Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
ROSUVASTATIN (AS CALCIUM)
Momaja s.r.o
C10AA07
ROSUVASTATIN (AS CALCIUM)
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors
Authorised
2016-03-11
PACKAGE LEAET: INFORMATION FOR THE USER ROSUVASTATIN MOMAJA 5 MG LM-COATED TABLETS ROSUVASTATIN MOMAJA 10 MG LM-COATED TABLETS ROSUVASTATIN MOMAJA 20 MG LM-COATED TABLETS ROSUVASTATIN MOMAJA 40 MG LM-COATED TABLETS Rosuvastatin READ ALL OF THIS LEAET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaet. 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 leaet. See section 4. WHAT IS IN THIS LEAET 1) What Rosuvastatin Momaja is and what it is used for 2) What you need to know before you take Rosuvastatin Momaja 3) How to take Rosuvastatin Momaja 4) Possible side effects 5) How to store Rosuvastatin Momaja 6) Contents of the pack and other information 1. WHAT ROSUVASTATIN MOMAJA IS AND WHAT IT IS USED FOR Rosuvastatin Momaja belongs to a group of medicines called statins. You have been prescribed Rosuvastatin Momaja because: - You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Momaja 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 taking 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 Momaja. 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 caused by a disease called atherosclerosis. Atherosclerosis is due to build-up of fatty de Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin Momaja 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Excipient(s) with known effect: Each film-coated tablet contains 85.1 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, round, biconvex, coated tablets of approximately 7.1 mm in diameter, debossed with ‘5’ on one side and ‘B’ on other side. 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. 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 Momaja may be given at any time of day, with or without food. TREATMENT OF HYPERCHOLESTEROLAEMIA The recommended start dose is 5 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 level and future cardiovascular risk as wel Preberite celoten dokument