Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
LOXIFLAM is indicated for use in patients aged 12 years and older for:
The maximum recommended dose of LOXIFLAM is 15 mg daily.
Combined administration: The total daily dosage of LOXIFLAM administered as tablets, suppositories and injections should not exceed 15 mg.
Use the lowest effective dose for the shortest possible duration of treatment as the potential for adverse reactions increases with dose and duration of exposure.
15 mg/day. According to the therapeutic response, the dose may be reduced to 7,5 mg/day.
15 mg/day. According to the therapeutic response, the dose may be reduced to 7,5 mg/day.
7,5 mg/day. If necessary, the dose may be increased to 15 mg/day.
7,5 mg/day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day.
In patients with an increased risk of adverse reactions, such as the elderly, start treatment with a dose of 7,5 mg/day.
No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 mL/min). In non-dialysed patients with severe renal impairment LOXIFLAM is contraindicated (section 4.3). In patients with end-stage renal failure on haemodialysis the maximum daily dose should not exceed 7,5 mg/day.
LOXIFLAM is contraindicated in children under the age of 12 years (see section 4.3).
For oral administration.
The total daily dose of LOXIFLAM tablets should be taken as a single dose and should be swallowed with water or other fluid in conjunction with food. The maximum recommended daily dose regardless of formulation, is 15 mg (see section 4.4).
In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).
Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAID and may occur following an overdose.
Treatment is symptomatic and supportive as there is no known antidote. It has been shown in a clinical trial that cholestyramine accelerates the elimination of LOXIFLAM.
24 months.
Store at or below 25°C in well-closed containers.
Keep in original packaging until required for use.
LOXIFLAM 7,5 mg: 30 tablets are packed in a clear or red polyvinyl chloride, polyvinylidene chloride or a clear polyvinyl chloride, polyethylene, polyvinylidene chloride film sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.
LOXIFLAM 15 mg: 10 or 30 tablets are packed in a polyvinyl chloride, polyethylene, polyvinylidene chloride or red polyvinyl chloride, polyvinylidene chloride film sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.
Not all packs and pack sizes may be marketed.
No special requirements.
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