Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Tapentadol Phosphate
Neuraxpharm Ireland Limited
N02AX06
Tapentadol Phosphate
Prolonged-release tablet
tapentadol
Not marketed
2022-11-04
2 PACKAGE LEAFLET: INFORMATION FOR THE USER TAPIMIO25 MG PROLONGED-RELEASE TABLETS TAPIMIO 50 MG PROLONGED-RELEASE TABLETS TAPIMIO 100 MG PROLONGED-RELEASE TABLETS TAPIMIO 150 MG PROLONGED-RELEASE TABLETS TAPIMIO 200 MG PROLONGED-RELEASE TABLETS TAPIMIO 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 Tapimio is and what it is used for 2. What you need to know before you take Tapimio 3. How to take Tapimio 4. Possible side effects 5. How to store Tapimio 6. Contents of the pack and other information 1. WHAT TAPIMIO IS AND WHAT IT IS USED FOR Tapentadol - the active substance in Tapimio - is a strong painkiller which belongs to the class of opioids. Tapimio is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAPIMIO DO NOT TAKE TAPIMIO • 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 paralysis of the gut • if you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see “Other medicines and Tapimio”) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tapimio if you: • have slow or shallow breathing, • suffer from increased pressure in the brai Прочитайте повний документ
Health Products Regulatory Authority 24 November 2022 CRN00D70R Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tapimio 150 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains tapentadol phosphate equivalent to 150 mg tapentadol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Bright reddish, oblong, biconvex prolonged-release tablets (7 mm x 15 mm) with score lines on both sides. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tapimio 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. Tapimio 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 Tapimio administered twice daily. _Initiation of therapy in patients currently taking opioid analgesics_ When switching from opioids to Tapimio 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 Tapimio for patients currently taking opioids compared to those not having taken opioids before initiating therapy with Tapimio. _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 prolonged release tapentadol twice daily every 3 days was appropria Прочитайте повний документ