Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
Mundipharma Pharmaceuticals Limited
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
20/10 mg/mg
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Not marketed
2018-03-05
30 PACKAGE LEAFLET: INFORMATION FOR THE USER5 MG/2.5 MG PROLONGED-RELEASE TABLETS Perskaitykite visą dokumentą10 MG/5 MG PROLONGED-RELEASE TABLETS 20 MG/10 MG PROLONGED-RELEASE TABLETS 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 is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains oxycodone hydrochloride and naloxone hydrochloride as active substances. is only for use in adults. Pain relief is used for the treatment of severe pain, which can be adequately managed only with opioid analgesics How works in pain relief Oxycodone hydrochloride is responsible for the pain-killing effect of , and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of , naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers. Restless legs syndrome is used for the second line symptomatic treatment of severe to very severe restless legs syndrome in people who can’t be treated with dopamine medicines. People
Health Products Regulatory Authority 15 October 2019 CRN009DJR Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Armoneve 20 mg/10 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged‑release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18 mg oxycodone and 10 mg naloxone hydrochloride as 10.9 mg of naloxone hydrochloride dihydrate equivalent to 9 mg naloxone. Excipient with known effect: Each prolonged‑release tablet contains 54.5 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged‑release tablet Pink, capsule shaped tablets, with a nominal length of 9.5 mm and with a film coating, embossed “OXN” on one side and “20” on the other side. 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. Armoneve is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Analgesia The analgesic efficacy of Armoneve 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. Armoneve should be administered as follows: _Adults_ The usual starting dose for an opioid naive patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals. Lower strengths are available to facilitate dose titration when initiating opioid therapy and for individual dose adjustment. Health Products Regulatory Authority 15 October 2019 CRN009DJR Page 2 of 15 Patients already receiving opioids may be started on higher doses depending on their previous opioid experience. The maximu Perskaitykite visą dokumentą