Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Ezetimibe; Atorvastatin
PCO Manufacturing Ltd.
C10BA; C10BA05
Ezetimibe; Atorvastatin
10/40 mg/mg
Film-coated tablet
HMG CoA reductase inhibitors in combination with other lipid modifying agents; atorvastatin and ezetimibe
2021-04-23
PACKAGE LEAFLET: INFORMATION FOR THE USER ATOZET ® 10 MG/10 MG FILM-COATED TABLETS ATOZET ® 10 MG/20 MG FILM-COATED TABLETS ATOZET ® 10 MG/40 MG FILM-COATED TABLETS ATOZET ® 10 MG/80 MG FILM-COATED TABLETS EZETIMIBE/ATORVASTATIN 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 ATOZET is and what it is used for 2. What you need to know before you take ATOZET 3. How to take ATOZET 4. Possible side effects 5. How to store ATOZET 6. Contents of the pack and other information 1. WHAT ATOZET IS AND WHAT IT IS USED FOR 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. 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 Lire le document complet
Health Products Regulatory Authority 04 October 2023 CRN00DV1D Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atozet 10 mg/40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. _Product imported from the Czech Republic and France:_ Capsule-shaped, biconvex, white to off-white, film coated, size 16.38 mm x 6.27 mm, "337" debossed on one side. 4 CLINICAL PARTICULARS As per PA23198/022/003 5 PHARMACOLOGICAL PROPERTIES As per PA23198/022/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core Ezetimibe Layer Croscarmellose sodium Lactose monohydrate Magnesium stearate Cellulose, microcrystalline Povidone Sodium laurilsulfate Atorvastatin Layer Cellulose, microcrystalline Lactose monohydrate Hydroxypropylcellulose Croscarmellose sodium Polysorbate 80 Calcium carbonate Magnesium stearate Silica, colloidal anhydrous Film coating Hypromellose Macrogol 8000 Titanium dioxide (E171) Talc Health Products Regulatory Authority 04 October 2023 CRN00DV1D Page 2 of 2 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be 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 Store in the original package in order to protect from oxygen. 6.5 NATURE AND CONTENTS OF CONTAINER Packs of 30 film-coated tablets in aluminium blisters. 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 PPA0465/470/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Dat of first authorisation: 23 rd April 2021 10 DATE OF REV Lire le document complet