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Diane 35 - Information Sheet
DIANE®35 ED
Cyproterone acetate 2mg and Ethinylestradiol 35mcg tablets
What is DIANE-35 ED used for and how does it work
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.
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 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.
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 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.
What is DIANE-35 ED used for?
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.
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 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.
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 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.
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.
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 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.
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
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.
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
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)
ANY MEDICINE HAS SIDE EFFECTS AFTER A USAGE FOR LONG TIME
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