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Simvastatin belongs to a group of medicines known as statins. These work by reducing the amount of total cholesterol, ‘bad’ cholesterol (LDL cholesterol), and certain fatty substances called triglycerides in your blood. In addition, simvastatin raises levels of ‘good’ cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is used: To lower cholesterol and triglycerides in the blood when a low fat diet and other measures (such as exercise, weight loss) have failed (primary hypercholesterolaemia or mixed hyperlipidaemia). To lower inherited high levels of cholesterol in your blood (homozygous familial hypercholesterolemia), together with dieting and other treatments (e.g. LDL-aphersis), or when such treatments are not appropriate. To reduce the risk of coronary heart disease if you have hardening of the arteries (arteriosclerosis) or diabetes, even if your cholesterol levels are normal, together dieting and other treatments. How to use Take Simvastatin in the evening. You can take it with or without food. The usual starting dose is 10 or 20 mg, in some cases, 40mg a day. Do not take more than 80mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin unless your doctor tells you to stop. If your doctor has prescribed a bile acid sequestrant (another medicine for lowering cholesterol such as colestyramine) along with simvastatin you should take simvastatin at least two hours before or four hours after taking the bile acid sequestrant. Children and adolescents (10-17 years of age) For children (10 -17 years old) with a hereditary illness called familial hypercholesterolaemia, the recommended usual starting dose is 10mg a day in the evening. The maximum recommended dose is 40mg a day. Elderly patients The dose of simvastatin does not need to be changed for elderly patients. Warnings and precautions Do not take Simvastatin: If you are allergic (hypersensitive) to simvastatin or to any of the other ingredients. If you currently have liver problems or a continuous high level of certain liver enzymes (serum transaminases) If you are pregnant or breast-feeding If you are taking one or more of the following medicines at the same time: Ketoconazole, itraconazole or posaconazole (medicines for fungal infections) HIV-protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infections) Erythromycin, clarithromycin or telithromycin (antibiotics for infections) Nefazodone (an antidepressant) Gemofibrozil (a medicine for lowering cholesterol) Ciclosporin (a medicine often used in organ transplant patients) Danazol (a man-made hormone used to treat endometriosis) Take special care with Simvastatin: Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol. Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time. Your doctor should do a blood test before you start taking Simvastatin. This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin. Tell your doctor if you have severe lung disease. Side Effects If any of the following serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital: Muscle aches and pains, tenderness, weakness or cramps. This is because on rare occasions, muscle damage can be serious, including muscle breakdown resulting in kidney damage and very rare deaths have occurred. Hypersensitivity (allergic) reactions including: swelling of the face, tongue and throat which may cause difficulty in breathing Severe muscle pain usually in the shoulders and hips Rash with weakness of limbs and neck muscles Pain or inflammation of the joints Unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing Shortness of breath and feeling unwell. Storage Information Simcor® tablets: Store below 30°C, in the original package, in order to protect from light and moisture. Drug Interactions It is particularly important to tell your doctor if you are taking any of the following drugs. The risk of muscle problems can be greater if simvastatin is taken with the following medicines: Fibrates (other cholesterol-lowering medicines, such as gemfibrozil, bezafibrate). Ciclosporin (drug used to suppress the immune system) Medicines like itraconazole, ketoconazole, fluconazole, posaconazole (antifungals) Erythromycin, clarithromycin and telithromycin (antibiotics). Certain medicines for the treatment of HIV infections (HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir) Danazol (medicine used to treat endometriosis and breast cysts in women) Nefazodone (medicine for depression). Verapamil, diltiazem or amlodipine (medicine used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions). Fusidic acid as a tablet or infusion (a medicine used to treat bacterial infections) Colchicine (a medicine to treat gout). Ingredients The active substance is Simvastatin. The other ingredients are Lactose monohydrate, Maize Starch, Sodium Starch Glycolate, Microcrystalline Cellulose, Citric acid monohydrate, Magnesium Stearate, Bulylated Hydroxy Anisole, Hydroxy Propyl Cellulose, Opadry OYL White, PEG.
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