Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
HCS bvba
OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
40mg/20 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
02AA55
Authorised
2017-05-19
ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. ERROR! UNKNOWN DOCUMENT PROPERTY NAME. – Updated: ERROR! UNKNOWN DOCUMENT PROPERTY NAME. Page 1 of 11 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 PAIN RELIEF You have been prescribed _NOLXADO _for the treatment of severe pain, which can be adequately managed only with opioid analgesics. HOW _NOLXADO_ WORK IN PAIN RELIEF _NOLXADO _contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone is responsible for the painkilling effect of _NOLXADO_. It is a strong analgesic (‘painkiller’) that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from some side effects of treatment with strong painkillers. 2. WHAT YOU N Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nolxado 40 mg/20 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36 mg oxycodone and 20 mg naloxone hydrochloride as 21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone. Excipient with known effect: lactose monohydrate Each 40 mg/20 mg prolonged-release tablet contains 103.55 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Brownish yellow, capsule shaped, slightly biconvex, film coated prolonged-release tablets engraved with “40” on one side of the tablet (dimensions: 14.0 mm x 6.0 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 of Nolxado depending on their previous opioid experience. The maximum daily dose of Nolxado is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. The H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Διαβάστε το πλήρες έγγραφο