Consumer Information for: ZAMINE 28

ZAMINE is a birth control pill containing estrogen and progestogen. The progestogen in ZAMINE is known as drospirenone and it may increase potassium. Therefore, you should not take ZAMINE if you have kidney, liver, or adrenal disease (a disease that may alter the body’s fluid and mineral balance) because this could cause serious heart and health problems. Other drugs may also increase potassium (see Before you use ZAMINE, talk to your doctor or pharmacist if you). During the first month that you take ZAMINE, you should have a blood test to check your potassium level.

It has been reported that drospirenone, the progestogen in ZAMINE, may carry a higher risk of blood clots than some other progestogens (including levonorgestrel). You should talk to your doctor about the available options.

BEFORE you use ZAMINE, talk to your doctor or pharmacist if you:

• smoke
• are overweight
• have a history of breast disease (eg, breast lumps) or a family history of breast cancer
• have high blood pressure
• have high cholesterol
• have diabetes
• have heart or kidney disease
• have a history of seizures/epilepsy
• have a history of depression
• have a history of liver disease or jaundice
• wear contact lenses
• have uterine fibroids (benign tumours of the uterus)
• may be pregnant or are breast feeding
• have systemic lupus erythematosus
• have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• have hemolytic uremic syndrome
• have sickle cell disease
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages
• you are currently on daily, long-term treatment for a chronic condition with any of the medications listed below:
• Nonsteroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (eg, ibuprofen, naproxen or others)
• Potassium-sparing diuretics (spironolactone and others
• Potassium supplements
• ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (eg, captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others)
• Heparin

You should also inform your doctor about a family history of blood clots, heart attacks, or strokes.

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

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. You should consult your doctor about stopping the use of ZAMINE four weeks before surgery and not using ZAMINE for a time period after surgery or during bed rest.

ZAMINE 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 ZAMINE 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 ZAMINE outweigh the risks, you should be aware of the following:

THE RISKS OF USING ZAMINE

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 blood clots is especially high during the first year a woman ever uses a hormonal contraceptive or restarts the same or a different hormonal contraceptive. Clots can occur in many parts 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 which may increase with deep breathing; coughing blood; sudden shortness of breath or rapid breathing; sense of anxiety; severe light headedness or dizziness; rapid or irregular heartbeat. These symptoms could indicate a possible blood clot in the lung.
• pain and/or swelling in the calf or along a vein in the leg; pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg; red or discoloured skin on the leg. These symptoms could indicate a possible blood clot in the leg.
• crushing chest pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats. These symptoms could indicate a possible heart attack.
• sudden severe or worsening headache or vomiting; sudden trouble walking, dizziness, loss of balance or coordination; loss of consciousness or fainting with or without seizure; sudden confusion, disturbances of vision, speech or understanding; sudden weakness or numbness of the face, 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.
• other signs of a blood clot can include: sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen;

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.

Cancer of the breast, cervix, or liver may be life-threatening or may result in death

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 hormonal contraceptives 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 health care professional is recommended for all women.

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

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.

The short and long-term use of birth control pills also has been linked with the growth of liver tumours. Such tumours are EXTREMELY rare.

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

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.

Birth control pills should not be taken by pregnant women. 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.

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

You will have a menstrual period when you stop using ZAMINE. 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.

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. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.