Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Acino AG
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
40 / 20 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Not marketed
2016-05-20
Var. SE/H/1510/001-004/IB/008 changes without in green Var. SE/H/1510/001/IB/009 changes are marked in yellow PACKAGE LEAFLET: INFORMATION FOR THE USER EPETHINAN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS EPETHINAN 10 MG/5 MG PROLONGED-RELEASE TABLETS EPETHINAN 20 MG/10 MG PROLONGED-RELEASE TABLETS EPETHINAN 40 MG/20 MG PROLONGED-RELEASE TABLETS oxycodone hydrochloride / naloxone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Epethinan is and what it is used for 2. What you need to know before you take Epethinan 3. How to take Epethinan 4. Possible side effects 5. How to store Epethinan 6. Contents of the pack and other information 1. WHAT EPETHINAN IS AND WHAT IT IS USED FOR Epethinan is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours. PAIN RELIEF You have been prescribed Epethinan for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract constipation. How Epethinan works in pain relief Epethinan tablets contain oxycodone and naloxone as active substances. Oxycodone is responsible for the pain relieving effect of Epethinan. It is a strong analgesic (“painkiller”) that belongs to a group of medicines called opioids. Naloxone is intended to counteract constipation. Constipation is a typical side effect of treatment with opioid painkillers. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPETHINAN DO NOT TAKE EPETHINAN TABLETS if y Прочитайте повний документ
Health Products Regulatory Authority 19 January 2021 CRN00C459 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epethinan 40 mg/20 mg prolonged release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36.0 mg oxycodone and naloxone hydrochloride dihydrate equivalent to 20.0 mg naloxone hydrochloride and 18.0 mg naloxane. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Light orange to ochre, oval, convex, film-coated tablets with a nominal length of 13.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Epethinan is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Analgesia The analgesic efficacy of Epethinan is equivalent to oxycodone hydrochloride prolonged-release formulations. The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, Epethinan should be administered as follows: _Adults_ The usual starting dose for an opioid naïve patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals. Patients already receiving opioids may be started on higher doses of Epethinan depending on their previous opioid experience. Epethinan 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The maximum daily dose of Epethinan is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. The maximum daily dose is reserved for patients who have previously been maintained on a stable daily dose of oxycodone/naloxone and who have become in need of an increased dose. Special attention should be given to patients with compromised renal function and Прочитайте повний документ