Indications - Diane-35

Diane-35 is used for the treatment of androgen-dependent diseases in women, such as acne, especially persistent forms and those which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenetic alopecia and mild forms of hirsutism. Diane-35 is also used for oral contraception in women with these androgenic conditions and for the treatment of polycystic ovary syndrome.

Warning

Diane-35 is not for use in men and should not be used in children.

Dosage and directions for use - Diane-35

Before starting Diane-35, a thorough gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out and the family case history carefully noted. In addition, disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembolic diseases (eg deep vein thrombosis, stroke, myocardial infarction) already at a young age. Pregnancy must be excluded. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, an androgen-producing tumour or an adrenal enzyme defect must be excluded in the differential diagnosis. Initial course

The first course of Diane-35 is started on the first day of the cycle (the first day of the menstrual bleeding is counted as day 1 of the cycle). The first tablet should be taken from the starter section of the calendar pack by selecting the appropriate tablet for that day of the week (eg "Mon" for Monday). The tablet is swallowed whole with a little liquid. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day. A tablet is then taken every day in the direction shown by the arrows until the pack is empty.

If the patient is using hormonal contraceptives, the doctor should decide when she should start treatment. The same applies to patients who have just had a delivery or an abortion.
The first cycle may be somewhat shorter than usual, whereas all following cycles will last four weeks.

An additional, non-hormonal method of contraception (with the exception of the rhythm and temperature methods) should be employed during the first 14 days of the first treated cycle.

Subsequent courses After the last tablet has been taken from the first pack, tablet-taking is continued from a new pack on the very next day. The first tablet must again be taken from the starter section of the calendar pack marked with the appropriate day of the week.

Length of use

The length of use depends on the severity of the clinical picture. In general, treatment should be carried out over several months. It is recommended that Diane-35 be taken for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence weeks or months after discontinuation of tablet-taking, treatment with Diane-35 may be resumed.

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 8 th 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.

After having a baby
If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking Diane-35. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take Diane-35, you should discuss this first with your doctor.

Possible side effects

The following side effects have been reported by users of Diane-35, although they need 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.

Known symtoms of overdosage and particulars of its treatment
None.

Identification
21 small beige coated tablets.

Presentation
Calendar packs each containing 21 tablets

Storage Instructions
In original packs at room temperature (below 30?C). Protect from light. Keep out of reach of children. For shelf-life refer to the imprint on the pack.