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ATOZET is a medicine to lower increased levels of cholesterol. ATOZET contains ezetimibe and atorvastatin. ATOZET is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, ATOZET raises levels of “good” cholesterol (HDL cholesterol). ATOZET works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. ATOZET 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. ATOZET 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. ATOZET reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain. ATOZET does not help you lose weight. How to use How much to take The recommended dose is one ATOZET tablet by mouth once a day. When to take Take ATOZET at any time of the day. You can take it with or without food. If your doctor has prescribed ATOZET along with cholestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take ATOZET at least 2 hours before or 4 hours after taking the bile acid sequestrant. Warnings and precautions Do not take ATOZET if You are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine You have or have ever had a disease that affects the liver You have had any unexplained abnormal blood tests for liver function You are a woman able to have children and are not using reliable contraception You are pregnant, trying to become pregnant or are breast-feeding You use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C. Warnings and precautions Talk to your doctor or pharmacist before taking ATOZET if You have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes You have kidney problems You have an under-active thyroid gland (hypothyroidism) You have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems You have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other “statin” or “fibrate” medicines) You regularly drink a large amount of alcohol You have a history of liver disease You are older than 70 years Side Effects If you experience any of the following serious side effects or symptoms, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department. Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever; skin rash with pink-red blotches especially on palms of hands or soles of feet, which may blister Muscle weakness, tenderness,pain or rupture or red-brown discolouration of urine and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells) You should consult your doctor as soon as possible if you experience problems with unexpected or unusual bleeding or bruising, because this may be suggestive of a liver complaint. The following common side effects were reported (may affect up to 1 in 10 people): Diarrhoea Muscle aches Storage Information Store below 30° C Store in the original package in order to protect from oxygen. Drug Interactions Ciclosporin (a medicine often used in organ transplant patients) Erythromycin, clarithromycin, telithromycin, fusidic acid,** rifampicin (medicines for bacterial infections) Ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections) Gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines for regulating lipid levels) Some calcium channel blockers used for angina or high blood pressure, e.G., amlodipine, diltiazem Digoxin, verapamil, amiodarone (medicines to regulate your heart rhythm) Medicines used in the treatment of hiv, e.G., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (medicines for aids) Ingredients The active substances are ezetimibe and atorvastatin The other ingredients are: calcium carbonate; silica, colloidal anhydrous; croscarmellose sodium; hydroxypropylcellulose; lactose monohydrate; magnesium stearate; cellulose, microcrystalline; polysorbate 80; povidone; sodium laurilsulphate. The film coating contains: hypromellose, macrogol 8000, titanium dioxide (E171), talc. Specifications Capsule-shaped, biconvex, film-coated tablets, white to off white. “333” debossed on one side.
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