Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
KRKA, d.d., Novo mesto
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
20mg/10 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Not marketed
2017-05-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NOLXADO 10 MG/5 MG PROLONGED-RELEASE TABLETS NOLXADO 20 MG/10 MG PROLONGED-RELEASE TABLETS NOLXADO 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 Nolxado is and what it is used for 2. What you need to know before you take Nolxado 3. How to take Nolxado 4. Possible side effects 5. How to store Nolxado 6. Contents of the pack and other information 1. WHAT NOLXADO IS AND WHAT IT IS USED FOR Nolxado 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 Nolxado _ _ tablets _ _ for the treatment of severe pain, which can be adequately managed only with opioid analgesics. HOW NOLXADO WORK IN PAIN RELIEF Nolxado contain oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the painkilling effect of Nolxado, and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of Nolxado , naloxone hydrochloride is intended to bring relief from some side effects of treatment with opioid painkillers. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOLXADO DO NOT TAKE NOLXADO - if you are allergic to oxycodone hydrochloride, or naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6); - if your brea Đọc toàn bộ tài liệu
Health Products Regulatory Authority 03 August 2022 CRN00CVVV Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nolxado 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 naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone. Excipient with known effect: lactose monohydrate Each 20 mg/10 mg prolonged-release tablet contains 51.78 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Light pink, oval, slightly biconvex, film coated tablets prolonged-release engraved with “20” on one side of the tablet (dimensions: 9.5 mm x 4.5 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 bring relief from some side effects of oxycodone. Nolxado is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Analgesia The analgesic efficacy of Nolxado 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, Nolxado 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. Patients already receiving opioids may be started on higher doses depending on their previous opioid experience. The maximum daily dose 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 who have become in need of an increased Đọc toàn bộ tài liệu