Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
Mundipharma Pharmaceuticals Limited
N02AA; N02AA55
OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate
40 mg/20 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone, combinations
Marketed
2009-09-25
PACKAGE LEAFLET: INFORMATION FOR THE USER _TARGIN_ 5 MG/2.5 MG PROLONGED-RELEASE TABLETS _TARGIN_ 10 MG/5 MG PROLONGED-RELEASE TABLETS _TARGIN_ 20 MG/10 MG PROLONGED-RELEASE TABLETS _TARGIN_ 40 MG/20 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 _TARGIN_ is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours. These tablets are only for use in adults. Pain relief 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. How these tablets work in pain relief These tablets contain 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. Restless legs syndrome You have been prescribed _TARGIN_ for the Läs hela dokumentet
Health Products Regulatory Authority 06 June 2023 CRN00D5YW Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Targin 40 mg/20 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged‑release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36 mg oxycodone and 20 mg naloxone hydrochloride as 21.8 mg of naloxone hydrochloride dihydrate equivalent to 18 mg naloxone. Excipient with known effect: Each prolonged‑release tablet contains 103.6 mg lactose anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged‑release tablet Yellow, oblong tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on one side and “40” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. Second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy. 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 Analgesia 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, these tablets 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. Health Products Regulatory Authority 06 June 2023 CRN00D5YW Page 2 of 17 Patients already receiving opioids may be started on higher doses depending on their previous opioid exper Läs hela dokumentet