Estradiol, Cyproterone tablets What Estradiol, Cyproterone is and what it is used for • This medicine contains an estrogen and an anti-androgen. • It is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate. • You should only take this medicine if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics. • If you are taking this medicine for skin treatment, you must not take any other hormonal contraceptive at the same time. • When your skin condition has cleared up and you stop taking this medicine, you will need to go back to your original/preferred method of contraception. • Treating skin conditions Androgens are hormones that stimulate hair growth and the grease glands in your skin. If you produce too much androgen, or if you are sensitive to the effect, the grease glands may produce too much sebum. This can block the grease glands, which can become infected and inflamed causing acne spots. It stops the androgens affecting your skin and reduces the amount of androgens produced. • Contraception This medicine is a 21-day Pill – you take one each day for 21 days, followed by 7 days when you take no pills. This medicine will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this. • This medicine needs to be taken as directed to prevent pregnancy. What you need to know before you use Estradiol, Cyproterone Do not use Estradiol, Cyproterone Tell your doctor if any of the following conditions applies to you before starting to use This medicine. 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 breastfeeding • 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 ‘mini-stroke’ (transient ischemic 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 tumors • If you have meningioma or have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull) • If you are allergic (hypersensitive) to any of the ingredients in This medicine. Warnings and precautions You should let your doctor know: • 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) • 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) • If you have any illness that worsened during pregnancy or previous use of the Pill or This medicine Other medicines and Estradiol, Cyproterone Inform your doctor about the medicines you are taking, especially mention to you doctor if you are taking: • If you are taking This medicine for skin treatment, you must not take any other hormonal contraceptive at the same time. • 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 non-nucleoside 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 • 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) How to use Estradiol, Cyproterone Your doctor has chosen This medicine as a treatment for your acne or excessive hair growth on your face and body. However, This medicine also has a contraceptive effect, so it is important to follow the advice below if you are relying on This medicine for contraception. If you are only using This medicine for your acne or excessive hair growth, you can still follow this advice, but ask your doctor if you are unsure. Duration of use Your doctor will tell you how long you need to keep taking This medicine. How to take it Take This medicine every day for 21 days This medicine comes in strips of 21 pills, each marked with a day of the week. • Take your pill at the same time every day. • Start by taking a pill marked with the correct day of the week. • Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills. • Swallow each pill whole, with water if necessary. Do not chew the pill. Then have seven pill-free days After you have taken all 21 pills in the strip, you have seven days when you take no pills. Possible side effects Stop using the product and seek immediate medical attention if • Swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing • Severe depression • Signs of blood clot How to store Estradiol, Cyproterone • Keep all medicines out of the reach and sight of children. • Do not store above 25°C. • Do not use This medicine after the expiry date shown on the strip. • Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment. A valid prescription should be available upon delivery

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