Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
FENTANYL CITRATE
Teva Pharma B.V.
N02AB; N02AB03
FENTANYL CITRATE
1600 microgram(s)
Lozenge
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Not marketed
2002-01-23
23 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR ACTIQ 400 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR ACTIQ 600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR ACTIQ 800 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR ACTIQ 1,200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR ACTIQ 1,600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ACTIQ is and what it is used for 2. What you need to know before you use ACTIQ 3. How to use ACTIQ 4. Possible side effects 5. How to store ACTIQ 6. Contents of the pack and other information 1. WHAT ACTIQ IS AND WHAT IT IS USED FOR ACTIQ contains the active substance fentanyl which is a strong pain-relieving medicine known as an opioid. The ACTIQ unit comes as a lozenge on a stick. • It is used to treat breakthrough pain in adults and adolescents aged 16 years and above with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain. Breakthrough pain is additional sudden pain that occurs suddenly in spite of your having taken your usual opioid pain-relieving medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIQ DO NOT USE ACTIQ: • if you are not regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular sc Aqra d-dokument sħiħ
Health Products Regulatory Authority 17 December 2018 CRN008KR0 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actiq 1600 micrograms compressed lozenge with integral oromucosal applicator. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One lozenge contains 1600 micrograms fentanyl (as citrate). Excipients(s) with known effect: Each lozenge contains dextrates (equivalent to approximately 2 grams of glucose), sucrose (approximately 30 milligrams confectioner’s sugar) and propylene glycol (part of the artificial berry flavour and imprinting ink) as excipients. _For the full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Compressed lozenge with integral oromucosal applicator. Actiq is formulated as a white to off-white compressed powder medicinal product matrix attached using edible glue to a fracture resistant radio opaque plastic applicator. The dosage strength is marked on the lozenge and on the plastic applicator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Actiq is indicated for the management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Health Products Regulatory Authority 17 December 2018 CRN008KR0 Page 2 of 19 In order to minimise the risks of opioid‑related adverse reactions and to identify the successful dose, it is imperative that patients be monitored closely by health professionals during the titration process. ACTIQ is not interchangeable on a mcg to mcg basis with other short‑acting fentanyl products that are indicat Aqra d-dokument sħiħ