Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Mundipharma Pharmaceuticals Limited
N02AA; N02AA05
OXYCODONE HYDROCHLORIDE
20 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone
Marketed
2000-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER _OXYNORM_ 5 MG , 10 MG AND 20 MG HARD CAPSULES 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 _OXYNORM_ is and what it is used for 2. What you need to know before you take _OXYNORM_ 3. How to take _OXYNORM_ 4. Possible side effects 5. How to store _OXYNORM_ 6. Contents of the pack and other information 1. WHAT _OXYNORM_ IS AND WHAT IT IS USED FOR These capsules have been prescribed for you by your doctor to relieve severe pain. They contain the active ingredient oxycodone which is a strong analgesic (‘painkiller’) that belongs to a group of medicines called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _OXYNORM_ DO NOT TAKE _OXYNORM_ IF YOU: • are allergic (hypersensitive) to oxycodone or any of the other ingredients of the capsules (listed in section 6 ‘Further information’) or have previously had an allergic reaction when taking other strong analgesics or painkillers (such as morphine or other opioids); • have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Symptoms may include breathlessness, coughing or breathing more slowly and weakly than expected; • have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury; • have a condition where the bowel does not work properly (paralytic ileus), your stomach empties mo Lire le document complet
Health Products Regulatory Authority 12 December 2023 CRN00CXPJ Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OxyNorm 20 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone base). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. _OXYNORM _hard capsules 20 mg are pink/beige, printed ONR 20. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _OXYNORM_ capsules is indicated in adults and adolescents(from 12 years and older) for the treatment of severe pain, which can beadequately managed only with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two "rescues" per day could be an indication that the prolonged-release dosage requires upward titration. _Adults:_ _OXYNORM _capsules should be taken at 4-6 hourly intervals. The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient's previous history of analgesic requirements should also be taken into account when determining the dose. The usual starting dose for debilitated elderly patients, opioid naïve patients or patients presenting with severe pain uncontrolled with weaker opioids is 5 mg 4-6 hourly. The dose should then be carefully titrated, every day if necessary, to achieve pain relief. Generally, the lowest effective dose for analgesia should be selected. If higher doses are necessary, increases should be made in 25-50% increments where possible. The correct dosage for any individual patient is that which controls the pain with no or tolerable side effects throughout the dosage interval. The need for escape medication more than twice a day indicates that the dosage Lire le document complet