País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Simvastatin; Ezetimibe
PCO Manufacturing Ltd.
C10BA; C10BA02
Simvastatin; Ezetimibe
10 mg / 40 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe
2018-12-14
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INEGY ® 10 MG/40 MG TABLETS ezetimibe/simvastatin 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 INEGY is and what it is used for 2. What you need to know before you take INEGY 3. How to take INEGY 4. Possible side effects 5. How to store INEGY 6. Contents of the pack and other information 1. WHAT INEGY IS AND WHAT IT IS USED FOR 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. 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” chol Llegiu el document complet
Health Products Regulatory Authority 04 February 2021 CRN00C4TR Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Inegy 10 mg/40 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin. Excipient(s) with known effect Each 10 mg/40 mg tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Italy_ White to off-white capsule-shaped tablets with code '313' on one side. 4 CLINICAL PARTICULARS As per PA1286/062/003 5 PHARMACOLOGICAL PROPERTIES As per PA1286/062/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Butylated hydroxyanisole Citric acid monohydrate Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propyl gallate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister 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 and light. Health Products Regulatory Authority 04 February 2021 CRN00C4TR Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blisters of 30 tablets in an outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL 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 PPA0465/223/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 th December 2018 10 DATE OF REVISION OF THE TEXT February 2021 Llegiu el document complet