Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Actavis Group PTC ehf
N02AA05
OXYCODONE HYDROCHLORIDE
20 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids
Authorised
2013-02-01
AAAI5210 Oxycodone 5mg, 10mg, 20mg capsules, hard PIL - Ireland item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAI5210 2 23.11.15 DR 16.06.16 DR Dupnitsa 145x600 9pt 25.11.15 25.11.15 OXYCODONE ACTAVIS 5 MG CAPSULES, HARD OXYCODONE ACTAVIS 10 MG CAPSULES, HARD OXYCODONE ACTAVIS 20 MG CAPSULES, HARD Oxycodone hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER 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 ACTAVIS IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYCODONE ACTAVIS 3 HOW TO TAKE OXYCODONE ACTAVIS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE OXYCODONE ACTAVIS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT OXYCODONE ACTAVIS IS AND WHAT IT IS USED FOR Oxycodone Actavis is a centrally acting, strong painkiller from the group of opioids. Oxycodone Actavis is used to treat severe pain, which can only be adequately managed with opioid analgesics. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYCODONE ACTAVIS DO NOT TAKE OXYCODONE ACTAVIS • 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 depression) Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxycodone Actavis 20 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20.0 mg oxycodone hydrochloride corresponding to 17.93 mg oxycodone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) Hard capsules, 14.4 mm in length, with a light pink body marked with ‘20’ and a brown cap marked with ‘OXY’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can only be adequately managed with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment. The followinggeneral dose recommendations apply: Adults and adolescents over 12 years of age _Dose initiation_ In general, the initial dose for opioid naïve patients is 5 mg oxycodone hydrochloride given at intervals of 6 hours.Patients already receiving opioids may start treatment with higher doses taking into account their experience withformer opioid therapies. Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio:10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It should be noted that this is a guide to the dose ofoxycodone hydrochloride capsules required. Inter-patient variability requires that each patient is carefully titrated tothe appropriate dose. _Dose adjustment_ Increasing severity of pain will require an increased dose of Oxycodone Actavis. The dose should be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. In doing so, the dosing interval may be reduced to 4 hours.The correct dose for any individual patient is that which controls the pain and is well tolerated throughout the dosingperiod. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higherdoses. In patients receiving a prolonged-release formulati Prečítajte si celý dokument