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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xefo 8 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 8 mg lornoxicam
Excipients: 90 mg Lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish oblong film-coated tablet with imprint “L08”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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Short-term relief of acute mild to moderate pain
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Symptomatic relief of pain and inflammation in osteoarthritis.
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Symptomatic relief of pain and inflammation in rheumatoid arthritis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For all patients the appropriate dosing regimen should be based upon individual response to treatment.
Pain
8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg.
Osteoarthritis and Rheumatoid arthritis
Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. Maintenance dose should not exceed 16
mg lornoxicam daily.
Xefo film-coated tablets are supplied for oral use 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
For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3
doses (see section 4.4).
Hepatic impairment
IRISH MEDICINES
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