Consumer Information for: TEVA-CYPROTERONE / ETHINYL ESTRADIOL

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-CYPROTERONE / ETHINYL ESTRADIOL. Talk about any health conditions or problems you may have, including if you:

• smoke
• smoke more than 15 cigarettes a day and are over age 35. Your doctor may decide on a different treatment for you
• are overweight
• have a history of breast disease (eg, breast lumps) or a family history of breast cancer
• have an immediate family member who has ever had a blood clot (in the leg, lung or other parts of the body), a heart attack or a stroke at a young age
• have high blood pressure, or a family history of it
• have high cholesterol or if someone in your immediate family has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• have diabetes, or a family history of it
• suffer from migraines (headaches with symptoms such as disturbed vision or nausea)
• have heart or kidney disease
• have a history of liver disease
• have a history of jaundice (yellowing of the skin or eyes), especially if this happened during pregnancy
• have a history of seizures/epilepsy
• asthma or difficulty breathing
• fluid retention (such as swelling of lower legs)
• have a history of depression (sad mood that won’t go away)
• wear contact lenses. If you wear contact lenses and develop visual changes or changes in lens tolerance, you should see an ophthalmologist. Temporary or permanent discontinuation of contact lens use should be considered
• are near-sighted or have astigmatism. Estrogen/progestogen combinations can make these problems worse, especially in women who have a family history of myopia
• have uterine fibroids (non-cancerous growths of the uterus)
• have systemic lupus erythematosus, a disease where the immune system injures the body's own organs and tissues. In some women, the use of estrogen/progestogen combinations may lead to worsening of joint and muscle pain
• have an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• may be pregnant or are breastfeeding
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• have golden brown pigment patches sometimes called ‘pregnancy patches’ especially on the face (chloasma). If this is the case, avoid direct exposure to sunlight or ultraviolet light
• have polycystic ovary syndrome (a disorder where many small cysts grow on the ovary and may cause irregular menstrual periods, infertility, acne or excess hair growth. This disorder may increase the risk of blood clots)
• 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
• menstrual periods that are light or that occur in an irregular pattern
• have a scheduled lab test or surgery. Consult your doctor about stopping TEVA-CYPROTERONE / ETHINYL ESTRADIOL. It should be stopped for four weeks before surgery. After surgery, wait until you have a full menstrual period before re-starting TEVA-CYPROTERONE / ETHINYL ESTRADIOL

Other warnings you should know about:

You should not take TEVA-CYPROTERONE / ETHINYL ESTRADIOL for the purpose of birth control alone. If you take it as directed, it will provide reliable birth control. You should not use other hormonal birth control methods when on TEVA-CYPROTERONE / ETHINYL ESTRADIOL. If you miss a dose of TEVA-CYPROTERONE / ETHINYL ESTRADIOL, use a non-hormonal birth control to prevent pregnancy.

Do NOT take TEVA-CYPROTERONE / ETHINYL ESTRADIOL if you are obese and have high blood pressure, and diabetes. This combination is particularly hazardous. Your doctor should prescribe a different acne treatment for you.

TEVA-CYPROTERONE / ETHINYL ESTRADIOL should only be used in women older than 35 in exceptional cases. You and your doctor must decide that the benefits are greater than the risks. You should know that the risk of serious side effects goes up after age 35. You will need to use TEVA-CYPROTERONE / ETHINYL ESTRADIOL for a shorter amount of time. You should be seen regularly by the doctor. In addition, you should not smoke.

Breast Cancer

Cancer of the breast may be life-threatening or may result in death.

The risk of breast cancer goes up with:

• increasing age
• strong family history of breast cancer (mother or sister)
• obesity
• never having children
• having your first full-term pregnancy at a late age
• use of drugs that contain estrogen/progestogen combinations such as TEVA-CYPROTERONE / ETHINYL ESTRADIOL for more than 8 years
• using estrogen/progestogen combination drugs at an early age

The risk of breast tumors gradually goes down after stopping the combined pills.

A yearly breast examination by a healthcare professional is recommended. Talk to your doctor about breast self-examination. Tell your doctor right away if you find a new lump or mass.

Liver Cancer

Cancer of the liver may be life-threatening or may result in death.

Tumors caused by cancer and other reasons can occur. These have led to life-threatening internal bleeding. Contact your doctor immediately if you have severe pain or a lump in your abdomen.

Pregnancy

You should NOT use TEVA-CYPROTERONE / ETHINYL ESTRADIOL if you are pregnant or think that you may be pregnant. It will not prevent the pregnancy from continuing. It may interfere with the normal development of your baby. If you become pregnant while taking TEVA-CYPROTERONE / ETHINYL ESTRADIOL, stop taking it immediately and contact your doctor.

Use after pregnancy, miscarriage or an abortion

Talk to your doctor before using TEVA-CYPROTERONE / ETHINYL ESTRADIOL after childbirth, miscarriage, or having an abortion.

Pregnancy after stopping TEVA-CYPROTERONE / ETHINYL ESTRADIOL

If you wish to become pregnant, talk with your doctor. They may recommend that you stop using TEVA-CYPROTERONE / ETHINYL ESTRADIOL and delay pregnancy until you have at least one period (menstrual cycle). Contact your doctor for advice and on methods of birth control that may be used during this time.

Tell all healthcare professionals about all the medicines you take. This includes TEVA-CYPROTERONE / ETHINYL ESTRADIOL and any other drugs, vitamins, minerals, natural supplements or alternative medicines.

Certain drugs may interact with TEVA-CYPROTERONE / ETHINYL ESTRADIOL. They can make it less able to prevent pregnancy. Or, they can cause unexpected vaginal bleeding. Healthcare professionals can tell you if you need to use an additional method of birth control while using another medicine and if so, for how long.