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INEGY contains the active substances ezetimibe and simvastatin. INEGY is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of “good” cholesterol (HDL cholesterol). INEGY works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class of “statins” inhibits the production of the cholesterol your body makes by itself. INEGY is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. INEGY is used in addition to your cholesterol-lowering diet if you have: A raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia): That is not well controlled with a statin alone For which you have used a statin and ezetimibe as separate tablets A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments. Heart disease, INEGY reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain. How to use The tablets are not scored and should not be divided. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Before starting INEGY, you should be on a diet to lower your cholesterol. You should keep on this cholesterol-lowering diet while taking INEGY. Adults: The dose is 1 tablet INEGY by mouth once a day. Use in adolescents (10 to 17 years of age): The dose is 1 tablet INEGY by mouth once a day (a maximum dose of 10 mg/40 mg once daily must not be exceeded). The INEGY 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. Take INEGY in the evening. You can take it with or without food. If your doctor has prescribed INEGY along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other bile acid sequestrant, you should take INEGY at least 2 hours before or 4 hours after taking the bile acid sequestrant. Warnings and precautions Do not take INEGY if: You are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in Section 6: Contents of the pack and other information) You currently have liver problems You are pregnant or breast-feeding Warnings and precautions Tell your doctor: About all your medical conditions including allergies. If you drink large amounts of alcohol or have ever had liver disease. INEGY may not be right for you. If you are due to have an operation. You may need to stop taking INEGY tablets for a short time. If you are Asian, because a different dose may be applicable to you. Side Effects The following common side effects were reported (may affect up to 1 in 10 people): Muscle aches Elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function Storage Information Store below 30°C. Store in the original package. Drug Interactions Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking INEGY with any of the following medicines can increase the risk of muscle problems Ciclosporin (often used in organ transplant patients) Danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus) Medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections) Fibrates with active ingredients like gemfibrozil and bezafibrate (used to lower cholesterol) Erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet. HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS) Boceprevir or telaprevir (used to treat hepatitis C virus infections) Nefazodone (used to treat depression) Medicines with the active ingredient cobicistat Amiodarone (used to treat an irregular heartbeat) Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions) Lomitapide (used to treat a serious and rare genetic cholesterol condition) Large amounts (1 gram or more each day) of niacin or nicotinic acid (also used to lower cholesterol) Colchicine (used to treat gout). Ingredients The active substances are ezetimibe and simvastatin.
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