Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Ezetimibe
PCO Manufacturing Ltd.
C10AX; C10AX09
Ezetimibe
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Other lipid modifying agents; ezetimibe
Authorised
2009-07-31
_ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZETROL ® 10MG TABLETS ezetimibe READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What EZETROL is and what it is used for 2. What you need to know before you take EZETROL 3. How to take EZETROL 4. Possible side effects 5. How to store EZETROL 6. Contents of the pack and other information 1. WHAT EZETROL IS AND WHAT IT IS USED FOR 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. 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 bad cholestero Pročitajte cijeli dokument
Health Products Regulatory Authority 15 July 2022 CRN00D0VQ Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetrol 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient(s) with known effect: Each tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Greece, the Czech Republic and Poland:_ White to off-white, capsule-shaped tablets debossed with '414' on one side. 4 CLINICAL PARTICULARS As per PA23198/023/001 5 PHARMACOLOGICAL PROPERTIES As per PA23198/023/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone (K29-32) Sodium laurilsulfate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Store in the original package in order to protect from moisture. Health Products Regulatory Authority 15 July 2022 CRN00D0VQ Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER 2 x blister strips containing 14 tablets contained in a carton or an over-labelled outer carton. Pack size: 28 tablets (sourced from the UK, Greece, Czech Republic & Poland) 3 x blister strips containing 10 tablets or 2 x blisters containing 15 tablets contained in a carton and an over-labelled carton. Pack size: 30 tablets (sourced from Greece & The Czech Republic). Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/227/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 st July 2009 10 DATE OF REVISIO Pročitajte cijeli dokument