Dianette

• For the treatment of acne, hair loss and excessive growth of facial or body hair (hirsutism)
• Contraceptive pill
• For use in women only

Diane-35 contains two sex hormones: cyproterone acetate, a progestogen, and ethinyl estradiol, an oestrogen.

Diane-35 is a contraceptive to prevent pregnancy in women. Diane-35 is also used for the treatment of signs of physical male characteristics caused by the male sex hormone, androgen, produced by in women in small amounts (androgenisation), such as:

• Acne, especially severe acne with oily skin and flaking (seborrhea) or with inflammation or formation of nodules (pustular acne, nodular acne).
• Hair loss caused by excess androgen production (androgenetic alopecia).
• Excessive growth of facial or body hair (known as hirsutism) of a mild to moderate degree.

Cyproterone counteracts the action of male sex hormones, which reduces the symptoms.

Diane-35 is not prescribed for prolonged periods when used solely as a contraceptive. The doctor will tell you how long you need to use this medicine. The length of treatment depends on the severity of the condition. A course of treatment typically takes several months.

Like most other contraceptive pills, Diane-35 is taken for 21 consecutive days with seven days off.

• Take one tablet daily. Follow the arrows that are printed on the back of the strip until all the tablets have been taken.
• After 21 days, you have a seven-day break from pill-taking.
• During this break you will get a withdrawal bleed.
• Always start a new blister pack on day 8, even if you are still bleeding.

The tablets can be taken with or without food at about the same time every day.

Taken too much/forgot to take/stop taking Diane-35

If you swallow too many Diane-35 tablets at the same time, or you think a child may have swallowed some, contact your doctor or pharmacist immediately.

Missed a dose of Diane-35?

• If you miss a tablet and take the missing tablet within 12 hours of missing it, you should still be protected against pregnancy.
• If you are more than 12 hours late, there is risk that Diane-35 is less effective at preventing pregnancy. Whether or not this is the case depends on when and how many pills are missed. If you are more than 12 hours late follow the instructions on the package leaflet.

Note: if you vomit or have severe diarrhoea, the active ingredient may not have been completely absorbed. If you vomit within three to four hours after taking your Diane-35 tablet, follow the instructions for missed tablets. If you have severe diarrhoea, contact your doctor.

Stopping Diane-35: do not stop taking Diane-35 without consulting a doctor first.

Diane-35 is not suitable for everyone and should not be used if:

• You have, or have had, a blood clot in the blood vessels of the legs (deep vein thrombosis), the heart, the lungs (pulmonary embolism) or other parts of the body.
• You have had a recent stroke (caused by a blood clot or blood vessel rupture in the brain).
• You have, or have had, a condition that is linked to an increased risk of heart attack (e.g., angina pectoris or chest pain) or mini-stroke (also known as TIA or transient ischaemic attack).
• You have a history of migraine, where you have also had problems with seeing, speaking or had weakness or numbness in any part of your body.
• You have diabetes with blood vessel damage.
• You have pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood.
• You have jaundice (yellowing of the skin) or a severe liver disease.
• You have, or have had, cancer that may grow under the influence of sex hormones (e.g.,
• 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 may be pregnant.
• You are hypersensitive to any ingredient in Diane-35.

When should this medicine be used with caution?

In some situations, you will need to have regular check-ups while taking Diane-35. Talk to your doctor or pharmacist before taking Diane-35 if:

• You smoke.
• You have diabetes.
• You are overweight.
• You have high blood pressure.
• You have a heart valve disorder or certain heart rhythm disorder.
• You have vein inflammation (superficial phlebitis) or varicose veins.
• Anyone in your immediate family has had thrombosis, a heart attack or stroke.
• You suffer from migraine headaches.
• You have epilepsy.
• You, or anyone in your immediate family, has had high cholesterol or raised levels of triglycerides in the blood.
• Anyone in your immediate family has had breast cancer.
• You have liver disease or gall bladder disease.
• You have Crohn’s disease or ulcerative colitis.
• You have polycystic ovary syndrome.
• You have systemic lupus erythematosus (SLE).
• You have haemolytic uraemic syndrome (HUS).
• You have sickle cell disease.
• You have a condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea).
• You have, or have had, chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face). If so, avoid exposure to the sun or ultraviolet radiation.
• You have hereditary angio-oedema. Exogenous oestrogens can trigger or worsen symptoms of angio-oedema. See your doctor immediately if you experience symptoms of angio-oedema, such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathing.

See the package leaflet for more information and warnings on the use of Diane-35.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or think you may be pregnant, planning a pregnancy or breastfeeding.

Other medicines and Diane-35

Some medicines and Diane-35 may interfere with each other. They may be affected by Diane-35 or make Diane-35 less effective in preventing pregnancy. These include:

• Medicines used to treat epilepsy (e.g., lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate).
• Medicines used to treat tuberculosis (e.g., rifampicin, rifabutin).
• Medicines used to treat HIV (e.g., ritonavir or nevirapine).
• Certain antibiotics (e.g., griseofulvin, penicillin, tetracycline).
• Herbal medicines containing St John’s Wort.
• Cyclosporin, an immunosuppressant medicine.

Tell your doctor if you are taking any other medicines, including any that you get without a prescription. Also be sure to tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine. Your doctor or pharmacist will be able to tell you if and how long you will need to use additional contraceptive methods.

Diane-35 can cause side effects. The following list includes some of the side effects of Diane-35.

• Problems affecting the stomach and intestines.
• Weight gain.
• Headache/migraine.
• Mood changes, including depression.
• Breast tenderness or pain.
• Fluid retention.
• Decreased sex drive.

For a complete list of possible side effects, see the package leaflet.

Women using combination contraceptive pills, such as Diane-35, have an increased risk of thrombosis and certain types of cancer. For more detailed information, see the package leaflet.

Consult a doctor if the side effects are severe or persistent. This includes any possible side effects not listed in this leaflet.

The active ingredients are cyproterone acetate and ethinyl estradiol. Each tablet contains 2 mg of cyproterone acetate and 35 micrograms of ethinyl estradiol.

The other ingredients are: lactose monohydrate, maize starch, povidone 25000, magnesium stearate, sucrose, povidone 700000, macrogol 6000, calcium carbonate, talc, glycerol, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), glycol montanate.

The manufacturer of Diane-35 is:

Bayer Schering Pharma AG D-13342 Berlin
Germany

Read the package leaflet before use.