Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Chemidex Pharma Limited (Trading as Chemidex Generics and/or Essential Generics), Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom
Mefenamic acid is a non-steroidal anti-inflammatory agent with analgesic properties, and a demonstratable antipyretic effect. It has been shown to inhibit prostaglandin activity.
Indications:
1. As an anti-inflammatory analgesic for the symptomatic relief of rheumatoid arthritis (including Still’s Disease), osteoarthritis, and pain including muscular, traumatic and dental pain, headaches of most aetiology, post-operative and post-partum pain, pyrexia in children.
2. Primary dysmenorrhoea in older children.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Do not exceed the stated dose.
It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50mg/5ml) in the following dosage regime:
Infants over 6 months – 25mg/kg of bodyweight daily in divided doses, or,
6 months to under 2 years – one 5 ml spoonful
2 years to under 5 years – two 5 ml spoonfuls
5 years to under 9 years – three 5 ml spoonfuls
9 years to 12 years – four 5 ml spoonfuls
Doses may be repeated as necessary, up to three times daily.
Mefenamic acid suspension should be taken preferably with or after food.
Apart from the treatment of Still’s Disease, therapy should not be continued for longer than 7 days in children.
Although mefenamic acid suspension is not indicated to be used by the elderly, if used in elderly patients, these patients are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
For oral administration.
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally convulsions [Mefenamic acid has a tendency to induce tonic-clonic (grand mal) convulsions in overdose]. In cases of significant poisoning acute renal failure and liver damage are possible.
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount activated charcoal should be considered. Alternatively, in adults gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient’s clinical condition.
Haemodialysis is of little value since mefenamic acid and its metabolites are firmly bound to plasma proteins.
3 years.
Store below 30°C.
Clear amber glass bottle (type III glass) with a tamper evidentchild-resistant cap constructed of polypropylene (PP) body and interior, low density polyethylene (LDPE) ring and polyethylene liner.
Pack size 30 and 125 ml.
Not all pack sizes may be marketed.
No special requirements.
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