Consumer Medicine Information

DIANE^®35 ED

Cyproterone acetate 2mg and Ethinylestradiol 35mcg tablets

What is in this leaflet

Please read this leaflet carefully before you start using DIANE-35 ED. It will advise you about how to take DIANE-35 ED properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist.

What is DIANE-35 ED used for and how does it work

Each small active 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 inactive (placebo) tablets that do not contain any active ingredients.

How does DIANE-35 ED work?

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 glands which play 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.

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 estrogen (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.

What is DIANE-35 ED used for?

DIANE-35 ED 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 seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica).

DIANE-35 ED is also used for oral contraception in women requiring treatment for these androgenic conditions; it is not recommended just for contraception. DIANE-35 ED is also indicated for the treatment of polycystic ovary syndrome.

Before you use DIANE- 35 ED

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 had a stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• 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 ischemic attack or small reversible stroke)
• you have a history of migraine accompanied by e.g. visual symptoms, speech disability or weakness or numbness in any part of your body
• you have diabetes mellitus with blood vessel damage
• you have or have had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
• 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 tumor
• you have any unexplained vaginal bleeding
• you are pregnant or think you might be pregnant
• you are breast-feeding
• you are hypersensitive (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.

Tell your doctor if:

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 polycystic ovary syndrome (a disorder of your ovaries that may affect fertility). Your doctor may have prescribed DIANE-35 ED for this condition but you should also be aware that there may be an increased risk of thrombosis with this condition
• you have had a medical condition that occurred for the first time or worsened during pregnancy or previous use of the Pill
• you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)
• you have hemolytic uremic 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, your 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.

DIANE-35 ED and thrombosis

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.

If you notice possible signs of thrombosis, stop taking DIANE-35 ED and consult your doctor immediately (see also "When using DIANE-35ED").

DIANE-35 ED and cancer

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 tumors have been reported in users of the Pill. These tumors 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.

The most important risk factor for cervical cancer is persistent human papilloma virus infection. Some studies have suggested that the long-term use of oral contraceptives might increase this risk further. However, it is also possible that other factors such as sexual behaviour and the use of barrier contraceptives might have influenced the study results.

DIANE-35 ED and other medicines

DIANE-35 ED 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, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. rifampicin rifabutin) and HIV infections (e.g. ritonavir); antibiotics (e.g. penicillins, tetracyclines, griseofulvin) for some other infectious diseases and the herbal remedy St John's wort (primarily used for the treatment of depressive moods). DIANE-35 may also interfere with the working of other medicines.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, even those not prescribed. 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 and breastfeeding

DIANE-35 ED must not be used during breastfeeding.

DIANE-35 ED and pregnancy

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

DIANE-35 ED and ability to drive and use machines

There are no observed effects.

DIANE-35 ED and laboratory tests

DIANE-35 ED may influence the results of some laboratory tests.

How to use DIANE-35 ED properly

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.

When and how to take the tablets

The DIANE-35 ED pack contains 21 tablets and 7 large white inactive 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 inactive 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.

Starting your first pack of DIANE-35 ED

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 from the red section of the pack. For example, if your period starts on a Friday, take the tablet marked Friday 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 non-hormonal 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.

Changing from another combined oral contraceptive (COC)

You can start taking DIANE-35 ED the day after you take the last active tablet from your present pill pack. If your present pill pack contains inactive (placebo) tablets, you should throw away the inactive tablets and start DIANE-35 ED on the day after taking the last active tablet from your present pack (if you are not sure which this is, ask your doctor or pharmacist). This means no tablet free break. If you follow these instructions, it is not necessary to use an additional contraceptive method. A withdrawal bleed may not occur until the end of the first pack of DIANE-35ED.

When changing from a progestogen-only pill (minipill)

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.

When changing from an injectable or implant

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.

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 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.

After a miscarriage or an abortion

Your doctor will advise you.

Special circumstances

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, such as with severe diarrhea, or in the case of vomiting after taking DIANE-35 ED.

If you forget to take your tablets

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 vomit or have diarrhea 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. The same advice should be followed in the case of severe diarrhea.

If you are taking medicines that affect DIANE-35 ED

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

If you want to delay a period

You can delay your period if you miss out the large inactive tablets and go straight to the small active 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 inactive tablets in the next pack. You may have some breakthrough bleeding or spotting while you are taking the small active tablets.

If you want to change the starting day of your period

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 inactive tablets. If you make the duration of taking the large inactive tablets very short (e.g. 3 days or less), you may not have any bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

If you have unexpected bleeding

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 missed a period

If you have taken all of your tablets at the right time, and you have not vomited, had diarrhea, 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.

Overdosage

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
• an increase in the number of migraines, or any unusual, severe, or prolonged headache or migraine attack
• an increase in the number of migraines that you have
• 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
• movement disturbances
• 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 taking active tablets immediately after taking the inactive tablets and had intercourse in the seven days before
• you have severe diarrhea
• 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.

For how long should DIANE-35 ED be used?

The length of use depends on the severity of your symptoms and their response to treatment. In general, treatment should be carried out over several months. Acne and seborrhea usually respond sooner than hirsutism or alopecia.

It is recommended to take DIANE-35 ED for at least another 3 to 4 cycles after your symptoms 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 polycystic ovary syndrome.

Side effects

Serious side effects

Like all medicines, DIANE-35 ED can have 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 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.

Other possible side effects

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.

Storage

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

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

Store below 30°C

Further information

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 anemia 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, povidone 25 000, magnesium stearate, sucrose, povidone 700 000, macrogol 6000, calcium carbonate, talc, glycerol 85%, titanium dioxide, ferric oxide pigment (yellow), montanglycol wax.

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

Name and Address

Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore
AUCKLAND 0627

Free Phone:  0800 233 988

Date of Preparation

1st February 2007