Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluvastatin sodium
Aspire Pharma Ltd
C10AA04
Fluvastatin sodium
80mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060209730066
PACKAGE LEAFLET: INFORMATION FOR THE USER DORISIN XL 80MG PROLONGED RELEASE TABLETS Fluvastatin 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 Dorisin XL is and what it is used for 2. Before you take Dorisin XL 3. How to take Dorisin XL 4. Possible side effects 5. How to store Dorisin XL 6. Contents of the pack and other information 1. WHAT DORISIN XL IS AND WHAT IT IS USED FOR Dorisin XL contains the active substance fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone. • Dorisin XL is a medicine used to TREAT RAISED LEVELS OF FATS IN THE BLOOD IN ADULTS, in particular total cholesterol and so called “bad” or LDL cholesterol, which is associated with an increased risk of heart disease and stroke. • in adult patients with high blood levels of cholesterol. • in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid). • Your doctor can also prescribe Dorisin XL to prevent further serious cardiac events (e.g. heart attack) in patients who have already had a heart catheterisation, with an intervention in the heart vessel. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DORISIN XL DO NOT TAKE DORISIN XL • If you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6). • If you currently have liver problems or i Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dorisin XL 80mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet of Dorisin XL contains 84.2mg fluvastatin sodium equivalent to 80mg fluvastatin free acid. Excipient with known effect Each prolonged-release tablet contains 0.19 mmol (4.47 mg) sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Dorisin XL tablets are dark yellow, round, biconvex tablets. 10.1mm ± 0.1mm in diameter and 3.7mm ± 0.2mm in thickness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dyslipidaemia Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ Dyslipidaemia Prior to initiating treatment with fluvastatin, patients should be placed on a standard cholesterollowering diet, which should be continued during treatment. Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished. The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of <25% a starting dose of 20 mg fluvastatin may be used in the evening. For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 40 mg Fluvastatin in the evening. The dose may be uptitrated to 80 mg daily, administered as a single dose (one Dorisin XL tablet) at any time of the day or as one 40 mg dose of Fluvastatin given twice daily (one dose in the morning and one dose in the evening). The maximum lipid-lowering effect with a given dose is achieved within 4 weeks. Belgenin tamamını okuyun