The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Diane-35 Birth Control Pills
Active ingredient: cyproterone
Diane-35 contains two active ingredients - synthetic progestogen called cyproterone acetate and synthetic oestrogen - ethinyloestradiol.
Diane-35 is low-dose monophasic combined oral hormonal contraceptive with antiandrogenic effects (estrogen anti-androgenic medicine). Pharmacological properties of Diane-35 are determined by its two active ingredients - cyproterone acetate and ethinylestradiol. The medication possesses two main effects: contraceptive and anti-androgenic effect.
Antiandrogen effect of Diane-35 pills contraceptive.
Cyproterone acetate possesses the ability to bind to the receptors of the natural male sex hormones - androgens which are produced not only in the male sex glands, but in small amounts in women, mainly in the adrenal glands, ovaries and skin . Cyproterone reduces the effects of androgens produced in the female body, allowing treating diseases caused by excessive formation of androgens or an increased susceptibility to them. Derivatives of the skin such as sebaceous glands and hair follicles are androgen-dependent entities respond to increased levels of androgen production by increasing of sebum production. Sebum is a pathogenic factor in the development of seborrhea and acne (blackheads) and excessive hair growth in women all over the body or its separate parts for male pattern (hirsutism), while loss of hair (androgenic alopecia). Cyproterone blocks the androgen receptors in target organs, thus, reduces the effects of androgens. The therapeutic effect of Diane-35 is manifested in the healing of acne, preventing the formation of new acne forms, reducing excessive sebaceous excretions on the scalp of catches and the skin. In most cases, Diane-35 helps eliminate acne within 3-4 months. Reduction of hirsutism symptoms can be expected only in a few months after starting treatment with DIANE-35.
Contraceptive action of DIANE-35:
Diane-35 birth control medicine provides several ways to prevent pregnancy, the most important of which is ovulation inhibition and change the viscosity of cervical mucus. Along with ant androgenic properties, cyproterone has progestogenic activity. Cyproterone works by inhibiting the secretion of pituitary gonadotropin-releasing hormone and inhibits ovulation, causing a contraceptive effect. At the same time Ethinylestradiol enhances central and peripheral effect of cyproterone on ovulation, retains a high viscosity of cervical mucus, making it difficult penetration of sperm cells into the uterus. Diane-35 guarantees almost 100% protections from undesirable pregnancy. As with all combined oral contraceptives, Diane-35 has a positive effect on the non-contraceptive health. Menstruation becomes easier and shorter, which reduces the risk of iron deficiency anemia, pain in dysmenorrhea become less pronounced or disappear entirely.
Diane-35 is used to treat androgen-dependent and hyperandrogenic disorders in women:
- Acne (acne vulgaris), especially in their expressed form, accompanied by seborrhea, inflammatory phenomena to the formation of nodes
- Androgenetic alopecia (hair loss);
- Hirsutism - hair growth in male pattern (light form);
- Oral contraception in women with symptoms of androgenization.
Diane-35 Dosage and Administration
Diane-35 ED should be taken regularly in order to achieve therapeutic efficacy and the needed contraceptive protection. Previously used hormonal oral birth control pills should be discontinued. The dose regimen of Diane-35 is similar to other birth control medicine. The irregular use of Diane-35 may result in intermenstrual bleeding and could decrees the therapeutic and birth control effects.
One tablet of Diane-35 should to be taken daily. The tablets must be taken in the order directed on the pack at about the same time every day, with some liquid as needed. You should take tablets for 21 days starting with a tablet corresponding to that day of the week. Thereafter, one tablet is taken daily, following the arrows marked on the pack, until all tablets have been taken. Each subsequent pack is started the day after the last tablet of the previous pack was taken.
Do not use DIANE-35 if any of the following conditions apply to you:
Idiosyncrasy (including history of hypersensitivity) to any components of Diane-35;
Severe liver damage and liver tumors
Dubin-Johnson and Rotor syndrome (hereditary benign hyperbilirubinemia);
Diseases accompanied by disorders of hemostasis with a tendency to thrombosis, Thromboembolic processes (transient ischemic attack, angina pectoris, cerebrovascular accident, stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism, diabetes mellitus with vascular complications (diabetic microangiopathy)
Sickle cell anemia
Breast cancer and endometrial cancer, hormone-dependent cancers;
Lipid disorders, pancreatitis (including history), unless it was accompanied by severe Hypertriglyceridemia
Idiopathic jaundice during pregnancy, severe pruritus or herpes Progressive otosclerosis during pregnancy Vaginal/uterine bleeding of unspecified etiology
History of migraine, which was accompanied by focal neurological symptoms
Pregnancy and lactation
Diane-35 should not be used by men
Diane-35 contraceptive can be taken only under strict supervision of a physician in the following cases:
- Diabetes mellitus
- Varicose veins
- Multiple sclerosis
Diane-35 is generally well tolerated and does not cause side effects and complications in the most cases. However, some women may experience the following side effects: Hormonal system: a sense of tension and tenderness in the breast, breast enlargement, weight change and sex drive, intermenstrual bleeding, vaginal secretions change.
Central nervous system: headache (migraine), depressed mood.
Gastrointestinal system: nausea, vomiting, stomach pain
Cardiovascular system: high blood pressure.
Dermatological reactions: occurrence of pigment spots on the face (chloasma), growing in long-term exposure to the sun.
Other: allergic reactions in very rare cases there may be a poor tolerance of contact lenses.
The probability of these side effects is increased when taking Diane-35 without professional advice.
If you take Diane-35 you need to know that inductors of microsomal liver enzymes (, barbiturates, primidone, carbamazepine, phenytoin, rifampin, and possibly also with oxcarbazepine, topiramate, increases the clearance of ethinylestradiol and cyproterone, which may lead to vaginal bleedings and loss of contraceptive effect.
Birth control effect of Diane-35 is decreased when the medication is used in combination with certain antibiotics such as ampicillin, tetracycline. Diane 35 may change the blood levels of anti-diabetic medicines.
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.