Source: Health Products Regulatory Authority (IE) Revision Year: 2015 Publisher: Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS HP10 0DF, United Kingdom
Short-term relief of acute mild to moderate pain.
Symptomatic relief of pain and inflammation in osteoarthritis.
Symptomatic relief of pain and inflammation in rheumatoid arthritis.
For all patients the appropriate dosing regimen should be based upon individual response to treatment.
8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg.
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.
Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.
No special dosage modification is required for elderly patients above age 65, but Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4).
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).
For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4).
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4.).
At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements. However, it can be expected that after an overdose with lornoxicam, the following symptoms can be seen: Nausea, vomiting, cerebral symptoms (dizziness, disturbances in vision). Severe symptoms are ataxia ascending to coma and cramps, liver and kidney damages and maybe coagulation disorders.
In the case of a real or suspected overdose, the medicinal product should be withdrawn. Due to its short half-life, lornoxicam is rapidly excreted. Lornoxicam is not dialysable. No specific antidote is known to date. The usual emergency measures including gastric lavage should be considered. Based on principles, only administering activated charcoal immediately after the intake of lornoxicam can lead to diminished absorption of the preparation. Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.
Shelf life: 3 years.
Blister: Do not store above 30°C.
Blister: Opaque PVC/Aluminium. Each blister strip contains 10 film-coated tablets.
Pack sizes: 10, 20, 30, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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