מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Rosuvastatin zinc; Ezetimibe
EGIS Pharmaceuticals PLC
C10BA06
Rosuvastatin zinc; Ezetimibe
40 /10 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
rosuvastatin and ezetimibe
Marketed
2014-08-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIPOCOMB 40 MG/10 MG HARD CAPSULES rosuvastatin and ezetimibe 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 Lipocomb is and what it is used for 2. What you need to know before you take Lipocomb 3. How to take Lipocomb 4. Possible side effects 5. How to store Lipocomb 6. Contents of the pack and other information 1. WHAT LIPOCOMB IS AND WHAT IT IS USED FOR Lipocomb contains two different active substances in one capsule. One of the active substances is rosuvastatin, belonging to the group of so-called statins, the other active substance is ezetimibe. Lipocomb is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine works to reduce your cholesterol in two ways: it reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. _ _ For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or re קרא את המסמך השלם
Health Products Regulatory Authority 22 January 2024 CRN00F2F2 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipocomb 40 mg/10 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of rosuvastatin (as rosuvastatin zinc) and 10 mg of ezetimibe. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule with red coloured cap and yellow coloured body filled with three tablets: one piece of white or almost white round, flat and bevel-edged Ezetimibe 10 mg tablet with a stylized E sign on one side of the tablet and 612 code on the other side; two pieces of white or almost white round Rosuvastatin 20 mg tablet with mark on one side of the tablet and no mark on the other side. The length of the capsule is about 21.7 mm (± 0.5 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Primary hypercholesterolemia:_ Lipocomb is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. _ _ _Prevention of cardiovascular events:_ Lipocomb is indicated as substitution treatment in adult patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), who are adequately controlled with the individual substances administered simultaneously at the same dose level as in the fixed combination medicinal products, but as separate products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lipocomb is indicated in adult patients adequately controlled with separately administered monocomponent preparations of the same doses as the recommended combination. The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Lipocomb. The recommended daily dose is one capsuleof the given strength קרא את המסמך השלם