国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Rosuvastatin
Teva B.V.
C10AA; C10AA07
Rosuvastatin
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; rosuvastatin
Marketed
2015-11-06
Rosuvastatin, DK/H/2293/001-004/DC, 19.10.23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATIN TEVA PHARMA 5 MG FILM-COATED TABLETS ROSUVASTATIN TEVA PHARMA 10 MG FILM-COATED TABLETS ROSUVASTATIN TEVA PHARMA 20 MG FILM-COATED TABLETS ROSUVASTATIN TEVA PHARMA 40 MG FILM-COATED TABLETS rosuvastatin 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 Rosuvastatin Teva Pharma Teva Pharma is and what it is used for 2. What you need to know before you take Rosuvastatin Teva Pharma Teva Pharma 3. How to take Rosuvastatin Teva Pharma film-coated tablets 4. Possible side effects 5. How to store Rosuvastatin Teva Pharma film-coated tablets 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN TEVA PHARMA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Rosuvastatin Teva Pharma film-coated tablets belongs to a group of medicines called statins. YOU HAVE BEEN PRESCRIBED ROSUVASTATIN TEVA PHARMA FILM-COATED TABLETS BECAUSE: • You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Teva Pharma film-coated tablets is used in adults, adolescents and children 6 years or older to treat high cholesterol. You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin Teva Pharma film-coated tablets. Or • You have other factors that increase your risk of having a hear 完全なドキュメントを読む
Health Products Regulatory Authority 16 January 2024 CRN00DPZY Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin Teva Pharma 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains either 20 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: Each 20 mg film-coated tablet contains 190 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Rosuvastatin 20 mg film-coated tablets: round, biconvex, pink tablet, debossed with '20' on one side and with a score line on the other side, diameter: 9 mm. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HYPERCHOLESTEROLAEMIA Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Adults, adolescents and children aged 6 years or older with homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. PREVENTION OF CARDIOVASCULAR EVENTS Prevention of major cardiovascular events in patients who are 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 Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. _Rosuvastatin 5, 10, 20, 40 mg film-coated tablets _may be given at any time of day, with or without food. TREATMENT OF HYPERCHOLESTEROLAEMIA The recommended start dose is 5 mg or 10 mg ora 完全なドキュメントを読む