Cyproterone and Ethinyl Estradiol Overview

(sye PROE ter one & ETH in il es tra DYE ole)

Cyestra-35; Diane-35®; Novo-Cyproterone/Ethinyl Estradiol

Diane; Eunice-35

Acne Products; Estrogen and Progestin Combination

• If you have an allergy to cyproterone, ethinyl estradiol, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have any of the following conditions: Blood clots, breast cancer, diseased arteries in the brain, disease of a heart valve with complications, endometrial cancer, heart disease, high blood pressure, liver disease, liver tumor, severe headache, tumor where estrogen makes it grow, or unexplained vaginal bleeding.

• If you have major surgery and need bedrest.

• If you are a heavy smoker (more than 15 cigarettes per day) and older than 35 years of age.

• If you have not started menstruating.

• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.

• If you are pregnant or may be pregnant.

• This medicine may decrease free testosterone levels.

• Follow directions given by healthcare provider or read the package insert.

• Take this medicine at a similar time of day.

• Take a missed dose as soon as possible and return to your regular schedule.

• Missed dosing information can be found in the package insert or call healthcare provider for instructions.

• Change in condition being treated. Is it better, worse, or about the same?

• If you are taking a blood thinner, check blood work (prothrombin time/INR). Talk with healthcare provider.

• Check blood pressure and heart rate regularly. Talk with healthcare provider.

• If you are diabetic, you will need to monitor blood sugars closely.

• Check blood work (cholesterol panel). Talk with healthcare provider.

• Have a yearly eye exam.

• Periodic breast (monthly self-exam) and yearly gynecologic exams are important.

• If you miss two menstrual periods in a row, take a pregnancy test before starting a new dosing cycle.

• Follow up with healthcare provider yearly.

• Store at room temperature.

• Protect from moisture. Do not store in a bathroom or kitchen.

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Read the package insert for more details.

Created: 2007-06-05 08:27:04.0

Modified: 2010-03-25 09:11:23.0

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