Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa
MOTIFINE is indicated for the emergency treatment of acute gout attacks.
Use the lowest effective dose for the shortest possible duration of treatment.
One capsule daily. Dose may be increased to two capsules daily if necessary, with a maximum daily dose of 150 mg. The first dose should be taken in the morning with breakfast and the second if required 8–12 hours later. The maximum treatment period of 3 days should not be exceeded.
Not for use in children.
Elderly patients are at increased risk of the serious consequences of adverse reactions. If MOTIFINE is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during MOTIFINE therapy.
For oral administration.
The capsules should be swallowed whole with a liberal quantity of liquid.
To be taken preferably with or after food.
Symptoms included headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, and occasional convulsions. In case of significant poisoning, acute renal failure and liver damage are possible. Treatment is symptomatic and supportive, especially for hypotension, renal failure, convulsions, gastro-intestinal irritation and respiratory depression.
Absorption should be prevented as soon as possible after an overdose by means of gastric lavage and activated charcoal.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Frequent or prolonged convulsions should be treated with intravenous diazepam. Specific therapies such as forced diuresis, dialysis or haemoperfusion are of little value in eliminating MOTIFINE because of its high protein binding and extensive metabolism.
48 months.
Store at or below 25°C. Protect from moisture.
The capsules should be stored in the blister strips until required for use.
The capsules are blister packed in white opaque PVC/PVDC and silver aluminium foil and packed into outer cardboard cartons.
Pack size: 6 capsules.
Not applicable.
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