Diane-35 ED

Diane 35 general information

What is Diane 35 used for?

Diane 35 tablets are used to treat women with severe signs of androgenisation (overproduction of androgen), that can produce conditions like hirsutism (unwanted hair) and androgenic alopecia (hair loss) both caused by excess androgen production. These conditions are often accompanied by acne, inflammation and seborrhoea (greasy skin from too much sebum). Diane 35 tablets reduce the symptoms of androgen-dependent conditions where oral antibiotic or local treatment alone has not been successful. Diane 35 tablets can also be used for oral contraception at the same time as they are being used to treat androgen-dependent conditions, however, they should not be used for contraception alone. Diane 35 tablets can be used for the treatment of polycystic ovary syndrome, which is also caused by excess androgen and is usually accompanied by acne and hirsutism.

How does Diane 35 work?

Diane 35 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, while at the same time protecting against pregnancy. Although androgens, one of which is testosterone, are considered primarily male hormones, women also produce androgens, although in much smaller amounts. Androgens have several functions in the female body, including 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 hirsutism (unwanted hair) and other unwanted symptoms of androgen overproduction like acne and/or seborrhoea (greasy skin from too much sebum) and androgen-dependent alopecia (hair loss). 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 unit in the skin (contains 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 and hirsutism. The combination of a progestagen (cyproterone) and an oestrogen (ethinyloestradiol) in Diane 35 tablets, provides effective contraception, by blocking ovulation, preventing development of the endometrium so that a fertilised egg would not be able to implant and grow, and preventing the thinning of cervical secretions so that sperm cannot get through.

What does Diane 35 contain?

Diane 35 contains 21 beige tablets with active ingredients consisting of a combination of ethinyloestradiol, a synthetic oestrogen, and cyproterone acetate, which is a progestagen and also an antiandrogen, that work together to reverse the effects of too much androgen, while at the same time protecting against pregnancy. They also contain lactose monohydrate, maize starch, povidone 25 000, magnesium stearate, sucrose, povidone 700 000, macrogol 6000, calcium carbonate, talc, glycerol 85%, titanium dioxide, ferric oxide pigment (yellow), montanglycol wax. Diane 35 also contains 7 white placebo tablets that contain lactose.

Treating acne with Diane 35

Diane 35 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.

Diane 35 for contraception

Diane 35 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, while at the same time protecting against unwanted pregnancy. The combination of a progestagen (cyproterone) and an oestrogen (ethinyloestradiol) in Diane 35 tablets, provides effective contraception, by blocking ovulation, preventing development of the endometrium so that a fertilised egg would not be able to implant and grow, and preventing the thinning of cervical secretions so that sperm cannot get through.

Diane 35 for transgender hormone therapy

Diane 35 tablets contain a combination of ethinyloestradiol, a synthetic oestrogen, and cyproterone acetate, which is a derivative of progestagen and is also an antiandrogen. The cyproterone component can be used as a substitute for spironolactone as the antiandrogen component of transgender feminising hormone therapy for male to female transsexuals, if small doses of antiandrogen are required.

What are the side effects of Diane 35?

The most frequently reported side effects when taking Diane 35 tablets are: breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression. Less common side effects include: migraine, fluid retention, changes in body weight, changes in libido.

When should Diane 35 not be used?

You should not use Diane 35 if you:

• are taking another form of oral contraception, as Diane 35 inhibits ovulation and therefore prevents conception
• are allergic to ethinyloestradiol or cyproterone or any of the ingredients in Diane 35 tablets
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have high blood pressure, lipid disorders or migraine
• have had deep venous thrombosis, thromboembolic disorders, heart attack or stroke
• have diabetes with changes to the blood vessels
• are a diabetic taking antidiabetics or insulin, without discussion with your doctor, as the cyproterone in Diane 35 tablets may affect your glucose tolerance
• have abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are taking other medications that may interact with Diane 35, such as anticonvulsants like phenytoin and carbamazepin, barbiturates, anti-infectives like rifampicin, rifabutin, nevirapine, the antifungal griseofulvin, antibiotics like penicillin, preparations containing St John's Wort

What are the health risks of Diane 35?

Combination contraceptive pills like Diane 35 can increase risk of thrombosis (blood clots), which can have serious consequence depending on where the clot forms. There is also an increased risk of breast cancer.

How should Diane 35 be taken?

You should take your Diane 35 swallowed whole with a glass of water once daily at the same time each day and follow the instructions provided. Each pack of Diane 35 contains 28 pills for a complete monthly cycle and should be taken continually to ensure effective contraception. The first 21 pills contain the contraceptive hormones and the last 7 pills are a placebo, which do not contain any hormones. While you are taking these placebo pills you will have a menstrual bleed. When you have finished one pack, start a new one the next day. If you have gastrointestinal problems like vomiting or diarrhoea within 3-4 hours of taking a tablet, this is the same as missing a pill and you should take other contraceptive precautions for the next 7 days. You should take Diane 35 continually to ensure effective contraception. It may take several months for your skin condition to clear up completely and you should take Diane 35 for as long as your doctor recommends. While you are taking Diane 35 you should not use an additional hormonal contraceptive, as this will expose you to an excessive dose of hormones and is not necessary for effective contraception.

How long should you take Diane 35?

You should take Diane 35 continually to ensure effective contraception and for as long as your doctor recommends. You should expect your acne to clear up completely within a few months, but in particularly severe cases treatment for longer may be necessary before the full benefit is seen. You may be advised to keep taking your Diane 35 tablets for a few more months after the acne has disappeared and you should then change to another oral contraceptive.

Missed dose of Diane 35

If you miss a dose of Diane 35 and are less than 12 hours late in taking your tablet, take it as soon as you remember and take the next one at your usual time. You are still protected against pregnancy.

If you miss a dose of Diane 35 and are more than 12 hours late in taking a tablet, follow these guidelines to help you decide what to do:

• week1 - take the last tablet as soon as you remember and take the next one at your normal time, which may mean taking 2 tablets in one day. Contraceptive protection may be reduced and you are at risk of becoming pregnant, unless you take other contraceptive precautions for the next 7 days.


• Week 2 - take the last tablet as soon as you remember and take the next one at your normal time, which may mean taking 2 tablets in one day. You are not at risk of becoming pregnant and do not need to take extra contraceptive precautions.


• Week 3 - take the last tablet as soon as you remember and take the next one at your normal time, which may mean taking 2 tablets in one day. Take the remaining active beige tablets then skip the white placebo tablets and begin the next pack immediately without a break. You may not have a withdrawal bleed but you are still protected against pregnancy.


• Week 4 – Take the last tablet as soon as you remember and take the next one at your normal time, which may mean taking 2 tablets in one day. These are the placebo tablets and you are not at risk of becoming pregnant and do not need to take extra contraceptive precautions.

How should Diane 35 be stored?

Keep your Diane 35 tablets in their calendar pack until use. Store at room temperature below 25°C.