Consumer Information for: SELECT 1/35 (21-DAY)

There are also conditions that your doctor will want to watch closely or that might cause your doctor to recommend a method of contraception other than birth control pills.

If you see a different doctor, inform him or her that you are taking SELECT 1/35.

BEFORE you use SELECT 1/35 talk to your doctor or pharmacist if:

• Pregnant or breastfeeding
• History of jaundice or other liver disease
• High blood pressure
• Migraines and headaches
• Diabetes or family history of diabetes
• Wear contact lenses
• Family history of breast disease (e.g. breast lumps) or a family history of breast cancer
• Fibroid tumours on the uterus
• History of emotional disorders, especially depression
• Metabolic or endocrine diseases and abnormal metabolism of calcium and phosphorus
• Rheumatoid arthritis or synovitis
• Hereditary or history of angioedema (episodes of swelling in body parts such as hands, feet, face, or airway passage)
• Abnormal level of fat in the blood stream (high cholesterol or triglycerides)
• Smoke cigarettes
• Heart or kidney disease
• Epilepsy
• Gallbladder or pancreatic disease
• Family history of blood clots, heart attacks or strokes.
• Persistent irregular vaginal bleeding
• Overweight
• Systemic lupus erythematosus
• Inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• Hemolytic uremic syndrome
• Sickle cell disease
• Problems with the valves in your heart and/or have an irregular heart rhythm
• Have Hepatitis C

If you detect any new masses on your breasts while taking SELECT 1/35 you should advise your doctor.

If you have to undergo a major elective surgery, you should advise your surgeon that you are taking SELECT 1/35. You should consult your doctor about stopping the use of SELECT 1/35 four weeks before surgery and not use SELECT 1/35 for a time period after surgery or during bed rest.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

SELECT 1/35 should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use SELECT 1/35 only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant.

Breakthrough bleeding/spotting may occur while you are taking an oral contraceptive, especially during the first three months of use. If this bleeding persists or recurs, you should advise your doctor. Women with history of amenorrhea (absence of menstrual periods) or oligomenorrhea (irregular or infrequent menstrual periods) may remain anovulatory or become amenorrheic following discontinuation of oral contraceptives.

The Risks of Using Birth Control Pills

1. Circulatory disorders (including blood clots in legs, lungs, heart, eyes or brain)
   Blood clots are the most common serious side effect of birth control pills. Clots can occur in many areas of the body.
   
   
   • In the brain, a clot can result in a stroke.
   • In a blood vessel of the heart, a clot can result in a heart attack.
   • In the legs and pelvis, a clot can break off and travel to the lung resulting in a pulmonary embolus.
   • In a blood vessel leading to an arm or leg, a clot can result in damage to or loss of a limb.

   Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision.
   
   Women who use birth control pills have a higher incidence of blood clots. While the risk of blood clots increases with age in both pill users and non users, the increased risk from the pill appears to be present at all ages. The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.

2. Breast Cancer
   The most significant risk factors for breast cancer are increasing age and a history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.
   
   Some women who use birth control pills may be at increased risk of developing breast cancer before menopause which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small, however a yearly breast examination by a doctor is recommended for all women.
   
   Women with the following conditions should be examined yearly by their doctors no matter what method of contraception they use:
   • a history of breast cancer in the family
   • breast nodules or thickenings
   • discharge from the nipple

   ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELFEXAMINATION OF YOUR BREASTS.

3. Cervical cancer
   Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.


4. Dangers to developing child if birth control pills are used during pregnancy
   Oral contraceptives should not be taken by pregnant women because they may damage the developing child. An increased risk of heart and limb and other defects has been associated with the use of sex hormones, including oral contraceptives, during pregnancy. In addition, the developing female child whose mother has received DES (diethylstilbestrol), an estrogen, during pregnancy has a risk of developing cancer of the vagina or cervix in her teens or young adulthood. Abnormalities of the urinary tract and sex organs have been reported in male offspring so exposed. It is possible, although this has not been demonstrated, that other estrogens such as those in oral contraceptives could have the same effect in the child if the mother takes them during pregnancy.

   There is also no conclusive evidence that the use of birth control pills immediately before a pregnancy will adversely affect a baby's development. When a woman stops taking birth control pills to become pregnant, however, her doctor may recommend a different method of contraception until she has a period on her own. In this way, the pregnancy can be more accurately dated.

5. Gallbladder disease and liver tumours
   Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.

   The short and long-term use of birth control pills also has been linked with the growth of benign or malignant liver tumours. Such tumours are extremely rare. Benign tumours do not spread but they may rupture and produce internal bleeding which may cause death.

6. Use during pregnancy
   Birth control pills should never be taken if you think you are pregnant. They will not prevent the pregnancy from continuing and may interfere with the normal development of the baby.


7. Pregnancy after stopping taking birth control pills
   You will have a menstrual period when you stop taking birth control pills. You should delay pregnancy until another menstrual period occurs within four to six weeks. Contact your doctor for recommendations on alternate methods of contraception during this time.


8. Use after pregnancy, miscarriage or abortion
   Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.


9. Use while breastfeeding
   If you are breast feeding, consult your doctor before starting the birth control pill. The hormones in birth control pills are known to appear in breast milk. These hormones may decrease the flow of breast milk. The long-term effects on the developing child are not known. However, cases of breast enlargement have been reported in breast-fed infants. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.