Diane-35 ED is used for the treatment of signs of androgenisation in women, such as severe acne where other treatments have not been successful, or for excessive growth of facial or body hair (known as hirsutism) of a mild to moderate degree, where no underlying cause has been found.
Diane-35 ED can also be used as a contraceptive to prevent pregnancy in women who are taking it for the treatment of signs of androgenisation as described above. Diane-35 ED contains a progestogen and an oestrogen hormone, and therefore works similarly to the combined oral contraceptive birth control pill, also known as ‘the Pill’. It should not be used in combination with another hormonal contraceptive.
While taking Diane-35 ED you may also experience the following benefits:
- more regular and lighter periods – potentially resulting in a decrease in anaemia (iron deficiency)
- a decrease in period pain
- reduction of greasiness in skin and hair.
Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy, fibrocystic breast changes and cancer of the uterus (womb) and ovaries may be less common in women taking Diane-35 ED.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
BEFORE YOU TAKE DIANE-35 ED
When you must not take it
Do not take Diane-35 ED if you have an allergy to:
- ethinyloestradiol and/or cyproterone acetate (the active ingredients in Diane-35 ED)
- any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty in breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not take Diane-35 ED if you have, or have had, a blood clot in:
- the blood vessels of the legs (deep vein thrombosis – DVT)
- the lungs (pulmonary embolism – PE)
- the heart (heart attack)
- the brain (stroke)
- other parts of the body.
Do not take Diane-35 ED if you are concerned about an increased risk of blood clots.Blood clots are rare. Very occasionally blood clots may cause serious permanent disability and may even be fatal.
All combined oral contraceptive pills, including Diane-35 ED, increase the risk of having a blood clot. However, the risk of having a blood clot when taking the Pill is less than the risk of having a blood clot during pregnancy.
Do not take Diane-35 ED if you are concerned about an increased risk of blood clots because of age or smoking. The risk of having a heart attack or stroke increases as you get older. It also increases if you smoke. You should stop smoking when taking Diane-35 ED, especially if you are older than 35 years of age.
Do not take Diane-35 ED if you have, or have had:
- angina (chest pain)
- a mini-stroke (also known as TIA or transient ischaemic attack)
- migraine, accompanied by visual symptoms, speech disability, or weakness or numbness in any part of your body
- diabetes mellitus with blood vessel damage
- pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
- severe liver disease and your liver function has not returned to normal
- cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
- a benign or malignant liver tumour
- unexplained vaginal bleeding.
If any of these conditions appear for the first time while using the Pill, stop taking it at once and tell your doctor. In the meantime use non-hormonal (barrier) methods of contraception (such as condoms or a diaphragm).
Do not take Diane-35 ED if you are using another hormonal contraceptive.
Do not take this medicine if you are pregnant or think you might be pregnant.
Do not breast-feed if you are taking this medicine.
Do not give this medicine to a child.
Do not take this medicine after the expiry date printed on the pack and blister. The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.
Do not take this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if:
- you smoke
- you, or anyone in your immediate family has had blood clots in the legs (DVT), a heart attack, a stroke, breast cancer or high cholesterol.
Tell your doctor if you have or have had any of the following medical conditions:
- high blood pressure
- heart valve disorders or certain heart rhythm disorders
- inflammation of your veins (superficial phlebitis)
- varicose veins
Ask your doctor to check if you:
- are overweight
- have high cholesterol or triglycerides
- have liver disease
- have gall bladder disease
- have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
- have systemic lupus erythematosus (SLE – a disease affecting the skin all over the body)
- have haemolytic uraemic syndrome (HUS – a disorder of blood coagulation causing failure of the kidneys)
- have sickle cell disease
- 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)
- have chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid exposure to the sun or ultraviolet radiation
- have hereditary angio-oedema – you should 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.
If any of the above conditions appear for the first time, recur, or worsen while taking Diane-35 ED, you should contact your doctor.
Diane-35 ED contains lactose. If you have an intolerance to some sugars, contact your doctor before you start taking Diane-35 ED.
If you have not told your doctor about any of the above, tell him/her before you start taking Diane-35 ED.