Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Rosuvastatin calcium
Zentiva k.s.
C10AA07
Rosuvastatin calcium
Film-coated tablet
rosuvastatin
2022-06-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROSUVASTATIN ZENTIVA 5 MG FILM-COATED TABLETS ROSUVASTATIN ZENTIVA 10 MG FILM-COATED TABLETS ROSUVASTATIN ZENTIVA 20 MG FILM-COATED TABLETS ROSUVASTATIN ZENTIVA 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 Zentiva is and what it is used for 2. What you need to know before you take Rosuvastatin Zentiva 3. How to take Rosuvastatin Zentiva 4. Possible side effects 5. How to store Rosuvastatin Zentiva 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN ZENTIVA IS AND WHAT IT IS USED FOR The name of your medicine is Rosuvastatin Zentiva 5 mg, 10 mg, 20 mg or 40 mg film-coated Tablets (referred to as Rosuvastatin Zentiva throughout this leaflet). Rosuvastatin Zentiva belongs to a group of medicines called statins. You have been prescribed Rosuvastatin Zentiva because: • You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Zentiva 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 Zentiva. 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 Leggi il documento completo
Health Products Regulatory Authority 01 September 2023 CRN00DHXJ Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin Zentiva 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10.4 mg rosuvastatin calcium, equivalent to 10 mg rosuvastatin. Excipient with known effect Each film-coated tablet contains 57 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Light pink, film-coated, oval, biconvex tablet with score line on one side with length approx. 9 mm and width approx. 5 mm. The tablet can be divided into equal doses. 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. Posology _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 inhib Leggi il documento completo