País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LORNOXICAM
Nycomed UK Limited
8 Milligram
Film Coated Tablet
2009-05-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xefo Rapid 8 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 8 mg lornoxicam. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to yellowish round biconvex film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term relief of acute mild to moderate pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For all patients the appropriate dosing regimen should be based upon individual response to treatment. Acute pain 8-16 mg lornoxicam given in doses of 8 mg. An initial dose of 16 mg followed by 8 mg 12 hours later can be given on the first treatment day. After the first treatment day the maximum recommended daily dose is 16 mg. Xefo Rapid film-coated tablets are supplied for oral administration and should be taken with a sufficient quantity of liquid. Additional information on special populations Children and adolescents Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy. Elderly No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4). Renal impairment Reduction of dose frequency of Xefo Rapid to once daily in patients suffering from renal impairment is recommended. Hepatic impairment Reduction of dose frequency of Xefo Rapid to once daily in patients suffering from hepatic impairment is recommended. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms Leer el documento completo