Country: Malta
Language: English
Source: Medicines Authority
OMEGA, ACID ETHYL, ESTERS
BASF AS P.O.Box 420, N-1327 Lysaker, Norway
C10AX06
OMEGA-3-ACID ETHYL ESTERS 90 1000 mg
SOFT CAPSULE
OMEGA-3-ACID ETHYL ESTERS 90 1000 mg
POM
LIPID MODIFYING AGENTS
Authorised
2006-02-07
PACKAGE LEAFLET: INFORMATION FOR THE USER OMACOR 1000 MG SOFT CAPSULES 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 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. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET: 1. WHAT OMACOR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR 3. HOW TO TAKE OMACOR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE OMACOR 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT OMACOR IS AND WHAT IT IS USED FOR Omacor contains highly purified omega-3 polyunsaturated fatty acids. Omacor belongs to a group of so called reducers of cholesterol and triglycerides. _ _ Omacor is used: • to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR DO NOT TAKE OMACOR: • If you are allergic (hypersensitive) to the active substances or any of the other ingredients of OMACOR (listed in Section 6: Contents of the pack and other information) If any of the above applies to you, do not take this medicine, and talk to your doctor. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING OMACOR. • if you are due to have or have had surgery recently • if you have had a trauma recently • if you have a kidney problem • if you have diabetes which is not controlled • if you have problems with your liver. Your doctor will monitor any effects Omacor may have on your liver with blood tests. • if you are allergic to fish • if you have, or have had, heart problems • if you develop light-headedness, asthenia (feeling Read the complete document
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Omacor 1000 mg, capsules, soft _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _ONE CAPSULE CONTAINS _ Omega-3-acid ethyl esters 90 .................................................................................. 1000 mg comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg), including also as antioxidant 4 mg d-alpha-tocopherol (mixed with a vegetable oil e.g. soya oil). For a 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 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 is insufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hypertriglyceridaemia Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily. The capsules may be taken with food to avoid gastrointestinal disturbances. There is limited clinical data regarding the use of Omacor in elderly patients over 70 years of age and patients with renal impairment (see section 4.4). There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1._ _ Page 2 of 5 Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Systematic reviews and meta-analyses of randomized controlled clinical trials highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or ca Read the complete document