Diane-35

Other names used:

• Dianette®

Active Ingredients:

• Cyproterone + Ethinylestradiol

How does Diane-35 work and what pharmaceutical group does it belong to?

Diane-35 is a combined low-dose monophase oral hormonal contraceptive with antiandrogenic properties.

Anti-androgens effect of Diane-35. Cyproterone acetate has the ability to competitively bind to receptors of the natural male sex hormones androgens. Cyproterone reduces the influence of androgens, produced in the female body, which allows to treat diseases caused by excessive formation of androgens or an increased susceptibility to them. The therapeutic effect of Diane-35 is manifested in healing acne, preventing the formation of new acne, reduction of excessive sebaceous excretions of the scalp and face.

Contraceptive effect of Diane-35. Diane-35 inhibits ovulation and changes the viscosity of cervical mucus. Along with anti-androgenic properties, cyproterone has gestagen activity, simulating the properties of progesterone. Cyproterone inhibits the secretion of pituitary gonadotrophic hormones and inhibits ovulation. Ethinylestradiol increases central and peripheral effect of cyproterone on ovulation, retains a high viscosity of cervical mucus, making it difficult for sperm to penetrate the uterus and helps to ensure a reliable contraceptive effect.

Which conditions are treated with Diane-35?

• Oral contraception in women with symptoms of androgenization
• Hirsutism (mild form)
• Androgenetical alopecia (hair loss)
• Acne vulgaris

What should a patient know before using Diane-35?

Diane-35 should not be used in cases of:

• Individual intolerance (including a history of hypersensitivity) to any component of Diane-35
• Severe liver disorders and liver tumors
• Hereditary benign hyperbilirubinemia
• Diseases accompanied by disorders of hemostasis with a tendency to thrombosis, thromboembolic processes
• Diabetes mellitus with vascular complications (diabetic microangiopathy)
• Sickle-cell anemia
• Tumors of the breast and endometrium, hormone-dependent cancers
• Endometriosis
• Lipid metabolism disturbances, pancreatitis (including a history) accompanied by severe hypertriglyceridemia
• Idiopathic jaundice in pregnancy, severe itching or herpes of pregnant women in history
• Progressive otosclerosis occurred during pregnancy
• Vaginal / uterine bleeding of unknown etiology
• A history of migraine accompanied by focal neurological symptoms
• Suspected pregnancy, pregnancy and lactation

Diane-35 can be taken only under strict medical supervision in cases of:

• Diabetes mellitus
• Arterial hypertension
• Varicose veins
• Multiple sclerosis
• Epilepsy
• Porphyria
• Tetany
• Rheumatic chorea

Which adverse effects may manifest when using the medication?

The side effects of Diane-35 include:

• tension and soreness in the breasts, breast enlargement, changes in body weight and sex drive, intermenstrual bleeding, change in vaginal secretions
• headache (migraine), depressed mood
• nausea, vomiting, stomach ache
• high blood pressure
• pigmented spots on the face (chloasma)
• allergic reactions
• poor tolerance to contact lenses

It is not necessary that the side effects will manifest in an individual but the possibility still exist. For more information please consult your health care provider.

Which groups of drugs or specific preparations may interact with Diane-35?

The drug is affected by the following:

• microsomal liver enzymes inductors
• some antibiotics
• antidiabetic drugs

Tell your doctor about all the herbal preparations as well as prescription drugs that you are currently taking even if they are not on the list.

Important information for the patient: Diane-35 is supplied for individual use. Do not use it to treat other conditions not listed in the leaflet. Keep the product out of children reach. Do not reuse any disposable materials if supplied with the preparation.