Details for: AVIANE

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.

BEFORE you use AVIANE talk to your doctor or pharmacist if the following apply to you:

• Breast conditions
• A strong family history of breast cancer
• Breast disorders including pain, discharge from the nipples, thickenings, or lumps. In some circumstances, benefit may be derived from taking the pill; in other cases, adverse effects may follow.
• Diabetes
• High blood pressure
• Abnormal levels of fats in the bloodstream (high cholesterol or triglycerides)
• Cigarette Smoking
• Heart or kidney disease
• Epilepsy/seizures
• History of Depression
• Fibroid tumours of the uterus
• Gallbladder or pancreatic disease
• History of liver disease or jaundice
• Family history of blood clots, heart attacks or strokes.
• May be pregnant or breast feeding
• Have systemic lupus erythmatosus
• Have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• Have haemolytic uremic syndrome
• Have sickle cell disease
• Have problems with the valves in your heart and/or have irregular heart rhythm
• Wear contact lenses
• Have Hepatitis C

If you see a different doctor, inform him or her that you are using AVIANE.

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

Also tell your doctor if you are scheduled for MAJOR surgery, recent delivery, or second-trimester abortion. You should consult your doctor about stopping the use of AVIANE four weeks before major surgery and not using AVIANE for a time period after surgery or during prolonged bed rest.

AVIANE 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 AVIANE 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. If you and your doctor decide that, for you, the benefits of AVIANE outweigh the risks, you should be aware of the following:

THE RISKS OF USING BIRTH CONTROL PILLS

1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes or brain)

Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing clots is especially high during the first year a woman ever uses a hormonal contraceptive. Clots can occur in many areas of the body.

Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:

• Sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung;
• Pain and/or swelling in the calf. These symptoms could indicate a possible clot in the leg;
• Crushing chest pain or heaviness. These symptoms could indicate a possible heart attack;
• Sudden severe or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke;
• Sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.

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 or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.

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 strong 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.

ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION 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.

Chronic infection with the Human Papilloma Virus (HPV) is believed to be the most important risk factor for cervical cancer. In women who use COCs for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the Pill itself but may be related to sexual behaviour and other factors.

4. Liver tumours

The short and long-term use of birth control pills have also been linked with the growth of liver tumours or liver injury (e.g., hepatitis, hepatic function abnormal). Such injury or tumours are extremely rare.

Contact your doctor immediately if you experience nausea, vomiting, severe pain or a lump in the abdomen.

5. Gallbladder disease

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.

6. Use in pregnancy

Birth control pills should not be taken by pregnant women. They will not prevent the pregnancy from continuing. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.

7. Use after pregnancy, miscarriage or an abortion

Your doctor will advise you of the appropriate time to start the use of AVIANE after childbirth, miscarriage, or therapeutic abortion.

8. Pregnancy after stopping AVIANE

You will have a menstrual period when you stop using AVIANE. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.

9. Use while breast-feeding

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. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception. The use of oral contraceptives is generally not recommended until the nursing mother has completely weaned her child.