Product Details

WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANE 35

Before you take Diane 35

It’s important that you understand the benefits and risks of taking Diane 35 before you start taking it, or when deciding whether to carry on taking it. Although Diane 35 is suitable for most healthy women it isn’t suitable for everyone. → Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet. Before you start taking Diane 35 ➢ Your doctor will ask about you and your family’s medical problems and check your blood pressure and exclude the likelihood of you being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you or if you have any special concerns. While you’re on Diane 35 ➢ You will need regular check-ups with your doctor, usually when you need another prescription of Diane 35. ➢ You should go for regular cervical smear tests. ➢ Check your breasts and nipples every month for changes – tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin. ➢ If you need a blood test tell your doctor that you are taking Diane 35, because this type of medicine can affect the results of some tests. ➢ If you’re going to have an operation, make sure your doctor knows about it. You may need to stop taking Diane 35 at least 4 weeks before the operation. This is to reduce the risk of a blood clot (see section 2.1). Your doctor will tell you when you can start taking Diane 35 again. ➢ If you need to stop taking Diane 35, remember to use another contraceptive (e.g. condoms) if you are relying on Diane 35 for contraception. When should you contact your doctor Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described below in ‘Blood clots (Thrombosis)’ and in Section 4. Diane 35 also works as an oral contraceptive. You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives. Blood clots (thrombosis) Taking Diane 35 may slightly increase your risk of having a blood clot (called a thrombosis). Your chances of having a blood clot are only increased slightly by taking Diane 35 compared with women who do not take Diane 35 or any contraceptive pill. A full recovery is not always made and in 1-2% of cases, can be fatal. Blood clots in a vein V042_0 4 A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in veins of the leg, the lung (a lung embolus), or any other organ. Using a combined pill increases a woman’s risk of developing such clots compared with a woman not taking any combined pill. The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy. Your chances of having a blood clot are only increased slightly by taking Diane 35. ➢ Of 100,000 women who are not taking Diane 35, not on the Pill and not pregnant, about 5 to 10 will have a blood clot in a year. ➢ Of 100,000 women who take Diane 35 or the Pill, up to 40 will have a blood clot in a year. ➢ Of 100,000 women who are pregnant, around 60 will have a blood clot in a year The risk of blood clots in a vein in users of a combined pill increases further: • with increasing age; • if you smoke. When using a hormonal contraceptive like Diane 35 you are strongly advised to stop smoking, especially if you are older than 35 years; • if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age; • if you are overweight; • if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast; • if you have polycystic ovary syndrome; • if you have recently had a baby; • if you have certain rare medical conditions such as systemic lupus erythematosus, Crohn’s disease or ulcerative colitis; • if you have sickle cell disease. If this applies to you, it is important to tell your doctor that you are using Diane 35, as the treatment may have to be stopped. Your doctor may tell you to stop using Diane 35 at least 4 weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Diane 35 again after you are back on your feet. Blood clots in an artery A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke. The use of a combined pill has been connected with an increased risk of clots in the arteries. This risk increases further: V042_0 5 • with increasing age; • if you smoke. When using a hormonal contraceptive like Diane 35 you are strongly advised to stop smoking, especially if you are older than 35 years; • if you are overweight; • if you have high blood pressure; • if a close relative has had a heart attack or stroke at a young age; • if you have a high level of fat in your blood (cholesterol or triglycerides); • if you get migraines; • if you have a problem with your heart (valve disorder, disturbance of the rhythm); • if you have polycystic ovary syndrome; • if you have diabetes; • if you have certain rare medical conditions such as systemic lupus erythematosus; • if you have sickle cell disease. Symptoms of blood clots See a doctor straight away if you also develop severe depression, a severe allergic reaction, worsening of hereditary angioedema, signs of breast cancer or cervical cancer or signs of severe liver problems (symptoms and signs are described in section 4). Diane 35 and cancer Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot, such as: • an unusual sudden cough; • severe pain in the chest which may reach the left arm; • breathlessness; • any unusual, severe, or long-lasting headache or worsening of migraine; • 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. Following a blood clot, recovery is not always complete. Rarely serious permanent disabilities may occur or the blood clot may even be fatal. Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking Diane 35. V042_0 6 While high dose COCs reduce your risk of cancer of the ovary and womb if used in the long term, it is not clear whether lower dose oestrogen-progestogen containing Pills like Diane 35 also provide the same protective effects. However, it also seems that taking Diane 35 slightly increases your risk of cancer of the cervix – although this may be due to having sex without a condom, rather than Diane 35. All women should have regular smear tests. If you have breast cancer, or have had it in the past, you should not take Diane 35 or other oral contraceptives, as they slightly increase your risk of breast cancer. This risk goes up the longer you’re on Diane 35, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Diane 35 users is small. For example: ➢ Of 10,000 women who have never taken Diane 35 or the Pill, about 16 will have breast cancer by the time they are 35 years old. ➢ Of 10,000 women who take Diane 35 or the Pill for 5 years in their early twenties, about 17–18 will have breast cancer by the time they are 35 years old. ➢ Of 10,000 women who have never taken Diane 35 or the Pill, about 100 will have breast cancer by the time they are 45 years old. ➢ Of 10,000 women who take Diane 35 or the Pill for 5 years in their early thirties, about 110 will have breast cancer by the time they are 45 years old. Your risk of breast cancer is higher: ➢ if you have a close relative (mother, sister or grandmother) who has had breast cancer ➢ if you are seriously overweight → See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel. ➢ Taking Diane 35 has also been linked to liver diseases, such as jaundice and noncancer liver tumours, but this is rare. Very rarely, Diane 35 has also been linked with some forms of liver cancer in women who have taken it for a long time. → See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes (jaundice). You may need to stop taking Diane 35. For high doses (25mg and above) of cyproterone acetate an increased risk of benign brain tumour (meningioma) has been reported. If you are diagnosed with meningioma, your doctor will stop all cyproterone containing products, including Diane 35 as a precautionary measure (see section 2.2 ‘Make sure Diane 35 is ok for you’). 