Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Atorvastatin calcium trihydrate
Bluefish Pharmaceuticals AB
C10AA; C10AA05
Atorvastatin calcium trihydrate
40 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; atorvastatin
Marketed
2018-11-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN BLUEFISH 10 MG FILM-COATED TABLETS ATORVASTATIN BLUEFISH 20 MG FILM-COATED TABLETS ATORVASTATIN BLUEFISH 30 MG FILM-COATED TABLETS ATORVASTATIN BLUEFISH 40 MG FILM-COATED TABLETS ATORVASTATIN BLUEFISH 60 MG FILM-COATED TABLETS ATORVASTATIN BLUEFISH 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 BLUEFISH is and what it is used for 2. What you need to know before you take ATORVASTATIN BLUEFISH 3. How to take ATORVASTATIN BLUEFISH 4. Possible side effects 5. How to store ATORVASTATIN BLUEFISH 6. Contents of the pack and other information 1. WHAT ATORVASTATIN BLUEFISH IS AND WHAT IT IS USED FOR ATORVASTATIN BLUEFISH belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. ATORVASTATIN BLUEFISH 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 BLUEFISH 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 BLUEFISH DO NOT TAKE ATORVASTATIN BLUEFISH − if you are hypersensitive (allergic) to ATORVASTATIN or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine listed in section 6 Perskaitykite visą dokumentą
Health Products Regulatory Authority 21 June 2023 CRN00DHV6 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin Bluefish 40 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Atorvastatin Bluefish 40 mg film-coated tablets: Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: Each Atorvastatin Bluefish 40 mg film-coated tablet contains 215.20 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Atorvastatin Bluefish 40 mg film-coated tablets: white oblong film-coated tablets, embossed 40 on one side and 'ATV' on the other side and 13.3 mm; width: 6.7 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia ATORVASTATIN BLUEFISH 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 non-pharmacological measures is inadequate. ATORVASTATIN BLUEFISH 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 BLUEFISH and should continue on this diet during treatment with ATORVASTATIN BLUEFISH. The dose should Perskaitykite visą dokumentą