Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Rosuvastatin (as calcium)
NewLine Pharma S.L.
C10AA; C10AA07
Rosuvastatin (as calcium)
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; rosuvastatin
Not marketed
2017-06-09
ROSUVASTATIN 5 MG, 10 MG, 20 MG, 40 MG FILM-COATED TABLET 1.3.1 SMPC, LABELLING AND PACKAGE LEAFLET Version no. 1.3 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT5 MG FILM-COATED TABLETS Izlasiet visu dokumentu10 MG FILM-COATED TABLETS 20 MG FILM-COATED TABLETS 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 is and what it is used for 2) What you need to know before you take > 3) How to take 4) Possible side effects 5) How to store 6) Contents of the pack and other information 1) WHAT IS AND WHAT IT IS USED FOR belongs to a group of medicines called statins. YOU HAVE BEEN PRESCRIBED BECAUSE: You have a high cholesterol level. This means you are at risk from a heart attack or stroke. is used in adults, adolescents and children 6 years or older to treat high cholesterol ROSUVASTATIN 5 MG, 10 MG, 20 MG, 40 MG FILM-COATED TABLET 1.3.1 SMPC, LABELLING AND PACKAGE LEAFLET Version no. 1.3 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 . Or You have other factors that increase your risk of having a heart attack, stroke or related health problems. Heart attack, stroke and other problems can be c
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium). Excipient with known effect: lactose monohydrate. Each 20 mg film-coated tablet contains 193.57 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘20’ on one side and nothing on the other, with diameter 9 mm. 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. TREATMENT OF HYPERCHOLESTEROLAEMIA The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol H E A L T H P R O D U C T S R E G U L A Izlasiet visu dokumentu