2.2 Make sure Diane 35 is OK for you Diane 35 should not be taken by some women → Tell your doctor if you have any medical problems or illnesses. V042_0 7 Do not use Diane 35 Tell your doctor if any of the following conditions applies to you before starting to use Diane 35. Your doctor may then advise you to use a different treatment: ➢ If you are using another hormonal contraceptive ➢ If you are pregnant or might be pregnant ➢ If you are breast-feeding ➢ If you have or have ever had breast cancer ➢ If you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body. ➢ If you have (or have ever had) a disease that may be an indicator of a heart attack in the future (e.g. angina pectoris which causes severe pain in the chest) or ‘ministroke’ (transient ischaemic attack) ➢ If you have (or have ever had) a heart attack or stroke. ➢ If you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions: o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides) ➢ If you have problems with blood clotting (e.g. protein C deficiency) ➢ If you have (or have ever had) a migraine, with visual disturbances ➢ If you have ever had a severe liver disease, and you have been told by your doctor that your liver test results are not yet back to normal ➢ If you have ever had liver tumours ➢ If you have meningioma or have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull) ➢ If you are allergic (hypersensitive) to any of the ingredients in Diane 35. Do not use Diane 35 if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir / velpatasvir / voxilaprevir (see also in section ‘Taking other medicines’). → If you suffer from any of these, or get them for the first time while taking Diane 35, contact your doctor as soon as possible. Do not take Diane 35. If needed, use another form of contraception. Diane 35 can make some illnesses worse Some of the conditions listed below can be made worse by taking Diane 35. Or they may mean it is less suitable for you. You may still be able to take Diane 35 but you need to take special care and have check-ups more often. ➢ If you or your close family have ever had problems with your heart or circulation, such as high blood pressure ➢ If you or your close family have ever had problems with blood clotting ➢ If you have had migraines ➢ If you are currently suffering from depression or have done so in the past ➢ If you are overweight (obese) V042_0 8 ➢ If you have the inherited disease called porphyria ➢ If you have diabetes ➢ If you have inflammation of the pancreas (pancreatitis), or a history or family history of high levels of fat in your blood (hypertriglyceridemia), as you may be at risk of developing pancreatitis ➢ If you have brown patches on your face or body (chloasma) (see below ‘Diane 35 and sun-beds or sun-lamps’) ➢ If you have any illness that worsened during pregnancy or previous use of the Pill or Diane 35 (see section 4) ➢ If you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema. Diane 35 may increase the risk of gallstone formation and may worsen existing disease → Tell your doctor if any apply to you. Also tell them if you get any of these for the first time while taking Diane 35, or if any get worse or come back, because you may need to stop taking it. Psychiatric disorders: Some women using hormonal contraceptives including Diane 35 have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible. Taking other medicines Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives. If you are taking Diane 35 for skin treatment, you must not take any other hormonal contraceptive at the same time. Some medicines: • can have an influence on the blood levels of Diane 35 and • can make it less effective in preventing pregnancy, or • can cause unexpected bleeding. Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you take Diane 35. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed. V042_0 9 These include: • medicines used for the treatment of o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (e.g. rifampicin) o HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) o fungal infections (e.g. griseofulvin, ketoconazole) o arthritis, arthrosis (etoricoxib) o high blood pressure in the blood vessels in the lungs (bosentan) • the herbal remedy St. John’s wort If you do need to take one of these medicines, Diane 35 may not be suitable for you or you may need to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long. Diane 35 may influence the effect of other medicines, e.g. • medicines containing ciclosporin • the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures) • theophylline (used to treat breathing problems) • tizanidine (used to treat muscle pain and/or muscle cramps). Your doctor may need to adjust the dose of your other medicine. In addition, Diane 35 can also interfere with the results of some blood tests, so always tell your doctor that you are taking Diane 35 if you have a blood test. Do not use Diane 35 if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir / velpatasvir / voxilaprevir as these products may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Diane 35 can be restarted approximately 2 weeks after completion of treatment. See section ‘Do not use Diane 35…’. Taking Diane 35 with food and drink There are no special instructions about food and drink while on Diane 35. Pregnancy and breast-feeding Do not use Diane 35 if you are pregnant or are breast-feeding. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Diane 35. V042_0 10 Driving and using machines Diane 35 has no known effect on the ability to drive or use machines. Diane 35 contains lactose and sucrose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before using Diane 35. Diane 35 and sun-beds or sun-lamps Sun-lamps are used by some women for acne as well as to tan the skin. This is not a very useful treatment for acne. Do not use sun-beds or sun-lamps and avoid prolonged sunbathing if you are taking Diane 35. Their use increases the chance of chloasma, a patchy discolouration of the skin (as it does with ordinary oral contraceptives).