Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Atorvastatin calcium trihydrate
Dexcel Pharma GmbH
C10AA; C10AA05
Atorvastatin calcium trihydrate
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; atorvastatin
Not marketed
2011-12-05
Atorvastatin Tablets 1.3: Product information 1.3.1 Package leaflet Page 1 of 7 [LOGO: DEXCEL® PHARMA GMBH] PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN 40 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, pharmacist or nurse. − 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atorvastatin Tablets are and what they are used for 2. What you need to know before you take Atorvastatin Tablets 3. How to take Atorvastatin Tablets 4. Possible side effects 5. How to store Atorvastatin Tablets 6. Contents of the pack and other information 1. WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR Atorvastatin Tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Tablets are 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, Atorvastatin Tablets 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 TABLETS DO NOT TAKE ATORVASTATIN TABLETS: • 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 fun Прочитайте повний документ
Health Products Regulatory Authority 09 May 2023 CRN00DGRP Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each film-coated tablet contains approximately 26 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, film coated tablet, embossed “10” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin 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. Atorvastatin 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 Atorvastatin and should continue on this diet during treatment with Atorvastatin. 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 intervals of 4 weeks or more. The maximum dose Прочитайте повний документ