Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Clonmel Healthcare Ltd
N02AA05
OXYCODONE HYDROCHLORIDE
60 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids
Authorised
2014-09-05
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXIMEL 5 MG PROLONGED-RELEASE TABLETS OXIMEL 10 MG PROLONGED-RELEASE TABLETS OXIMEL 15 MG PROLONGED-RELEASE TABLETS OXIMEL 20 MG PROLONGED-RELEASE TABLETS OXIMEL 30 MG PROLONGED-RELEASE TABLETS OXIMEL 40 MG PROLONGED-RELEASE TABLETS OXIMEL 60 MG PROLONGED-RELEASE TABLETS OXIMEL 80 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 Oximel is and what it is used for 2. What you need to know before you take Oximel 3. How to take Oximel 4. Possible side effects 5. How to store Oximel 6. Content of the pack and other information _ _ 1. WHAT OXIMEL IS AND WHAT IT IS USED FOR Oximel (active substance: oxycodone hydrochloride) is a centrally acting, strong painkiller from the group of opioids. Oximel is used to treat severe pain, which can be adequately managed only with oipoid analgesics. Oximel is indicated in adults and adolescents aged 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXIMEL DO NOT TAKE OXIMEL - if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6), - if you suffer from severely depressed breathing (respiratory Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oximel 60mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 60 mg oxycodone hydrochloride corresponding to 53.8 mg oxycodone. Excipient with known effect: Each prolonged-release tablet contains 86 mg lactose (as monohydrate). 3 PHARMACEUTICAL FORM Prolonged-release tablet Pink-red, round, biconvex, prolonged-release tablets with a diameter of 8.6 – 9.0 mm and a height of 5.0 – 5.6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. Oximel is indicated in adults and adolescents aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment. The following general dosage recommendations apply: Adults and adolescents 12 years of age and older Dose titration and adjustment In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg oxycodone hydrochloride to minimize the incidence of adverse reactions. Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. For doses not realizable/practicable with this strength other strengths of this medicinal product are available. According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Oxycodone Διαβάστε το πλήρες έγγραφο