देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
OMEGA-3-ACID ETHYL ESTERS 90
Epax AS
OMEGA-3-ACID ETHYL ESTERS 90
1000 Milligram
Capsules, Soft
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER OMEGA-3-ACID ETHYL ESTERS LOMEGAR 1000MG CAPSULES, SOFT Omega-3-acid ethyl esters 90 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft are and what it is used for 2. What you need to know before you take Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft 3. How to take Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft 4. Possible side effects 5. How to store Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft 6. Contents of the pack and other information 1. WHAT OMEGA-3-ACID ETHYL ESTERS LOMEGAR 1000MG CAPSULES, SOFT IS AND WHAT IT IS USED FOR Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft contains highly purified omega-3 polyunsaturated fatty acids. Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft belong to a group of medicines called reducers of cholesterol and triglycerides. Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft is used: • together with other medicines for treatment after a heart attack. • to treat certain forms of increased triglycerides (fats) in the bloo पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omega-3-acid ethyl esters Lomegar 1000mg Capsules, Soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 1000mg of omega-3-acid-ethyl-esters 90, comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460 mg) and docosahexaenoic acid (DHA) ethyl ester (380 mg). Excipient with known effect: lecithin (soya). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Soft, oblong, transparent gelatin capsules containing pale yellow oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Post Myocardial Infarction Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet medicinal products, betablockers, ACE inhibitors). Hypertriglyceridaemia Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response: - type IV in monotherapy, - type IIb/III in combination with statins, when control of triglycerides through statins alone is insufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population_ There are no data available regarding the use of omega-3-acid ethyl esters in children and adolescents. _Special populations_ There are no data available regarding the use of omega-3-acid ethyl esters in elderly patients over 70 years of age, or in patients with hepatic impairment (see section 4.4), and only limited information regarding the use in patients with renal impairment. Method of administration _Adults and elderly below 70 years of age_ Post Myocardial Infarction One capsule daily HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ पूरा दस्तावेज़ पढ़ें