البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Fentanyl
Teva Pharma B.V.
N02AB; N02AB03
Fentanyl
600 microgram(s)
Compressed lozenge
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Marketed
2002-01-23
2 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 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 schedule, for at least a week, to control your persistent pain. If you have not been using these medicines you MUST NOT use ACTIQ, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even st اقرأ الوثيقة كاملة
Health Products Regulatory Authority 09 October 2023 CRN00DJ1Q Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actiq 600 micrograms compressed lozenge with integral oromucosal applicator 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One lozenge contains 600 micrograms fentanyl (as citrate). Excipient with known effect: One lozenge contains approximately 1.89 g glucose and 20-36 mg sucrose. 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 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 indicated for the use of breakthrough cancer pain, as the pharmacokinetic profiles and/or dosing schedules of these products are significantly different. Patients should be instructed not to use more than one short‑acting fentanyl product concurrently for t اقرأ الوثيقة كاملة