Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
You should not use Norinyl 1+50, which contains higher doses of estrogen than other oral contraceptives, unless specifically recommended by your health care provider.
Any woman who considers using oral contraceptives ("birth control pills" 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 also will 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 regular visits. You also should follow the advice of your health care provider with regard to regular checkups while you are on the pill.
Oral contraceptives are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use). 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 are as follows:
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 also should 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 a safer method of birth control.
Tell your health care provider if you have or have had:
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.
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 from the table that for women aged 15 to 39 the risk of death is 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 4 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, 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.
BEFORE
Brevicon (Norethindrone) , Norinyl 1+35, Norinyl 1+50
Active Pill Colors: White or Yellow-Green or Blue
Reminder Pill Color: Orange
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:
SUNDAY START:
If you white or yellow-green or blue "active" pill:
If you white or yellow-green or blue "active" pills in a row in of your pack:
If you white or yellow-green or blue "active" pills in a row in
If you white or yellow-green or blue "active" pills in a row (during the first 3 weeks):
FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:
Use a BACK-UP METHOD anytime you have sex.
KEEP TAKING ONE "ACTIVE" PILL EACH DAY until you can reach your doctor or clinic.
6. Missed periods, spotting or light bleeding
At times, you may not have a period after you have completed a pack of pills. If you miss 1 period but you 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 have missed a period, you may be pregnant and you should stop taking the Pill until your doctor or clinic determines whether or not you are pregnant. Until you can talk to your doctor or clinic, use an appropriate back-up birth control method. If you miss 2 consecutive periods, you should stop taking the Pill until it is determined that you are not pregnant.
Even if spotting or light bleeding should occur, continue taking the Pill according to the schedule. Should spotting or light bleeding persist, you should notify your doctor or clinic.
7. Stopping the pill before surgery or prolonged bed rest
If you are scheduled for surgery or you need to stay in bed for a long period of time you should tell your doctor that you are on the Pill. You should stop taking the Pill four weeks before your operation to avoid an increased risk of blood clots. Talk to your doctor about when you may start taking the Pill again.
8. Starting the pill after pregnancy
After you have a baby it is advisable to wait 4-6 weeks before starting to take the Pill. Talk to your doctor about when you may start taking the Pill after pregnancy.
9. Pregnancy due to pill failure
When the Pill is taken correctly, the expected pregnancy rate is approximately 1% (i.e., 1 pregnancy per 100 women per year). If pregnancy occurs while taking the Pill, there is little risk to the fetus. The typical failure rate of large numbers of pill users is less than 3% when women who have missed pills are included. If you become pregnant, you should discuss your pregnancy with your doctor.
10. Pregnancy after stopping the pill
There may be some delay in becoming pregnant after you stop taking the Pill, especially if you had irregular periods before you started using the Pill. Your doctor may recommend that you delay becoming pregnant until you have had one or more regular periods.
There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the Pill.
11. Overdosage
There are no reports of serious illness or side effects in young children who have swallowed a large number of pills. In adults, overdosage may cause nausea and/or bleeding in females. In case of overdosage, contact your doctor, clinic or pharmacist.
12. Other information
Your doctor or clinic will take a medical and family history and will examine you before prescribing the Pill. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your doctor or clinic if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your doctor or clinic because this is a time to determine if there are early signs of side effects from using the Pill.
Do not use the Pill for any condition other than the one for which it was prescribed. The Pill has been prescribed specifically for you, do not give it to others who may want birth control pills.
If you want more information about birth control pills, ask your doctor or clinic. They have a more technical leaflet called which you might want to read.
In addition to preventing pregnancy, use of oral contraceptives may provide certain non-contraceptive health benefits:
Store at controlled room temperature 15-25˚C (59-77˚F).
Keep this and all medication out of the reach of children.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 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 oral contraceptives 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:
You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first 3 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:
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 anti-convulsants and some antibiotics, may decrease oral contraceptive effectiveness.
Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use.
Taking the pill provides some important non-contraceptive health 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 a good medical practice to postpone it. You should be re-examined 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.
See full text of HOW TO TAKE THE PILL which is printed in full in the Detailed Patient Labeling.
Manufactured by: Patheon, Inc.Mississauga, Ontario L5N 7K9CANADA
Rev: June 2006IN-5313/S
