Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fentanyl
Lavipharm S.A.
N02AB; N02AB03
Fentanyl
75 Microgram per hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Marketed
2012-01-06
PACKAGE LEAFLET: INFORMATION FOR THE USER FENTADUR 12 MICROGRAMS/HOUR TRANSDERMAL PATCH 25 MICROGRAMS/HOUR TRANSDERMAL PATCH 50 MICROGRAMS/HOUR TRANSDERMAL PATCH 75 MICROGRAMS/HOUR TRANSDERMAL PATCH 100 MICROGRAMS/HOUR TRANSDERMAL PATCH fentanyl 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 Fentadur is and what it is used for 2. What you need to know before you use Fentadur 3. How to use Fentadur 4. Possible side effects 5. How to store Fentadur 6. Contents of the pack and other information 1. WHAT FENTADUR IS AND WHAT IT IS USED FOR The name of your medicine is Fentadur. 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. Fentadur contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTADUR DO NOT USE FENTADUR IF: - You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6). - You suffer from 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 Fentadur. WARNINGS AND PRECAUTIONS PATCH STICKING TO ANOTHER PERSON The patch sho Read the complete document
Health Products Regulatory Authority 29 January 2024 CRN00DJRR Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fentadur 75 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fentadur 75 micrograms/ hour transdermal patch contains 8.25 mg of fentanyl in a patch size of 30 cm 2 , releasing 75 micrograms of fentanyl per hour. Excipients(s) with known effect: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Fentadur transdermal patch is rectangular with rounded corners and a two-colour printing on its backing. It is placed between two oversized, transparent protective layers which must be removed prior to the patch application. The patches are printed as follows: Beige diagonal stripes with repetitive "Fentanyl" in blue font alternating with blue diagonal stripes with repetitive "75 microg/h" in beige font. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS This product is indicated for management of severe chronic pain that requires continuous long term opioid administration. CHILDREN Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fentadurdoses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25, 50, 75 and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively. Initial dose selection The appropriate initiating dose of Fentadur should be based on the patient's current opioid use. It is recommended that Fentadur be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. ADULTS Opi Read the complete document