국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Mundipharma Pharmaceuticals Limited
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
80 mg/40 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Marketed
2016-02-16
PACKAGE LEAFLET: INFORMATION FOR THE USER _TARGIN_ 60 MG/30 MG PROLONGED-RELEASE TABLETS _TARGIN_ 80 MG/40 MG PROLONGED-RELEASE TABLETS Oxycodone hydrochloride / naloxone 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 _TARGIN_ is and what it is used for 2. What you need to know before you take _TARGIN_ 3. How to take _TARGIN_ 4. Possible side effects 5. How to store _TARGIN_ 6. Contents of the pack and other information 1. WHAT _TARGIN_ IS AND WHAT IT IS USED FOR How _TARGIN_ works _TARGIN_ contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of _TARGIN_ , and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of _TARGIN_ , naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers. You have been prescribed _TARGIN_ for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation. _TARGIN _ are only for use in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _TARGIN_ DO NOT TAKE _TARGIN_ • if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride or any of the other ingredients of this medicine (listed in section 6), • if your breathing is not able to supply enough oxygen to the blood, and get rid of carbon dioxide produced in the body (re 전체 문서 읽기
Health Products Regulatory Authority 06 June 2023 CRN00D5YW Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Targin 80 mg/40 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged‑release tablet contains 80 mg of oxycodone hydrochloride equivalent to 72 mg oxycodone and 40 mg naloxone hydrochloride as 43.6 mg of naloxone hydrochloride dihydrate, equivalent to 36 mg naloxone. Excipient with known effect: Each prolonged‑release tablet contains 45.2 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged‑release tablet Brown, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on one side and “80” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid‑induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Targin is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The analgesic efficacy of Targin is equivalent to oxycodone hydrochloride prolonged‑release formulations. The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, Targin should be administered as follows: _Adults_ The usual starting dose for an opioid naive patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals. Lower strengths are available to facilitate dose titration when initiating opioid therapy and for individual dose adjustment. Patients already receiving opioids may be started on higher doses depending on their previous opioid experience. The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. The maximum daily dose is reserved for patients who have previously been maintained on a stable daily dose and who have become 전체 문서 읽기