Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Rowex Ltd
N02AA; N02AA05
OXYCODONE HYDROCHLORIDE
5 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone
Not marketed
2017-12-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXYCODONE HYDROCHLORIDE ROWEX 5 MG HARD CAPSULES OXYCODONE HYDROCHLORIDE ROWEX 10 MG HARD CAPSULES OXYCODONE HYDROCHLORIDE ROWEX 20 MG HARD CAPSULES oxycodone hydrochloride For use in adults and adolescents aged 12 years and older 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 Oxycodone hydrochloride Rowex is and what it is used for 2. What you need to know before you take Oxycodone hydrochloride Rowex 3. How to take Oxycodone hydrochloride Rowex 4. Possible side effects 5. How to store Oxycodone hydrochloride Rowex 6. Contents of the pack and other information 1. WHAT OXYCODONE HYDROCHLORIDE ROWEX IS AND WHAT IT IS USED FOR Oxycodone hydrochloride Rowex contains the active substance oxycodone hydrochloride which is a strong painkiller of the group of opioids. Oxycodone hydrochloride Rowex 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 OXYCODONE HYDROCHLORIDE ROWEX DO NOT TAKE OXYCODONE HYDROCHLORIDE ROWEX 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 Citiți documentul complet
Health Products Regulatory Authority 25 March 2024 CRN00F50W Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxycodone hydrochloride Rowex 5 mg Hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg oxycodone hydrochloride, equivalent to 4.48 mg oxycodone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard capsules of 14.4 mm in length with a dark pink body imprinted with 5 and a brown cap imprinted with OXY. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. Oxycodone hydrochloride Rowex is indicated in adults and adolescents of 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the intensity of pain and the patient's individual response to the treatment. In general, the lowest effective analgesic dose should be chosen. The following general dose recommendations apply: _Adults and adolescents (12 years of age and older)_ _Starting dose_ In general, the initial dose for opioid naïve patients is 5 mg oxycodone hydrochloride at intervals of 6 hours. Patients already receiving opioids may start treatment with higher doses (under consideration of their experience with former opioid therapies). In patients who have received oral morphine prior to oxycodone therapy, the daily dose is based on the fact that 10 to 13 mg of oral oxycodone hydrochloride are equivalent to approximately 20 mg of oral morphine sulphate. It should be noted that this is a guideline value for the required dose of hard capsules containing oxycodone hydrochloride. Treatment should be titrated to the adequate dose on an individual basis for each patient due to the inter-individual variability. _Dose adjustment_ The dose should be increased with increasing pain intensity. If necessary, it should be carefully titrated, as frequent as once a day if necessary, to achieve adequate pain relief. The dose interval can simultaneously be red Citiți documentul complet