Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Rowex Ltd
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
10mg/5 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Not marketed
2016-04-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DANCEX SR PLUS 5 MG/2.5 MG PROLONGED-RELEASE TABLETS DANCEX SR PLUS 10 MG/5 MG PROLONGED-RELEASE TABLETS DANCEX SR PLUS 20 MG/10 MG PROLONGED-RELEASE TABLETS DANCEX SR PLUS 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 Dancex SR Plus is and what it is used for 2. What you need to know before you take Dancex SR Plus 3. How to take Dancex SR Plus 4. Possible side effects 5. How to store Dancex SR Plus 6. Contents of the pack and other information 1. WHAT DANCEX SR PLUS IS AND WHAT IT IS USED FOR Dancex SR Plus is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours. These tablets are only for use in adults. PAIN RELIEF You have been prescribed Dancex SR Plus for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation. HOW THESE TABLETS WORK IN PAIN RELIEF Dancex SR Plus contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Dancex SR Plus, and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of Dancex SR Plus, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with Perskaitykite visą dokumentą
Health Products Regulatory Authority 27 June 2023 CRN00DNZN Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dancex SR Plus 10 mg/5 mg Prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9mg 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. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dancex SR Plus is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Analgesia_ The analgesic efficacy of Dancex SR Plus 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, Dancex SR Plus 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. Patients already receiving opioids may be started on higher doses of Dancex SR Plus depending on their previous opioid experience. Dancex SR Plus 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The maximum daily dose of Dancex SR Plus 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 and w Perskaitykite visą dokumentą