País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
Imbat Limited
C01BD; C01BD01
AMIODARONE HYDROCHLORIDE
200 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Antiarrhythmics, class III; amiodarone
Authorised
2008-10-03
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE ® X 200MG TABLETS (amiodarone hydrochloride) Your medicine is available using the above name but will be referred to as ‘Cordarone X Tablets’ throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Cordarone X Tablets are and what they are used for 2. Before you take Cordarone X Tablets 3. How to take Cordarone X Tablets 4. Possible side effects 5. How to store Cordarone X Tablets 6. Contents of the pack and other information 1. WHAT CORDARONE X TABLETS ARE AND WHAT THEY ARE USED FOR Cordarone X Tablets contain a medicine called amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablets helps your heartbeat to return to normal. Cordarone X Tablets can be used to: Treat uneven heartbeats where other medicines either have not worked or cannot be used Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation’. Cordarone X Tablets are used only when other medicines cannot be used Treat fast heartbeats which may happen suddenly and may be uneven. Cordarone X Tablets are used only when other medicines cannot be used 2. BEFORE YOU TAKE CORDARONE X TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to: iodine amiodarone any of the ot Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amiodarone hydrochloride 200mg. Excipient: lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the United Kingdom (as Amiodarone Hydrochloride & Cordarone X)._ Round, white tablets with a breakline on one side and marked ‘200’ and a logo on the other. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA0540/142/002 5 PHARMACOLOGICAL PROPERTIES As per PA0540/142/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Maize starch Povidone Colloidal anhydrous silica Magnesium stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be 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 25°C. Store in the original package in order to protect from light. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _8_ _2_ _9_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Re-boxed cardboard outer containing blister strips. Pack size 28 Overlabelled outer carton containing blister strips. Pack si Llegiu el document complet