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EZETROL is a medicine to lower increased levels of cholesterol. EZETROL lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, EZETROL raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe, the active ingredient of EZETROL, works by reducing the cholesterol absorbed in your digestive tract. EZETROL adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. How to use Before starting EZETROL, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet whilst taking EZETROL. The recommended dose is one EZETROL 10 mg Tablet by mouth once a day. Take EZETROL at any time of the day. You can take it with or without food. If your doctor has prescribed EZETROL along with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of that particular medicine. If your doctor has prescribed EZETROL along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other medicine containing bile acid sequestrant, you should take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant. Warnings and precautions Tell your doctor about all your medical conditions including allergies. Your doctor should do a blood test before you start taking EZETROL with a statin. 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 EZETROL with a statin. If you have moderate or severe liver problems, EZETROL is not recommended. The safety and efficacy of the combined use of EZETROL and certain cholesterol lowering medicines, the fibrates have not been established. Side Effects Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment right away) have been reported in general use. When used alone, the following side effects were reported: Common: abdominal pain; diarrhoea; flatulence; feeling tired. Additionally, when used with a statin, the following side effects were reported: Common: elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain, tenderness or weakness. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation, reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia); tingling sensation; depression: unusual tiredness or weakness; shortness of breath. Storage Information Store below 30°C. Store in the original package . Drug Interactions Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients: Ciclosporin (often used in organ transplant patients) Medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants) Colestyramine (also used to lower cholesterol), because it affects the way ezetrol works Fibrates (also used to lower cholesterol) Ingredients The active substance is ezetimibe. The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, sodium laurilsulfate, magnesium stearate. Specifications EZETROL tablets are white to off-white, capsule-shaped tablets with code “414” on one side.
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