Diane-35 ED is used for the treatment of signs of androgenisation in women, such as severe acne where other treatments have not been successful, or for excessive growth of facial or body hair (known as hirsutism) of a mild to moderate degree, where no underlying cause has been found.
Diane-35 ED can also be used as a contraceptive to prevent pregnancy in women who are taking it for the treatment of signs of androgenisation as described above. Diane-35 ED contains a progestogen and an oestrogen hormone, and therefore works similarly to the combined oral contraceptive birth control pill, also known as ‘the Pill’. It should not be used in combination with another hormonal contraceptive.
Diane-35 ED tablets contain a combination of ethinyloestradiol, a synthetic oestrogen, and cyproterone acetate, which is a derivative of progestagen and is also an antiandrogen. These two hormones work together to reverse the effects of too much androgen. Although androgens, are primarily male hormones (like testosterone) women also produce androgens, although in much smaller amounts, which are needed for puberty related changes like pubic hair growth, preventing bone loss, libido and for the production of oestrogen. However, some women produce too much androgen and this can cause over production of sebum (oil produced by sebum glands in the skin) which blocks hair follicles causing acne and/or seborrhoea (greasy skin from too much sebum). Cyproterone in Diane 35 tablets blocks the production of androgens by the ovaries and binds to the androgen receptors on specific cells in the pilosebaceous units in the skin (contain sebum-producing sebaceous glands and hair follicles), blocking the androgen-dependent over stimulation of sebum and over production of hair. The ethinyloestradiol component enhances the effect of cyproterone by reducing the amount of androgens in the circulation, relieving symptoms like acne.
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
Side effects: breast pain, tenderness, or swelling, dizziness, headache, vomiting, brown, blotchy spots on exposed skin, nausea, swelling of ankles and feet, increased or decreased interest in sexual intercourse, unusual tiredness or weakness, swelling of ankles and feet, weight gain or loss.
DIANE-35 is supplied in blister pack units consisting of 21 tablets; each tablet containing 2 mg. cyproterone acetate and 0.035 mg ethinyl estradiol. Each cycle consists of 21 days on medication and a 7-day interval without medication (3 weeks on, 1 week off).