EDVAL 2mg Tablet 28's

Talk to your doctor before taking this medicine, if you: Are allergic to estradiol or any of the other ingredients of this medicine Have or have ever had breast cancer Have cancer, which is sensitive to oestrogens, such as cancer of the womb lining (endometrium) Have any unexplained vaginal bleeding Need to have surgery Have ever had a blood clot in a vein (thrombosis) such as in the legs (deep vein thrombosis) or the lungs (pulmonary embolism) Have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) Have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina Have or have ever had a liver or kidney disease Have a rare blood problem called “porphyria” which is passed down in families (inherited) Have fibroids inside your womb Have growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) Increased risk of getting an oestrogen-sensitive cancer high blood pressure Have diabetes Suffer from gallstones Have a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) Suffer from epilepsy Have a very high level of fat in your blood (triglycerides) If you are pregnant or breast-feeding, think you may be pregnant or planning to have baby, ask your doctor for advice before taking this medicine EDVAL is not for use in adolescents or children

Always take this medicine exactly as your doctor has told you The recommended dose is 2 mg to be taken daily You can take EDVAL with or without food It should be swallowed whole with a glass of water If you take more EDVAL If you have taken more EDVAL, contact your doctor or go to nearest hospital immediately If you forget to take EDVAL If you forget to take EDVAL, take it as soon as you remember If it is almost time for your next dose, skip the missed dose Do not take two doses at the same time If you stop taking EDVAL Do not stop taking this medicine unless your doctor tells you to stop your treatment

Like all medicines, this medicine can cause side effects, although not everybody gets them. Breast or ovarian cancer Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer) Blood clots in the veins of the legs or lungs (venous thromboembolism) Heart disease Stroke Vaginal bleeding at unexpected times (breakthrough bleeding and spotting) Breast pain, tenderness or enlargement, breast discharge painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb Indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease Skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the face some rare skin problems Headache, migraine, dizziness, anxiety or depressive symptoms, fatigue Fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs Fluid retention leading to swelling of parts of the body Changes in body weight and sex drive, increased appetite Muscle cramps, leg pains Nose bleeds, visual disturbances, discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea)

Tell your doctor about any other medicine you are taking: Barbiturates, phenytoin, primidone, carbamazepine and possibly oxcarbazepine, topiramate and felbamate, medicine used to treat epilepsy Rifampicin, rifabutin, medicines used for treating tuberculosis HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir) Griseofulvin, fluconazole, itraconazole, ketoconazole and voriconazole, medicines for treatment of fungal infections Clarithromycin and erythromycin, medicines used for treatment of bacterial infections Verapamil and diltiazem, medicines used for treating high blood pressure

HRT and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Using oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) Using a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy) Discuss with your doctor whether you can safely take this product without a progestogen Irregular bleeding You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of using EDVAL. However, if the irregular bleeding: Carries on for more than the first 6 months Starts after you have been using this medicine for more than 6 months Carries on after you have stopped using this medicine Breast cancer HRT increases the risk of breast cancer For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer Regularly check your breasts. See your doctor if you notice any changes such as: dimpling of the skin, hanges in the nipple,lumps you can see or feel You are advised to take mammography screening test as this medication may increase the density of your breasts where the density of the breast is increased, mammography may not detect all lumps Ovarian cancer The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer Keep this medicine out of reach of children Do not use this medicine after the expiry date Store at room temperature (15-25ºC)