Each small hormonal tablet contains a small amount of two different hormones. These are cyproterone acetate (a progestogen with antiandrogenic properties) and ethinylestradiol (an estrogen). Because of the small amounts of hormones, DIANE-35 ED is considered a low-dose preparation. DIANE-35 ED also contains 7 large white non-hormonal tablets that do not contain any active ingredients.

DIANE-35 ED 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 ED 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 ED 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 ED 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.

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 ED 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 ED (except in the special circumstances described later). Oral contraceptives must not be used with DIANE-35 ED.

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

DIANE-35 ED 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 ED is also used for oral contraception in women with these androgenic conditions and for the treatment of polycystic ovary syndrome.

Do not use DIANE-35 ED if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use DIANE-35 ED.

You must not use DIANE-35 ED if:

you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body

you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke)

you have diabetes mellitus with blood vessel damage

you have jaundice (yellowing of the skin) or severe liver disease

you have or have had cancer of the breast or the genital organs

you have or have had a benign or malignant liver tumour

you have any unexplained vaginal bleeding

you are pregnant or think you might be pregnant

you are breast-feeding

you are allergic to any of the ingredients of DIANE-35 ED

If any of these conditions appear for the first time while using DIANE-35 ED, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

If DIANE-35 ED is used in the presence of any of the conditions listed below or they appear for the first time or recur or worsen during treatment, you may need to be kept under close observation. You doctor can explain this to you. You should tell your doctor if:

you smoke

you have diabetes

you are overweight

you have high blood pressure

you have a heart valve disorder or a certain heart rhythm disorder

you have an inflammation of your veins (superficial phlebitis)

you have varicose veins

anyone in your immediate family has had thrombosis, a heart attack or a stroke

you suffer from migraine

you suffer from epilepsy

you or someone in your immediate family have or have had high blood levels of cholesterol or triglycerides (fatty substances)

anyone in your immediate family has had breast cancer

you have liver or gallbladder disease

you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)

you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)

you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys)

you have sickle cell disease

you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation

If you suffer from hirsutism and it has only recently appeared or has lately intensified to a considerable extent the doctor must be informed of this because of the need to determine the cause of the changes.

What else you should know

DIANE-35 ED does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

DIANE-35 ED is not for use in men.

In this leaflet, several situations are described where you should stop taking DIANE-35 ED, or where the reliability of DIANE-35 ED may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because DIANE-35 ED alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

The experience with estrogen/progestogen combinations like DIANE-35 ED is predominantly based on combined oral contraceptives (or "the Pill"). Therefore, the following warnings related to the use of "the Pill" also apply for DIANE-35 ED.

Thrombosis is the formation of a blood clot which may block a blood vessel.

Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the pill. It can also happen if you become pregnant. The risk is higher in pill users than in non-users but not as high as during pregnancy.

Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely, blood clots can occur in the liver, gut, kidney or eye.

Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.

The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke.

When using DIANE-35 ED you should stop smoking, especially if you are older than about 35 years of age.

If you develop high blood pressure while using DIANE-35 ED, you may be told to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilization (for example, when you have your leg or legs in plaster or splints). In women who use the pill (or DIANE-35 ED) the risk may be even higher. Tell your doctor you are using DIANE-35 ED well in advance of any expected hospitalization or surgery. Your doctor may tell you to stop taking DIANE-35 ED several weeks before surgery or at the time of immobilization. Your doctor will also tell you when you can start taking DIANE-35 ED again after you are back on your feet.

Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the ten years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

In rare cases, benign, and even more rarely, malignant liver tumours have been reported in users of the pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen. This finding may not be caused by the pill but may be related to sexual behaviour and other factors. Cervical cancer has been reported to occur more often in women using the pill for a long time.

DIANE-35 can be used together with any of the topical acne treatments. Some oral medicines may stop DIANE-35 ED from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor who prescribes DIANE-35 ED which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use DIANE-35 ED. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

DIANE-35 ED must not be used during breastfeeding.

DIANE-35 ED must not be used by women who are pregnant, or who think they may be pregnant.

There are no observed effects.

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

The contraceptive protection provided by DIANE-35 ED is continuous. Additional contraceptive precautions are only required during your first pack (follow the starting instructions) and when special circumstances (e.g. forgetting tablets) reduce the reliability of the preparation.

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

The DIANE-35 ED pack contains 21 tablets and 7 large white non-hormonal 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 the tablets have been taken. A period (the withdrawal bleed) should begin during the 7 days of taking the large white non-hormonal tablets. Start taking your next pack on the very next day after you have completed your last pack. 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.

When no hormonal contraceptive has been used in the past month

Start taking DIANE-35 ED 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 Monday, take the tablet marked Monday from the red section of the pack. Then follow the days in order of the directional arrows. If you start taking DIANE-35 ED towards the end of the week, your very first cycle may be shorter than usual.

When you start taking DIANE-35 ED you must use an additional method of contraception such as condoms or a diaphragm for the first 14 days of your first pack. The rhythm, temperature and cervical mucus methods are not suitable for this purpose.

You can start taking DIANE-35 ED 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 ED on the day after taking the last hormonal tablet (if you are not sure which this is, ask your doctor or pharmacist).

You can stop taking the minipill any day and start taking DIANE-35 ED the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 14 days of tablet-taking when having intercourse.

Start using DIANE-35 ED 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 14 days of tablet-taking when having intercourse.

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 ED. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take DIANE-35 ED, you should discuss this first with your doctor.

Your doctor will advise you.

