Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TAPENTADOL HYDROCHLORIDE EQUIVALENT TO FREE BASE
Grunenthal Ltd
50 Milligram
Film Coated Tablet
2010-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Yantil 50mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg tapentadol (as hydrochloride). Excipient(s): Yantil 50 mg contains 24.74 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) White round shaped film-coated tablets of 7 mm diameter, marked with Grünenthal logo on one side and “H6” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Yantil is indicated for the relief of moderate to severe acute 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. Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements. On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved. The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician. Daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended. As soon as stable dosing regimen is achieved and longer treatment is anticipated, the possibility of switching the patient to therapy wit Read the complete document