in oral contraceptive users may be higher in users of high dose pills and may be greater with longer duration of oral contraceptive use. In addition, some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages. For women aged 20 to 44 it is estimated that about 1 in 2000 using oral contraceptives will be hospitalized each year because of abnormal clotting. Among non-sers in the same age group, about 1 in 20,000 would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34 the risk of death due to a circulatory disorder is about 1 in 12,000 per year, whereas for non-users the rate is about 1 in 50,000 per year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500 per year for oral contraceptive users and about 1 in 10,000 per year for non-users.

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 the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.

Gallbladder Disease: Oral contraceptive users probably have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens.

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, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.

Cancer of the Reproductive Organs and Breasts: There is, at present, no confirmed evidence that oral contraceptive use increases the risk of deleopling cancer of the reproductive organs. Studies to date of women taking the pill have reported conflicting findings on whether pill use increases the risk of develloping cancer of the breast or cervix. Most of the studies on breast cancer and pill use have found no overall increase in the risk of developing breast cancer although some studies have reported an increased risk of developing breast cancer in certain groups of women. Women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be closelt follwed by their doctors.

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.

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 TABLE 2.

In TABLE 2, 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 (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40, 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 higher-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 low-dose oral contraceptive use by healthy, non-smoking 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.

Warning Signals: If any of these adverse effects occur while you are taking oral contraceptives, call your doctor or clinic immediately:

Side Effects of Oral Contraceptives

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 wflow 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 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 clinic.

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 change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.

If any of these side effects bother you, call your doctor or health care provider.

General Precautions

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 doctor or health care provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period or if you have 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 or clinic about risks to your unborn child of any medication taken during pregnancy.

While Breast Feeding: If you are breast feeding, consult your doctor or clinic 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.

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.

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), phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand), and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective.

INSTRUCTIONS TO THE PATIENT

These are general instructions. Package configuartions and pill colors vary from product to product.

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 The Pill-Important Points to Remember

Before You Start Taking Your Pills:

1. Be Sure to Read These Directions: Before you start taking your pills. Anytime you are not sure what to do.

2. The Right Way to Take the Pill is to Take One Pill Every Day at the Same Time: If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.

3. Many Women Have Spotting or Light Bleeding, or May Feel Sick to Their Stomach During the First 1-3 Packs of Pills: If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic.

4. Missing pills can also cause spotting or light bleeding , even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

5. If you have vomiting or diarrhea, for any reason, or if you take some medicines, including some antibiotics, your pills may not work as well. Use a 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 about the same time every day.

2. Look at Your Pill Pack to See if it Has 21 or 28 Pills:

The 21-pill pack has 21 "active" pills (with hormones) to take for 3 weeks, followed by 1 week without pills.

The 28-pill pack has 21 "active" pills (with hormones) to take for 3 weeks, followed by 1 week of reminder pills (without hormones).

3. Also Find:

A) Where on the pack to start taking pills,

B) In what order to take the pills (follow the arrows) and

C) The week numbers printed on the pack.

4. Be Sure You Have Ready at All Times:

Another kind of birth control (such as condoms or foam) 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 may 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. 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).

2. Place this day label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted in the plastic. Note: If the first day of your period is a Sunday, you can skip steps #1 AND #2. Note: If the first day of your period is a Sunday, you can skip steps and #2.

3. Take the first "active" [white] pill of the first pack during the first 24 hours of your period.

4. 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" 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 or foam 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:

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 "reminder" pill. Do not wait any days between packs.

What to do if You Miss Pills:

If you MISS 1 "active" pill:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you take 2 pills in 1 day.

2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 "active" pills in a row in WEEK I OR WEEK 2 of your pack:

1. Take 2 pills on the day you remember and 2 pills the next day.

2. Then take 1 pill a day until you finish the pack.

3. You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken an "active" pill every day for 7 days.

If you MISS 2 "active" pills in a row in the 3RD WEEK:

1a. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

1b. 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 COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken an "active" pill every day for 7 days.

If you MISS 3 OR MORE "active" pills in a row (during the first 3 weeks).

1a. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

1b. 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 COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken an "active" pill every day for 7 days.

A Reminder For Those On 28-Day Packs:

If you Forget any of the 7 "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.

Finally, if You are Still Not Sure What to do About the Pills You Have Missed:

Pregnancy Due to Pill Failure: The incidence of pill failure resulting in a pregnancy is approximately 1% (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. If failure does occur, the risk to the fetus is minimal.

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.

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 doctor or clinic will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and your health care provider believes it is a good medical practice 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.

Health Benefits From Oral Contraceptives

In addition to preventing pregnancy, use of combination oral contraceptives may provide certain benefits. They are:

If you want more information about birth control pills, ask your doctor, clinic or pharmacist. They have a more technical leaflet called the "Professional Labeling", which you may wish to read.

Remembering to take tablets according to schedule is stressed because of its importance in providing you the greatest degree of protection.

Missed Menstrual Periods for Both Dosage Regimens

At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly and miss a menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor or health care provider determines whether or not you are pregnant. Until you can get to your doctor, use another method of contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined whether or not you are pregnant. Although there does not appear to be any increase in birth deffects in newborn babies, if you become pregnant while using oral contraceptives, you should discuss the situation with your doctor or health care provider.

Periodic Examination: Your doctor or health care provider will take a complete medical and family history before prescribing oral contraceptives. At that time and about once a year thereafter, he or she will generally examine your blood pressure, breasts, abdomen, and pelvic organs (including a Papanicolanou smear [i.e., test for cancer]).

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