Diane-35 (Cyproterone Acetate And Ethinylestradiol)

Cyproterone and Ethinyl Estradiol tablets

What is this medicine?

Cyproterone and Ethinyl Estradiol 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). Cyproterone and Ethinyl Estradiol tablets reduce the symptoms of androgen-dependent conditions where oral antibiotic or local treatment alone has not been successful. Cyproterone and Ethinyl Estradiol 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. Cyproterone and Ethinyl Estradiol 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.

What should I tell my health care providers before I take this medicine?

Combination contraceptive pills like Cyproterone and Ethinyl Estradiol tablets 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 I use this medicine?

You should take your Cyproterone and Ethinyl Estradiol tablets swallowed whole with a glass of water once daily at the same time each day and follow the instructions provided. Each pack of Cyproterone and Ethinyl Estradiol tablets contains 21 pills and you should take one tablet a day for 21 days and then you will have 7 days off, during which time you should have a menstrual bleed. When you have had the 7 tablet-free days, start a new pack the next day (day 8) even if you have not stopped bleeding. 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 Cyproterone and Ethinyl Estradiol tablets continually to ensure effective contraception. If you are taking Cyproterone and Ethinyl Estradiol tablets for acne or hirsutism, it may take several months for your skin condition to clear up completely or symptoms to be reduced significantly and you may need to take Cyproterone and Ethinyl Estradiol tablets for several monthly cycles. You should take Cyproterone and Ethinyl Estradiol tablets for as long as your doctor recommends. While you are taking Cyproterone and Ethinyl Estradiol tablets 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.

You should take Cyproterone and Ethinyl Estradiol tablets 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 Cyproterone and Ethinyl Estradiol tablets for a few more months after the acne has disappeared and you should then change to another oral contraceptive.

What happens if I miss a dose?

f you miss a dose of Cyproterone and Ethinyl Estradiol tablets and you are less than 12 hours late in taking a 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 Cyproterone and Ethinyl Estradiol tablets and are more than 12 hours late in taking a tablet, follow these guidelines to help you decide what to do:

• Week 1 - 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 tablets then begin the next pack immediately without a break. You may not have a withdrawal bleed but you are still protected against pregnancy.

What side effects may I notice from this medicine?

The most frequently reported side effects when taking Cyproterone and Ethinyl Estradiol 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.