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Simva is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simva raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simva is a member of the class of drugs called statins. Simva is used along with diet if you have: A raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia). A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments. Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simva may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood. In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor. How to use You should stay on a cholesterol-lowering diet while taking Simva. The dose is Simva 10 mg, 20 mg, 40 mg, or 80 mg by mouth once a day. For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day. Your doctor will determine the appropriate dose for you, depending on your condition, your current treatment and your personal risk status. Take Simva in the evening. You can take it with or without food. The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg 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 Simva unless your doctor tells you to stop. If your doctor has prescribed Simva along with any bile acid sequestrant (medicines for lowering cholesterol), you should take SimvaTM at least 2 hours before or 4 hours after taking the bile acid sequestrant. Warnings and precautions Do not take Simva If you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simva Tablets If you currently have liver problems. If you are pregnant or breast-feeding. If you are taking one or more of the following drugs at the same time Take special care with Simva 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. Simva may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking SimvaTM tablets for a short time. Your doctor should do a blood test before you start taking Simva. 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 Simva. Tell your doctor if you have severe lung disease. Side Effects If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital. Muscle pain, tenderness, weakness, or cramps. 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. Inflammation of the blood vessels. Unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing. Shortness of breath and feeling unwell. Storage Information Do not store above 30 ºC. Drug Interactions It is particularly important to tell your doctor if you are taking any of the following drugs. Ciclosporin (a medicine often used in organ transplant patients). Danazol (a man-made hormone used to treat endometriosis). Medicines like itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections). Fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol). Erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections). HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS). Nefazodone (a medicine for depression). Amiodarone (a medicine for an irregular heartbeat). Ingredients The active substance is simvastatin
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