Diane-35

Drug name: Diane-35

Other names used:

• Dianette®

Active Ingredients: cyproterone, ethinyl estradiol.

Therapeutic actions: The substance cyproterone acetate contained in Diane-35 blocks the effect of endogenously produced and exogenously administered androgens at the target organs by means of competitive inhibition. Apart from the described anti-androgen effect, cyproterone acetate also has a progestational action. The ethinylestradiol in the combination inhibits ovulation and changes the cervical mucus and the endometrium rendering them unfavourable for sperm penetration and nidation of a fertilised ovum, respectively.

Indications: This medicine is an estrogen and progestin combination used to prevent pregnancy. It may also be used to regulate the menstrual cycle, treat symptoms of menopause, or treat other conditions as determined by your doctor. You must take the medecine the same time every day, not more than 24 hours apart.

Contraindications and cautions: You should tell your doctor if: you smoke, you have diabetes, you are overweight, you have high blood pressure, you have a heart valve disorder or a certain heart rhythm disorder, you have an inflammation of your veins (superficial phlebitis), you have varicose veins or anyone in your immediate family has had thrombosis, a heart attack or a stroke. If you suffer from hirsutism and it has only recently appeared or has lately intensified to a considerable extent the doctor must be informed of this. DIANE-35 does not protect against HIV infection (AIDS) or any other sexually transmitted disease. DIANE-35 is not for use in men.

Adverse effects: The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. You must not use DIANE-35 if: you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke), Diabetes mellitus with blood vessel damage you have jaundice (yellowing of the skin) or severe liver disease you have or have had cancer of the breast or the genital organs, if you have or have had a benign or malignant liver tumour, if you have any unexplained vaginal bleeding you are pregnant or think you might be pregnant or if you are breast-feeding, if you are allergic to any of the ingredients of DIANE-35. If any of these conditions appear for the first time while using DIANE-35, stop taking it at once and consult your doctor.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

Interactions: Tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine.

Some oral medicines may stop DIANE-35 from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor who prescribes DIANE-35 which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use DIANE-35. They can tell you if you need to take additional contraceptive precautions and if so, for how long. DIANE-35 and breastfeeding DIANE-35 must not be used during breastfeeding. DIANE-35 and pregnancy DIANE-35 must not be used by women who are pregnant, or who think they may be pregnant.

Additional Information: DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.