Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Fentanyl
Rowex Ltd
N02AB; N02AB03
Fentanyl
37.5 Microgram per hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Not marketed
2008-11-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FETANEX 12.5 MICROGRAM/HOUR TRANSDERMAL PATCH FETANEX 37.5 MICROGRAM/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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fetanex is and what it is used for 2. What you need to know before you use Fetanex 3. How to use Fetanex 4. Possible side effects 5. How to store Fetanex 6. Contents of the pack and other information 1. WHAT FETANEX IS AND WHAT IT IS USED FOR The name of your medicine is Fetanex. 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 medicines and who need continuous pain treatment. Fetanex contains an active substance called fentanyl. It belongs to a group of strong painkillers called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FETANEX DO NOT USE FETANEX 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 Fetanex. WARNINGS AND PRECAUTIONS • Fetanex can have life-threatening side effects in people who are not already regularly using prescribed opioid medicines. • Fetanex is a medicine t Lue koko asiakirja
Health Products Regulatory Authority 12 June 2019 CRN0093F5 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fetanex 37.5 microgram/hour Transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 37.5 micrograms fentanyl per hour. Each patch of 15.75 cm² contains 6.3 mg fentanyl. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch Transparent rounded oblong transdermal patch with imprint on the backing film: "fentanyl 37.5 µg/h" The patch consists of a release liner (to be removed prior to application of the patch) and two functional layers: one self-adhesive matrix layer containing fentanyl and a backing film impermeable to water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Fetanex 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 from 2 years of age who are receiving opioid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses of fentanyl transdermal patches 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 12.5, 25, 37.5, 50, 75 and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 0.9, 1.2, 1.8 and 2.4 mg per day, respectively. _Initial dose selection_ The appropriate initiating dose of fentanyl patches should be based on the patient's current opioid use. It is recommended that fentanyl patches 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 _Opioid-tolerant patients_ To convert opioid-tolerant patients from oral or parenteral opioids to Fetanex refer to equianalgesic po Lue koko asiakirja