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July 1, 2016


Company: Takeda Products Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Lornoxicam 8mg.
Description: White to yellowish round biconvex film-coated tablet.
Presentation: 30, €7.19.
Indication: Short-term relief of acute mild to moderate pain.
Pharmacology: Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams. Lornoxicams mode of action is mainly related to the inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme) leading to desensitisation of peripheral nociceptors and consequently inhibition of inflammation. A central effect on nociception, which seems to be independent of anti-inflammatory effects has also been suggested.
Dosage: Adult: 8-16mg daily. Initially, 16mg followed by 8mg 12 hours later may be administered on first treatment day. Usual maximum dose 16mg daily. Renal/hepatic impairment: 8mg once daily. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to lornoxicam, to any of the excipients or to other NSAIDs including acetylsalicylic acid. Thrombocytopenia. Severe heart failure. Gastrointestinal bleeding (or history of), cerebrovascular bleeding or other bleeding disorders. Recurrent peptic ulcer/haemorrhage (or history of). Severe hepatic or renal impairment. Pregnancy, lactation.
Special precautions: Caution: Mild to moderate renal impairment, hepatic impairment, blood coagulation disorders, history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) or ulcer, long term therapy, elderly, major surgery, congestive heart failure, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), bronchial asthma (or history of), systemic lupus erythematosus, mixed connective tissue disorders. Small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis reported very rarely. May impair fertility. Varicella (avoid use). Monitor hepatic and renal function; discontinue if abnormal values are significant or persist. Driving/using machines.
Drug interactions: Avoid: Other NSAIDs. Cimetidine, anti-coagulants, phenprocoumon, heparin, anti-hypertensives, digoxin, corticosteroids, quinolone antibiotics, anti-platelet agents, methotrexate, SSRIs, lithium, cyclosporine, sulphonylureas, CYP2C9 inducers/inhibitors, tacrolimus, pemetrexed, diuretics, nephrotoxic drugs.
Adverse drug reactions: GI upset, headache, dizziness.
Full prescribing information and references available from Takeda Products Ireland Ltd. Telephone: (01) 6420021. Fax: (01) 6420020.