Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Tapentadol Tartrate
Laboratorios LICONSA, S.A.
N02AX06
Tapentadol Tartrate
Prolonged-release tablet
tapentadol
2022-08-05
PACKAGE LEAFLET: INFORMATION FOR THE USER TAPENTADOL LICONSA 25 MG PROLONGED-RELEASE TABLETS TAPENTADOL LICONSA 50 MG PROLONGED-RELEASE TABLETS TAPENTADOL LICONSA 100 MG PROLONGED-RELEASE TABLETS TAPENTADOL LICONSA 150 MG PROLONGED-RELEASE TABLETS TAPENTADOL LICONSA 200 MG PROLONGED-RELEASE TABLETS TAPENTADOL LICONSA 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 your 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 Tapentadol Liconsa is and what it is used for 2. What you need to know before you takeTapentadol Liconsa 3. How to take Tapentadol Liconsa 4. Possible side effects 5. How to store Tapentadol Liconsa 6. Contents of the pack and other information 1. WHATTAPENTADOL LICONSA IS AND WHAT IT IS USED FOR Tapentadol the active substance in Tapentadol Liconsa, is a strong painkiller which belongs to the class of opioids. Tapentadol Liconsa is used for the treatment of severe long-term pain in adults that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKETAPENTADOL LICONSA DO NOT TAKE TAPENTADOL LICONSA IF YOU • are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6), • have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia), • have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach, • have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotro Lue koko asiakirja
Health Products Regulatory Authority 13 January 2023 CRN00D6TS Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tapentadol Liconsa 250 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains tapentadol tartrate equivalent to 250 mg of tapentadol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Red brown, oblong and biconvex prolonged-release tablet, with a length of approximately 21 mm and a width of approximately 7.5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tapentadol Liconsa 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 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. Tapentadol Liconsa 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 Tapentadol Liconsa 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 Tapentadol Liconsa for patients currently taking opioids compared to those not having taken opioids before initiating therapy with Tapentadol Liconsa. _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 Lue koko asiakirja