Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Atorvastatin calcium trihydrate
Actavis Group PTC ehf
C10AA; C10AA05
Atorvastatin calcium trihydrate
80 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; atorvastatin
Marketed
2012-09-07
ATORVASTATIN 10 MG, 20 MG, 40 MG & 80 MG FILM-COATED TABLETS Atorvastatin PACKAGE LEAFLET: INFORMATION FOR THE USER 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 ATORVASTATIN IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN 3 HOW TO TAKE ATORVASTATIN 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ATORVASTATIN 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN DO NOT TAKE ATORVASTATIN: • if you are allergic to Atorvastatin or any of the other ingredients of medicine (listed in section 6) • if you have or have ever had a disease which affects the liver • if you have had any unexplained abnormal blood tests for liver function • if you are a woman able to have children and not using reliable contraception • if you are pregnant or trying to become pregnant • if you are breast-feeding • if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C. WARNINGS AND PRE Read the complete document
HealthProductsRegulatoryAuthority 26September2019 CRN0091QN Page1of18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin80mgFilm-coatedTablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachfilm-coatedtabletcontains80 mgofatorvastatinasatorvastatincalciumtrihydrate. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. White,oval,biconvex,10x19mmfilm-coatedtabletsmarkedwith“80”ononesideand“A”ontheother. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatinisindicatedasanadjuncttodietforreductionofelevatedtotalcholesterol(total-C),LDL-cholesterol(LDL-C), apolipoproteinB,andtriglyceridesinadults,adolescentsandchildrenaged10yearsorolderwithprimary hypercholesterolaemiaincludingfamilialhypercholesterolaemia(heterozygousvariant)orcombined(mixed)hyperlipidaemia (correspondingtoTypesIIaandIIboftheFredricksonclassification)whenresponsetodietandothernonpharmacological measuresisinadequate. Atorvastatinisalsoindicatedtoreducetotal-CandLDL-Cinadultswithhomozygousfamilialhypercholesterolaemiaasan adjuncttootherlipid-loweringtreatments(e.g.LDLapheresis)orifsuchtreatmentsareunavailable. Prevention of cardiovascular disease Preventionofcardiovasculareventsinadultpatientsestimatedtohaveahighriskforafirstcardiovascularevent(seesection 5.1),asanadjuncttocorrectionofotherriskfactors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Thepatientshouldbeplacedonastandardcholesterol-loweringdietbefor Read the complete document