País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ROSUVASTATIN CALCIUM
Accord Healthcare Limited
C10AA07
ROSUVASTATIN CALCIUM
40 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
rosuvastatin
Not Marketed
2015-08-28
PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATIN 5 MG FILM-COATED TABLETS ROSUVASTATIN 10 MG FILM-COATED TABLETS ROSUVASTATIN 20 MG FILM-COATED TABLETS ROSUVASTATIN 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 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rosuvastatin tablet is and what it is used for 2. What you need to know before you take Rosuvastatin tablets 3. How to take Rosuvastatin tablets 4. Possible side effects 5. How to store Rosuvastatin tablets 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN TABLET IS AND WHAT IT IS USED FOR Rosuvastatin tablets belong to a group of medicines called statins. You have been prescribed Rosuvastatin tablets because: • You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin 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 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 tablets . 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 deposits in your arteries. WHY IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN TABLETS? Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipient(s) with known effect: Lactose: Each 40 mg film-coated tablet contains 164mg lactose. Allura red AC: Each 40 mg film-coated tablet contains 0.034 mg allura red AC. Sunset yellow: Each 40 mg film-coated tablet contains 0.04 mg sunset yellow. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, oval, approximately 11.5 mm in length and 6.9 mm in width, biconvex, film-coated tablet, debossed “40” on one side and “R” 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. 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 Posology 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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Llegiu el document complet