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XEFO RAPID 8 MG FILM-COATED TABLETS

Information leaflet

                                                     Irish Medicines Board




                                  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 (see section 4.4.).




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Date Printed 08/03/2011                               CRN 2078044                                         page number: 1
                                                   Irish Medicines Board




 4.3 Contraindications

        Hypersensitivity to lornoxicam or to any of the excipients
        Thrombocytopenia
        Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including
        acetylsalicylic acid
        Severe heart failure
        Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders
        History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
        Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or
        bleeding)
        Severe hepatic impairment
        Severe renal impairment (Serum creatinine > 700 µmol/l)
        The third trimester of pregnancy (see section 4.6).

 4.4 Special warnings and precautions for use

 For the following disorders, lornoxicam should only be administered after careful risk-benefit assessment:
          Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine
         150-300 µmol/l) to moderate (serum creatinine 300 – 700 µmol/l) renal impairment due to dependency on renal
         prostaglandins for maintenance of renal blood flow. Treatment with lornoxicam should be discontinued if renal
         function deteriorates during treatment.
          Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving
         treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able
         to cause kidney damage.
          Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is
         recommended (e.g. APTT).
          Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals
         should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC)
         may occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to
         affect pharmacokinetic parameters of lornoxicam as compared to healthy subjects.
          Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin),
         renal functions (creatinine) and liver enzymes are recommended.
          Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. Precaution is
         advised in elderly postoperative patients.

 The use of lornoxicam with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

 Undesirable effects may be minimised by using lowest effective dose for the shortest duration necessary to control
 symptoms (see section 4.2, and GI and cardiovascular risks below).

 Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has
 been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of
 serious GI events.

 The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of
 ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients
 should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol
 or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose
 acetylsalicylic acid or other active substances likely to increase gastrointestinal risk (see below and section 4.5).
 Clinical monitoring at regular intervals is recommended.




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Date Printed 08/03/2011                               CRN 2078044                                         page number: 2
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