Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Chemidex Pharma Limited, 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 demonstrable 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.
2. Primary dysmenorrhoea.
3. Menorrhagia due to dysfunctional causes and presence of an IUD when other pelvic pathology has been ruled out.
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.
1 tablet (500 mg) three times daily.
In menorrhagia to be administered on the first day of excessive bleeding and continued according to the judgement of the physician.
In dysmenorrhoea to be administered at the onset of menstrual pain and continued according to the judgement of the physician.
As for adults.
Whilst no pharmacokinetic or clinical studies specific to the elderly have been undertaken with Ponstan Forte, it has been used at normal dosage in trials which included many elderly patients.
The elderly 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.
Ponstan Forte should be used with caution in elderly patients suffering from dehydration and renal disease. Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic acid after the development of diarrhoea.
It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50 mg/5ml).
For oral administration.
Ponstan Forte tablets should be taken preferably with or after food.
It is important that the recommended dose is not exceeded and the regime adhered to since some reports have involved daily dosages under 3g.
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.
Amber polystyrene bottle: 3 years.
Blister and HDPE DUMA and polypropylene container: 4 years.
Do not store above 30°C.
a) Aluminium foil/pvc blister pack in cardboard carton. Pack sizes: 28 and 100 tablets.
b) HDPE DUMA and polypropylene container. Pack sizes: 100 and 500 tablets.
c) Amber polystyrene bottle with a high density polyethene anti-arthritic closure. Pack sizes: 6, 12, 84, 100 and 500 tablets.
Not all pack sizes may be marketed.
No special requirements.
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