País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
PCO Manufacturing
C01EB15
TRIMETAZIDINE DIHYDROCHLORIDE
20 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other cardiac preparations
Authorised
2005-02-04
PACKAGE LEAFLET: INFORMATION FOR THE USER VASTAREL ® 20MG FILM-COATED TABLETS Trimetazidine dihydrochloride ▼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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Vastarel 20mg is and what it is used for 2. What you need to know before you take Vastarel 20mg 3. How to take Vastarel 20mg 4. Possible side effects 5. How to store Vastarel 20mg 6. Contents of the pack and other information 1. WHAT VASTAREL 20MG IS AND WHAT IT IS USED FOR This medicine is intended for use in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease). It protects the heart cells from the effects of a reduced oxygen supply during an episode of angina. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VASTAREL 20 MG DO NOT TAKE VASTAREL 20MG If you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6) If you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture, slow movements and a shuffling, unbalanced walk) If you ha Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 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 Vastarel 20mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg trimetazidine dihydrochloride. Excipients with known effect: Ponceau 4R (E124) and sunset yellow (E110) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Greece_ Round, red film-coated tablets. 4 CLINICAL PARTICULARS As per PA0068/010/001 5 PHARMACOLOGICAL PROPERTIES As per PA0068/010/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core:_ Maize Starch Mannitol Povidone Magnesium stearate Talc _Film coating:_ Glycerol Hypromellose Macrogol 6000 Magnesium stearate Ponceau 4R aluminium lake (E124) Sunset yellow FCF aluminium lake (E110) Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/04/2016_ _CRN 2175323_ _page number: 1_ 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30° C. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 60 tablets in a cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBE Leia o documento completo