País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
TAPENTADOL HYDROCHLORIDE EQUIVALENT TO FREE BASE
Grunenthal Ltd
50 Milligram
Tablet Prolonged Release
2010-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Yantil SR 50 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). Excipient(s): Yantil SR 50 mg contains 3.026 mg lactose. For a 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 Yantil 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 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. Yantil 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 Yantil 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 Yantil SR for patients currently taking opioids compared to those not having taken opioids before initiating therapy with Yantil 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 Llegiu el document complet