Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
Icosapent ethyl
Amarin Pharmaceuticals Ireland Limited
C10AX
icosapent ethyl
Lipid modifying agents
Dyslipidemias
Indicated to reduce cardiovascular risk as an adjunct to statin therapy.
Revision: 5
Authorised
2021-03-26
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VAZKEPA 998 MG S OFT CAPSULES icosapent ethyl This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vazkepa is and what it is used for 2. What you need to know before you take Vazkepa 3. How to take Vazkepa 4. Possible side effects 5. How to store Vazkepa 6. Contents of the pack and other information 1. WHAT VAZKEPA IS AND WHAT IT IS USED FOR Vazkepa contains the active substance icosapent ethyl, a highly purified omega-3 fatty acid from fish oil. Vazkepa lowers levels of triglycerides (types of fat) in the blood and it is used with a statin medicine (that lowers blood cholesterol) to prevent cardiovascular events, such as: - heart attack - stroke - death from heart or vascular disease Vazkepa is used in adults with high blood triglycerides who already have heart disease or have diabetes and other conditions that put them at a higher risk of cardiovascular events. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VAZKEPA _ _ DO NOT TAKE VAZKEPA - If you are ALLERGIC TO ICOSAPENT ETHYL , soya or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Vazkepa: - If you are ALLERGIC TO FISH OR TO SHELLFISH . - If you have PROBLEM Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Vazkepa 998 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 998 mg of icosapent ethyl. Excipients with known effect Each capsule contains 30 mg maltitol (E965 ii), 83 mg sorbitol (E420 ii) and soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule (capsule) Oblong soft capsule, 25 x 10 mm, printed with “IPE” in white ink, with a light yellow to amber shell containing a colourless to pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and • established cardiovascular disease, or • diabetes, and at least one other cardiovascular risk factor. For study details including cardiovascular risk factors and results with respect to effects on cardiovascular events see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended daily oral dose is 4 capsules taken as two 998 mg capsules twice daily. If a dose is missed, patients should take it as soon as they remember. However, if one daily dose is missed, the next dose should not be doubled. _Elderly (≥ 65 years) _ No dose adjustment is necessary based on age (see section 5.2). _Renal impairment _ No dose reduction is recommended (see also section 5.2). _ _ _Hepatic impairment _ 3 No dose reduction is recommended (see also sections 4.4 and 5.2). _Paediatric population _ There is no relevant use of icosapent ethyl in children aged <18 years of age in reducing the risk of cardiovascular events in statin-treated patients at high cardiov Preberite celoten dokument