국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
TAPENTADOL HYDROCHLORIDE
Grünenthal Ltd
N02AX06
TAPENTADOL HYDROCHLORIDE
50 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Other opioids
Authorised
2010-12-21
Material No. CMO Mat. No. Class. No. Customer Mat. No. Laetus Code Colors & Collating Marks 93024028 – 50/030/23 – 93020345 229 GI PALEXIA PR IRL 07.12.2017 V2 | DMA Previous Mat. No. Product Name Date/Version 8 pt Font Size Dimension 185 X 297 MM Grain Direction 297 MM BLACK ................. 2 PANT 123 ............. 35 PALEXIA SR 50 MG, 100 MG, 150 MG, 200 MG AND 250 MG PROLONGED-RELEASE TABLETS Tapentadol 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 PALEXIA SR is and what it is used for 2. What you need to know before you take PALEXIA SR 3. How to take PALEXIA SR 4. Possible side effects 5. How to store PALEXIA SR 6. Contents of the pack and other information 1. WHAT PALEXIA SR IS AND WHAT IT IS USED FOR The full name of your medicine is ‘PALEXIA SR 50 mg/100 mg/150 mg/200 mg/250 mg prolonged-release tablets’. It is referred to as ‘PALEXIA SR’ in the rest of this leaflet. The active ingredient of PALEXIA SR is tapentadol. PALEXIA SR belongs to the class of opioids and is used in adults to treat severe long term pain, when your doctor recommends the use of a strong painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA SR DO NOT TAKE PALEXIA SR • if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6) • if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia) • if you have no bowel movement as shown by severe constipation and bloating which may be accompanied 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Palexia SR 50 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). Excipient(s) with known effect: Palexia SR 50 mg contains 3.026 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H1” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palexia SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. PALEXIA SR should be taken twice daily, approximately every 12 hours. _Initiation of therapy_ Initiation of therapy in patients currently not taking opioid analgesics Patients should start treatment with single doses of 50 mg tapentadol as prolonged-release tablet administered twice daily. _Initiation of therapy in patients currently taking opioid analgesics_ When switching from opioids to PALEXIA SR and choosing the initial dose, the nature of the previous medicinal product, administration and the mean daily dose should be taken into account. This may require higher initial doses of PALEXIA SR for patients currently taking opioids compared to those not having taken opioids before initiating therapy with PALEXIA SR. _Titration and maintenance_ After initiation of therapy the dose should be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician. Experience from clinical trials has shown that a titration regimen in increments of 50 mg tapentadol as prolonged- release tablet twice daily every 3 전체 문서 읽기