A PRESCRIPTION IS REQUIRED FOR DIANE 35
This medicine is an estrogen and progestin combination used to prevent pregnancy. It may also be used to regulate the menstrual cycle, treat symptoms of menopause, or treat other conditions as determined by your doctor.TRY TO TAKE THIS MEDICINE at the same time every day, not more than 24 hours apart. STORE THIS MEDICINE at room temperature, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. IF YOU MISS MORE THAN 1 DOSE OF THIS MEDICINE, refer to the patient information that came with this medicine.
Do not use DIANE-35 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. You must not use DIANE-35 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),
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, if you have or have had a benign or malignant liver tumour, if you have any unexplained vaginal bleeding you are pregnant or think you might be pregnant or if
you are breast-feeding, if you are allergic to any of the ingredients of DIANE-35. If any of these conditions appear for the first time while using DIANE-35, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.
Tell your doctor if:
If DIANE-35 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 or anyone in your immediate family has had thrombosis, a heart attack or a stroke. 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 does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
DIANE-35 is not for use in men.
In this leaflet, several situations are described where you should stop taking DIANE-35, or where the reliability of DIANE-35 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 alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
The experience with estrogen/progestogen combinations like DIANE-35 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.
DIANE-35 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 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, 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) the risk may be even higher. Tell your doctor you are using DIANE-35 well in advance of any expected hospitalization or surgery. Your doctor may tell you to stop taking DIANE-35 several weeks before surgery or at the time of immobilization. Your doctor will also tell you when you can start taking DIANE-35 again after you are back on your feet.
DIANE-35 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.
DIANE-35 and other medicines
DIANE-35 can be used together with any of the topical acne treatments. Some oral medicines may stop DIANE-35 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 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. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
DIANE-35 and breastfeeding
DIANE-35 must not be used during breastfeeding.
DIANE-35 and pregnancy
DIANE-35 must not be used by women who are pregnant, or who think they may be pregnant.
DIANE-35 and ability to drive
There are no observed effects.