Diane 35 (Cyproterone/Ethinyl Estradiol)

Do not take cyproterone - ethinyl estradiol if you:

• are allergic to cyproterone, estradiol, or any ingredients of the medication
• are or may be pregnant
• have a history of cholestatic jaundice (yellowing of the skin, whites of the eyes caused by problems with bile flow)
• have active liver disease
• have any eye problems caused by blood vessel disease in the eye (such as partial or complete loss of vision or other vision changes)
• have existing or have had blood vessel or blood clotting disorders (including deep vein thrombosis, pulmonary embolism, thrombophlebitis, cerebrovascular disease such as stroke, heart attack, and coronary artery disease)
• have had otosclerosis (abnormal bone growth in the ear) that worsened during pregnancy
• have known or suspected breast cancer
• have known or suspected tumours dependent on estrogen
• have or have had liver tumours
• have severe diabetes with blood vessel changes
• have undiagnosed abnormal vaginal bleeding
• are taking another estrogen/progestogen combination or estrogens or prosetogens alone
• have a hereditary condition called angioedema (a condition which causes swelling of the hands, feet, face, or airways)

There may be an interaction between cyproterone - ethinyl estradiol and any of the following:

This medication is taken in 28-day cycles consisting of 1 tablet daily for 21 days, followed by a 7-day interval without medication (i.e., 3 weeks on, 1 week off). Tablets should be taken at the same time each day. Treatment is usually started on the first day of menstrual bleeding. Often, several months of treatment are needed before improvement is seen. Once the acne has completely resolved, this medication is usually continued for another 3 or 4 cycles and then stopped. This medication may be restarted if your acne returns.

If spotting or breakthrough bleeding occurs during the 3 weeks during which this medication is being taken, continue taking this medication. The spotting or breakthrough bleeding is usually temporary. If bleeding is persistent or lasts a long time, contact your doctor.

If your menstrual period fails to occur during the 7-day tablet-free interval, do not start the next medication cycle and contact your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. The medication will be less effective if you miss doses. If you miss a dose of this medication, and you remember within 12 hours, take the missed dose. If more than 12 hours have passed, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time. An additional non-hormonal method of birth control (e.g., condoms) should be used until the pack is empty. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• breast pain, tenderness, or swelling
• brown, blotchy spots on exposed skin
• dizziness
• headache
• increased or decreased interest in sexual intercourse
• nausea
• swelling of ankles and feet
• unusual tiredness or weakness
• vomiting
• weight gain or loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• changes in the uterine bleeding pattern during or between menstrual periods (such as decreased bleeding, breakthrough bleeding or spotting between periods, prolonged bleeding, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• for women with diabetes: mild increase of blood sugar, faintness, nausea, pale skin, or sweating
• for women with a history of breast disease: lumps in breast
• headaches or migraines (although headaches may lessen for many users, they may increase in number or become worse for others)
• increased blood pressure
• symptoms of liver problems (e.g., swelling, pain, or tenderness or lump in upper abdominal area, yellowing of eyes or skin, skin itching)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abdominal or stomach pain (sudden, severe, or continuing)
• signs of blood clots (e.g., coughing up blood; pains in chest, groin, or leg – especially in calf of leg)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• shortness of breath
• swelling of the face, hands, feet, or airways

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.