Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ezetimibe
Alliance Healthcare (Distribution) Ltd
C10AX09
Ezetimibe
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000
Proof no. Colours: Dimensions: Date prepared: Font size: Fonts: 010.0 07/02/2019 10pt Black 165 x 620 mm FuturaCEEF ARTWORK PROOF BOX Ref: V022: Change in pharmaceutical form & change to inprocess tests Ezetimibe is a medicine to lower increased levels of cholesterol. Ezetimibe lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, this medicine raises levels of "good" cholesterol (HDL cholesterol). Ezetimibe, the active substance of Ezetimibe, works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called "good" cholesterol because it helps keep the "bad" cholesterol from building up in the arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. This medicine is used for patients who cannot control their cholesterol levels by cholesterol-lowering diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Ezetimibe 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]) - together with a statin, when your cholesterol level is not well controlled with a statin alone - alone, when statin treatment is inappropriate or is not tolerated. Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetimibe 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient with known effect: Each tablet contains 63 mg of lactose monohydrate. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, capsule shaped tablets, 8 mm x 4 mm in size, debossed with “713” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Primary hypercholesterolaemia_ Ezetimibe, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone. Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated. _PREVENTION OF CARDIOVASCULAR EVENTS _ Ezetimibe is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin. _ _ _Homozygous Familial Hypercholesterolaemia (HoFH)_ Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe. Route of administration is oral. The recommended dose is one Ezetimibe 10 mg tablet daily. Ezetimibe can be administered at any time of the day, with or without food. When Ezetimibe is added to a statin, either the indicated usual initial dose of that particular statin or the already establis Прочитайте повний документ