Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Rowex Ltd
N02AA; N02AA05
OXYCODONE HYDROCHLORIDE
10 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone
Not marketed
2009-01-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXYDON 10 MG PROLONGED-RELEASE TABLETS oxycodone 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 Oxydon is and what it is used for 2. What you need to know before you take Oxydon 3. How to take Oxydon 4. Possible side effects 5. How to store Oxydon 6. Contents of the pack and other information 1. WHAT OXYDON IS AND WHAT IT IS USED FOR Oxydon contains the active substance oxycodone hydrochloride which is a centrally acting, strong painkiller of the group of opioids. Oxydon is used in adults and adolescents aged 12 years and older to treat severe pain, which can be adequately managed only with opioid analgesics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYDON DO NOT TAKE OXYDON IF YOU are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6) have breathing problems, such as severely depressed breathing (respiratory depression), severe chronic obstructive lung disease, or severe bronchial asthma. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected. have elevated carbon dioxide blood levels have a heart problem after long-term lung disease (cor pulmonale) suffer from intestinal paralysis (paralytic ileus). Signs may be that your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Oxydon if you Baca dokumen lengkap
Health Products Regulatory Authority 16 May 2022 CRN00CVPR Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxydon 10 mg Prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 10 mg oxycodone hydrochloride corresponding to 8.96 mg oxycodone. Excipient(s) with known effect: Each prolonged-release tablet contains 2.1 mg of propylene glycol and a maximum of 28 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Brown-red, biconvex, oblong prolonged-release tablets with a breakline on both sides. The prolonged-release 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. Oxydon Prolonged-release tablets are indicated in adults and adolescents aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. For doses not practicable with this medicinal product other strengths are available. _Adults and adolescents (12 years of age and older)_ _Starting dose_ The usual starting dose for an opioid naïve patient is 10 mg oxycodone hydrochloride per dose at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of adverse reactions. Patients already receiving opioids may start treatment with higher doses of Oxydon taking into account their experience with former opioid therapies. 10 to 13 mg oxycodone hydrochloride correspond to approximately 20 mg of morphine sulphate, both in the prolonged-release formulation. _Dose adjustment_ Some patients who take Oxydon Prolonged-release tablets following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Oxydon is not intended for therapy of breakthrough pain. The single dose of the rescue medication should amount to Baca dokumen lengkap