Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
McDermott Laboratories Ltd., T/A Gerard Laboratories
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
10 mg/ 5 milligram(s)
Prolonged-release tablet
Natural opium alkaloids; oxycodone, combinations
Not marketed
2017-11-17
PACKAGE LEAFLET: INFORMATION FOR THE USER OXYARGIN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS OXYARGIN 10 MG/5 MG PROLONGED-RELEASE TABLETS OXYARGIN 20 MG/10 MG PROLONGED-RELEASE TABLETS OXYARGIN 30 MG/15 MG PROLONGED-RELEASE TABLETS OXYARGIN 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 Oxyargin is and what it is used for 2. What you need to know before you take Oxyargin 3. How to take Oxyargin 4. Possible side effects 5. How to store Oxyargin 6. Contents of the pack and other information 1. WHAT OXYARGIN IS AND WHAT IT IS USED FOR You have been prescribed Oxyargin for the symptomatic treatment of severe pain, which can be adequately managed only with opioid analgesics. How Oxyargin relieves pain Oxyargin contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Oxyargin,and is a potent analgesic (“painkiller”) of the opioid group. Restless Legs Syndrome You have been prescribed Oxyargin as a secondary treatment for severe to very severe restless legs syndrome that cannot be treated adequately with dopaminergic medication. Patients with restless legs syndrome have unpleasant sensations in the legs, and more rarely also in the arms. These sensations start as soon as the person rests, for example when sitting or lying down, and can only be relieved through the irresistible urge to move the legs and sometimes also th Baca dokumen lengkap
Health Products Regulatory Authority 20 January 2020 CRN009DCW Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxyargin 10 mg/5 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Pink, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 10.2 mm, a width of 4.7 mm and a height of 3.0 - 4.0 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. Second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Oxyargin is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ANALGESIA The analgesic efficacy of Oxyargin is equivalent to oxycodone hydrochloride prolonged-release formulations. The dose should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, Oxyargin should be administered as follows: _Adults _ The usual starting dose for opioid naive patients 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 Oxyargin depending on their previous opioid experience. Oxyargin 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The maximum daily dose of Oxyargin is 160 mg oxycodone hydrochloride and 840 mg naloxone hydrochloride. The ma Baca dokumen lengkap