Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Atorvastatin
Rowex Ltd
C10AA; C10AA05
Atorvastatin
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; atorvastatin
Not marketed
2010-09-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVAS 10 MG FILM-COATED TABLETS ATORVAS 20 MG FILM-COATED TABLETS ATORVAS 40 MG FILM-COATED TABLETS ATORVAS 80 MG FILM-COATED TABLETS 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 Atorvas is and what it is used for 2. What you need to know before you take Atorvas 3. How to take Atorvas 4. Possible side effects 5 How to store Atorvas 6. Contents of the pack and other information 1. WHAT ATORVAS IS AND WHAT IT IS USED FOR Atorvas belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvas is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and lifestyle changes on their own have failed. If you are at an increased risk of heart disease, Atorvas 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 ATORVAS DO NOT TAKE ATORVAS: − if you are allergic to atorvastatin or any of the other ingredients of this 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 Preberite celoten dokument
Health Products Regulatory Authority 02 January 2024 CRN00F15F Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvas 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablets contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate) Excipient with known effect Each film-coated tablet contains 25.9 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex film-coated tablet with debossment "A10" on one side, plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypercholesterolaemia_ Atorvas is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvas is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of cardiovascular disease_ Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors_._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvas and should continue on this diet during treatment with Atorvas. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. The usual starting dose is 10 mg once a day. Adjustment of dose should be made at inter Preberite celoten dokument