The following describes special circumstances which could alter the way you take DIANE-35 ED. In all situations where the reliability of DIANE-35 ED is reduced (such as missing tablets) additional contraceptive precautions are required following the advice given below. This advice should also be followed in situations where other medicines may stop DIANE-35 ED from working properly and in the case of vomiting after taking DIANE-35 ED.

If you forget to take your tablets follow the instructions below. This is often called the "7-day rule". The more tablets you have missed, the higher the risk that the contraceptive effect is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack.

If you have forgotten to take one or more of the large white non-hormonal tablets – there is no need to be concerned, simply take your next tablet, the next day as usual.

If you are less than 12 hours late in taking one of the small hormonal Diane-35 ED tablets, you are still protected against pregnancy. Take the tablet as soon as you remember and take the next one at your usual time. This may mean that you are taking 2 tablets in one day.

If you are more than 12 hours late in taking one of your small hormonal Diane-35 ED tablets you will not be protected. Take the last tablet as soon as you remember and take the next one at your normal time. This may mean taking 2 tablets in one day. You must take extra contraceptive precautions and you must follow the 7 day rule. Read the section on " Extra contraceptive precautions " and "The 7 day rule " carefully.

If you forgot tablets in the first week of taking the small hormonal tablets in your pack and had intercourse in the seven days before, consult your doctor as the possibility of pregnancy should be considered.

If you have forgotten to take your small hormonal Diane-35 ED tablets for a few days, consult your doctor to be sure you are not pregnant, then discard the missed tablets and follow the 7 day rule.

Extra contraceptive precautions

When you need extra contraceptive precautions, either:

don't have sex; or

use a cap plus spermicide; or

use a condom

Do not use the rhythm or temperature methods as extra contraceptive precautions. This is because oral contraceptives alter the usual menstrual cycle changes such as changes in temperature and cervical mucus.

Continue taking your pills.

You will not be protected from pregnancy until you have taken your daily small hormone pill for the next 7 days in a row.

Use another method of contraception (extra contraceptive precautions) such as condoms or do not have sexual intercourse for the next 7 days while taking the next 7 small hormone pills

If there are fewer than 7 small hormone pills left in the pack, finish the hormone pills and go straight on to the small hormone pills of the next pack. This means that you miss out on the large non-hormonal pills. You may not have a period until the end of the next pack. This is not harmful

If you vomit after taking DIANE-35 ED

If you vomit within 3 to 4 hours after taking your DIANE-35 ED, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

Some oral medicines may stop DIANE-35 ED from working properly. These medicines are listed in an earlier section. For the time that you are taking the medicine and for the next 7 days follow the advice for missed tablets. If you are taking rifampicin, or you are taking these medicines continuously, your doctor will advise you on the length of time you need to take extra contraceptive precautions

You can delay your period if you miss out the large non-hormonal tablets and go straight to the small hormonal tablets in your next pack. Continue with this pack until this pack is empty. Your period will start while you are taking the large white non-hormonal tablets in the next pack. You may have some breakthrough bleeding or spotting while you are taking the small hormonal tablets.

If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the duration of taking the non-hormonal tablets. If you make the duration of taking the large non-hormonal tablets very short (e.g. 3 days or less), you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

As with other pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) with DIANE-35 ED between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to DIANE-35 ED (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take DIANE-35 ED as usual.

If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of DIANE-35 ED until your doctor has checked you are not pregnant.

There have been no reports of serious harmful effects from taking too many DIANE-35 ED tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken DIANE-35 ED, ask your doctor for advice.When using DIANE-35 ED

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a blood clot while you are taking DIANE-35 ED. Warning signs to look out for are:

an unusual cough

severe pain in the chest which may reach the left arm

breathlessness

any unusual, severe, or prolonged headache or migraine attack

partial or complete loss of vision, or double vision

slurring or speech disability

sudden changes to your hearing, sense of smell, or taste

dizziness or fainting

weakness or numbness in any part of your body

severe pain in your abdomen

severe pain or swelling in either of your legs

Tell your doctor if:

Contact your doctor as soon as possible if:

you notice any changes in your own health, especially involving any of the items mentioned in this leaflet; do not forget about the items related to your immediate family

you feel a lump in your breast

you are going to use other medications

you are to be immobilized or are to have surgery (consult your doctor at least four weeks in advance)

you have unusual, heavy vaginal bleeding

you forgot tablets in the first week of the pack and had intercourse in the seven days before

you miss your period twice in a row or suspect you are pregnant (do not start the next pack until told to by your doctor)

Regular check-ups

When you are using DIANE-35 ED, your doctor will tell you to return for regular check-ups. In general, you should have a check-up every year.

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 to take DIANE-35 ED 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 ED may be resumed. Your doctor is likely to recommend a longer period of treatment for the polycystic ovary syndrome.

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 ED.

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

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

Storage

Do not use after the expiry date stated on the package.

Store all medicines properly and keep them out of reach of children.

Like other combined oral contraceptive pills, DIANE-35 ED may also have non-contraceptive health benefits.

Your period may be lighter and shorter. As a result, the risk of anaemia may be lower. Your period pains may become less severe or may completely disappear.

Some serious disorders have been reported to occur less frequently in users of oral contraceptive pills. These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose pills such as DIANE-35 ED.

DIANE-35 ED tablets contain:

active substances (per tablet)

cyproterone acetate (2 mg) and ethinyl estradiol (0.035 mg)

other substances

lactose monohydrate, maize starch, polyvidone 25 000, magnesium stearate, sucrose, polyvidone 700 000, macrogol 6000, calcium carbonate precipitated, talc, glycerol 85%, titanium dioxide, ferric oxide (pigment yellow), montanglycol wax

If you have any further questions please consult your doctor or pharmacist.