Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxycodone hydrochloride; Naloxone hydrochloride
Napp Pharmaceuticals Ltd
Oxycodone hydrochloride; Naloxone hydrochloride
10mg ; 5mg
Modified-release tablet
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012854029576
PACKAGE LEAFLET: INFORMATION FOR THE USER _TARGINACT_ ® 5 MG/2.5MG, 10 MG/5_ _MG, 20 MG/ 10 MG AND 40 MG/20_ _MG PROLONGED-RELEASE TABLETS Oxycodone hydrochloride and 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 _TARGINACT_ tablets are and what they are used for 2. What you need to know before you take _TARGINACT_ tablets 3. How to take _TARGINACT_ tablets 4. Possible side effects 5. How to store _TARGINACT_ tablets 6. Contents of the pack and other information 1. WHAT _TARGINACT_ TABLETS ARE AND WHAT THEY ARE USED FOR _ _ _TARGINACT_ 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 _TARGINACT_ tablets for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract constipation. HOW THESE TABLETS WORK IN PAIN RELIEF These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone is responsible for the painkilling effect of the tablets. It is a strong analgesic (‘painkiller’) that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers. RESTLESS LEGS SYNDROME You have been prescribed _TARGINACT _tablets for the second line symptomatic treatment of severe to very seve Läs hela dokumentet
OBJECT 1 TARGINACT 5 MG/2.5 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 02-Jan-2018 | Napp Pharmaceuticals Limited 1. Name of the medicinal product _TARGINACT_ _®_ _ _5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release tablets 2. Qualitative and quantitative composition _TARGINACT _5 mg/2.5 mg Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone and 2.5 mg naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.25 mg naloxone. _TARGINACT_ 10 mg/5 mg Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9.0 mg oxycodone and 5 mg naloxone hydrochloride as 5.45 mg of naloxone hydrochloride dihydrate equivalent to 4.5 mg naloxone. _TARGINACT_ 20 mg/10 mg Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18 mg oxycodone and 10 mg of naloxone hydrochloride as 10.9 mg of naloxone hydrochloride dihydrate equivalent to 9 mg naloxone. _TARGINACT _40 mg/20 mg Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36 mg oxycodone and 20 mg of naloxone hydrochloride as 21.8 mg of naloxone hydrochloride dihydrate equivalent to 18 mg naloxone Excipient with known effect: _TARGINACT _5 mg/2.5 mg Each prolonged-release tablet contains 68.2 mg lactose anhydrous. _TARGINACT_ 10 mg/5 mg Each prolonged-release tablet contains 61.0 mg lactose anhydrous. _TARGINACT_ 20 mg/10 mg Each prolonged-release tablet contains 51.8 mg lactose anhydrous. _TARGINACT _40 mg/20 mg 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 _TARGINACT _5 mg/2.5 mg Blue, oblong tablets, with a nominal length of 9.5 mm and with a film coating, embossed “OXN” on one side and “5” on the other side. _TARGINACT_ 10 mg/5 mg White, oblong tablets, with a nominal length of 9.5 mm and with a film coating, embossed “OXN” on on Läs hela dokumentet