Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Atorvastatin calcium trihydrate
Laboratorios LICONSA, S.A.
C10AA05
Atorvastatin calcium trihydrate
Film-coated tablet
atorvastatin
Not marketed
2022-10-28
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN LICONSA 10 MG FILM-COATED TABLETS ATORVASTATIN LICONSA 20 MG FILM-COATED TABLETS ATORVASTATIN LICONSA 40 MG FILM-COATED TABLETS ATORVASTATIN LICONSA 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, 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 Liconsa is and what it is used for 2. What you need to know before you take Atorvastatin Liconsa 3. How to take Atorvastatin Liconsa 4. Possible side effects 5. How to store Atorvastatin Liconsa 6. Contents of the pack and other information 1. WHAT ATORVASTATIN LICONSA IS AND WHAT IT IS USED FOR Atorvastatin Liconsa belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Liconsa 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 Liconsa 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 LICONSA DO NOT TAKE ATORVASTATIN LICONSA − 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 abl Citiți documentul complet
Health Products Regulatory Authority 11 May 2023 CRN00DGF4 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin Liconsa 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: Each film-coated tablet contains 96.45 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex film coated tablets with bisection line on one side and debossed 20 on other side. Diameter 9.0 ± 0.2 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin Liconsa 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 Liconsa 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 Liconsa and should continue on this diet during treatment with Atorvastatin Liconsa . The dose should be individualised according to baseline LDL-C levels, the goal of therapy, Citiți documentul complet