País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
PCO Manufacturing Ltd.
C01BD; C01BD01
AMIODARONE HYDROCHLORIDE
200 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Antiarrhythmics, class III; amiodarone
Authorised
2004-03-05
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE X ® 100 MG TABLETS CORDARONE X ® 200 MG TABLETS amiodarone hydrochloride 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. What you need to know 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 100mg or 200mg Tablets (called Cordarone X Tablets in this leaflet) 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. WHAT YOU NEED TO KNOW 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 Llegiu el document complet
Health Products Regulatory Authority 17 November 2019 CRN00975F Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amiodarone hydrochloride 200 mg. Excipient: Each tablet contains Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from theNetherlands, Czech Republic, and Hungary:_ Round, white tablet with a breakline, '200' and a logo on one side, plain on the other side. _Product imported from the UK:_ Round, white tablet with a breakline on one side, '200' and a logo on the other side. The breakline is only to facilitate breaking for ease of swallowing and not to be divided 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 of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 17 November 2019 CRN00975F Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Blisterpacks of 30 in a carton and 28 or 60 tablets in an overlabelled outer carton. Not all pack sizes may bemarketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/119/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 March Llegiu el document complet