PONSTAN

What it is

PONSTAN contains the active ingredient mefenamic acid 250 mg per capsule. Mefenamic acid is one of the fenamate series of non-steroidal anti-inflammatory agents. PONSTAN has demonstrated analgesic, anti-inflammatory and antipyretic properties in human clinical studies and in classical animal test systems. These effects may be due to PONSTAN's dual action on prostaglandins, as it inhibits the enzymes of prostaglandin synthetase and also antagonises the actions of prostaglandin at the receptor sites.

Approved indications

— Treatment of primary dysmenorrhoea and primary menorrhagia. — Short-term relief of mild to moderate pain such as dental pain and soft tissue pain.

Dosing overview

For dysmenorrhoea, the dose is 2 capsules (500 mg) three times daily with meals from the onset of pain and continued for the usual duration of pain. For menorrhagia, the dose is 2 capsules (500 mg) three times daily with meals and from the onset of menses and continued according to the judgement of the physician. Therapy should not be continued for more than 7 days except on the advice of a physician. For other indications, the dose is 2 capsules (500 mg) three times daily, with meals. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Key safety warnings

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal, and this risk may increase with dose or duration of use. To minimise the potential risk for an adverse cardiovascular event in patients treated with mefenamic acid, especially in patients with cardiovascular risk factors, the lowest effective dose should be used for the shortest duration possible. NSAIDs, including mefenamic acid, can cause serious, potentially fatal gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, and the frequency of such events may increase with dose or duration of use, but can occur at any time without warning. <cite index index="1-49">Patients most at risk of developing gastrointestinal complications with NSAIDs are the elderly; patients with cardiovascular disease; patients using concomitant corticosteroids, anti-platelet drugs (such as aspirin), or selective serotonin reuptake inhibitors (SSRIs); patients with a history of, or active, gastrointestinal disease (such as ulceration, bleeding or inflammatory conditions); and patients ingesting alcohol or with a history of smoking and alcoholism.</cite> NSAIDs may very rarely cause serious cutaneous adverse events such as drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative dermatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and generalised bullous fixed drug eruption (GBFDE) which can be fatal and occur without warning. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash, mucosal lesion or any other sign of hypersensitivity. If diarrhoea occurs, PONSTAN should be promptly discontinued.

Contraindications

PONSTAN is contraindicated in patients showing evidence of chronic inflammation and/or active ulceration of either the upper or lower gastrointestinal tract and patients with pre-existing renal disease. PONSTAN is contraindicated in patients in whom aspirin and/or other non-steroidal anti-inflammatory drugs (NSAIDs) have induced symptoms of bronchospasm, allergic rhinitis or urticaria, because the potential exists for cross-sensitivity. PONSTAN is contraindicated in patients with impaired renal function and in patients with severe hepatic impairment. PONSTAN is contraindicated in patients previously experiencing diarrhoea on taking this drug. PONSTAN is contraindicated in patients who have previously exhibited hypersensitivity to mefenamic acid or any of the components of PONSTAN. PONSTAN is contraindicated in patients with severe heart failure. Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery is contraindicated. PONSTAN is contraindicated in children under 14 years of age. PONSTAN is contraindicated in patients in the third trimester of pregnancy or who are breastfeeding.

Regulatory history

PONSTAN was first approved on 20 September 1991 for the blister pack of 20 capsules. The blister pack of 50 capsules was approved on 29 July 2014. The product information was last revised on 27 October 2023.