How does Diane-35 work?

DIANE-35 is designed for the treatment of women who suffer from acne or moderately increased growth of facial and body hair (hirsutism). These conditions occur when there is over-production of male type hormones called androgens. DIANE-35 contains two substances that act against the androgens, cyproterone acetate and ethinylestradiol. The main ingredient, cyproterone acetate, causes the body to produce less androgens and blocks the actions of those that are still produced.

While DIANE-35 is being taken, the activity of the sebaceous gland which plays an important role in the development of acne and oily skin or seborrhoea, is reduced. This leads - usually after 3 to 4 months of therapy - to the healing of existing acne. Excessive greasiness of the hair and skin, which often accompanies this condition, generally disappears earlier.

Treatment with DIANE-35 is also useful in women of child-bearing age who have mild forms of hirsutism and in particular slightly increased facial hair although the results do not usually become apparent until several months of use.

Other properties

As well as being an anti-androgen, cyproterone acetate has the properties of a female sex-hormone (progestogen) and its combination with an oestrogen (ethinylestradiol) in DIANE-35 makes the preparation a highly effective oral contraceptive. Therefore, if you normally use a contraceptive method, you will not need to use it while taking DIANE-35 (except in the special circumstances described later). Oral contraceptives must not be used with DIANE-35.

In the treatment of women with polycystic ovary syndrome, DIANE-35 reduces the signs of androgenization, leads to a normalization of the hormone levels, reduces cyst formation and ovarian volume and helps to restore regular menstruation.

What is Diane-35 used for?

DIANE-35 is used for the treatment of androgen-dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), androgenic alopecia and mild forms of hirsutism. It is especially useful for pronounced forms of acne and those accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica).

DIANE-35 is also used for oral contraception in women requiring treatment for these androgenic conditions; it is not recommended just for contraception.

Diane-35 is also indicated for the treatment of polycystic ovary syndrome.







How to use DIANE-35 properly?

DIANE-35 must be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. The dose regimen of DIANE-35 is similar to that of contraceptive pills and the same administration rules must be considered. The irregular intake of DIANE-35 can lead to bleeding between periods and could reduce the therapeutic and contraceptive effect.

The contraceptive protection provided by DIANE-35 is continuous. Additional contraceptive precautions are only required when special circumstances (e.g. forgetting tablets) reduce the reliability of the preparation.

Remember that DIANE-35 has been prescribed for you personally. Do not share it with others.

When and how to take the tablets

The DIANE-35 pack contains 21 tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually it will start on day 2-3 after the last DIANE-35 tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you will have your withdrawal bleed on about the same day each month.

Starting your first pack of DIANE-35

When no hormonal contraceptive has been used in the past month

Start taking DIANE-35 on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the days in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

When changing from a combined Pill

You can start taking DIANE-35 the day after you take the last tablet from your present pill pack (this means no tablet-free break). If your present pill pack also contains non-hormonal tablets you can start DIANE-35 on the day after taking the last hormonal tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present pill (or the day after the last non-hormonal tablet of your present pill).

When changing from a progestogen-only pill (minipill)

You can stop taking the minipill any day and start taking DIANE-35 the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

When changing from an injectable or implant

Start using DIANE-35 when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.






Side effects

Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by DIANE-35.

Serious side effects

Serious reactions associated with the use of DIANE-35, as well as the related symptoms, are described in the section "Before you use DIANE-35" under DIANE-35 and thrombosis and DIANE-35 and cancer.

Other possible side effects

The following side effects have been reported by DIANE-35 users, although they may not be caused by DIANE-35. These side effects may occur in the first few months that you are using DIANE-35 and usually lessen with time.

breast tenderness, pain and secretion
headache
changes in sexual drive; depressive moods
contact lens intolerance
nausea, vomiting and feeling sick
changes in vaginal secretion
various skin reactions
fluid retention
changes in body weight
hypersensitivity reactions