Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Fentanyl
Imbat Limited
N02AB; N02AB03
Fentanyl
25 micrograms/hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Authorised
2015-10-23
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DUROGESIC ® DTRANS ® 25 MICROGRAMS/HOUR TRANSDERMAL PATCH (fentanyl) Your medicine is available using the above name but will be referred to as Durogesic DTrans throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. This medicine has been prescribed for you (or your child) 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 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 DUROGESIC DTRANS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS 3. HOW TO USE DUROGESIC DTRANS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DUROGESIC DTRANS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR The name of your medicine is Durogesic DTrans. The patches help relieve pain that is very bad and long-lasting: in adults who need continuous pain treatment in children above 2 years of age who are already using opioid medication and who need continuous pain treatment. Durogesic DTrans contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS DO NOT USE DUROGESIC DTRANS IF: You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6) You have pain which lasts only for a short period, such as sudden pain or pain after having an operation You have breathing difficulties, with slow or shallow breathing Do not use this medicine if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before using Durogesic Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Durogesic DTrans 25 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Durogesic DTrans 25 patch contains fentanyl 4.2 mcg. Release rate of approximately 25 micrograms per hour; active surface area 10.5 cm 2 . For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patches _Product imported from Poland_ Translucent rectangular patch with rounded corners, marked with product name, strength and a border in red coloured ink. The patch has a sticky back so that it can be stuck onto the skin. Each patch is marked Durogesic® 25 µg fentanyl/h. 4 CLINICAL PARTICULARS As per PA 0748/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA 0748/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Polyacrylate adhesive Polyethylene terephthalate/ethyl vinyl acetate film Red printing ink Siliconised polyester film 6.2 INCOMPATIBILITIES To prevent interference with the adhesive properties of Durogesic DTrans, no creams, oils, lotions or powder should be applied to the skin area when the Durogesic DTrans transdermal patch is applied. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the patch pouch and outer carton of the product as marked in the country of origin 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any other special storage precautions. 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_ _ _ _0_ _8_ _/_ _0_ _9_ Aqra d-dokument sħiħ