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Ponstan forte

Travellers familiar with Ponstan forte from the United Kingdom or the Eastern Mediterranean are unlikely to encounter the same brand elsewhere — it is registered in only seven countries. The footprint spans an unusual mix of markets, including the United Kingdom, Ireland, Egypt, Lebanon, and Turkey, with Finland and Malta completing the list.

The active ingredient is mefenamic acid, a nonsteroidal anti-inflammatory classified within the broader analgesic, anti-inflammatory, and antipyretic categories. Ponstan forte is prescribed in the management of pain of varied origins — including dental pain, headache, toothache, and musculoskeletal pain associated with osteoarthritis, rheumatoid arthritis, and myositis. The structured indication list further down this page sets out the registered uses recognised by the regulators in the markets where the brand is sold.

Outside this small group of markets, the Ponstan forte name will often be unfamiliar at the pharmacy counter, but mefenamic acid itself is a long-established molecule that circulates internationally under several other brand names and as a generic. A traveller or expatriate looking for an equivalent in a new country will usually be looking for the active ingredient rather than the specific brand. The wider nonsteroidal anti-inflammatory class is also represented worldwide under many different molecules, each with its own clinical positioning.

A local pharmacist is generally the right first point of contact for confirming whether mefenamic acid is stocked in a given country and under what name, and whether prescription rules apply locally. Because nonsteroidal anti-inflammatory therapy depends on individual circumstances and concurrent medications, any decision about starting, continuing, or substituting Ponstan forte belongs with a qualified healthcare provider who knows the patient's history.

Countries
Egypt Finland Ireland Lebanon Malta Turkey United Kingdom
Diseases
Dental Pain Arthritis,Osteoarthritis Rheumatoid Arthritis Headache Toothache Osteoarthritis Myositis Menorrhagia
Ingredients
Mefenamic acid
Drug Actions
Analgesic Anti-inflammatory Antipyretic Nonsteroidal anti-inflammatory
How does this drug class actually work?
Read the plain-language explainer in Pharmacology Academy (Non-steroidal anti-inflammatory drugs) →

Drugs with the same active ingredients

Ponstil forte Mefenabene Mefenam Parkemed Jen ton yan M.f.n. Vahspas Xappy-dr Amifen Dysmen Ponstan Pontin Dolfenal Mefenamic acid Ponstel Mefenamic acid amdipharm мефенаминка Padomil Painnox Painstop (mefenamic acid)

Overdose

It is important that the recommended dose is not exceeded and the regime adhered to since some reports have involved daily dosages under 3g.

(a) Symptoms

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.

(b) Therapeutic measure

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.

Shelf life

36 months for amber polystyrene bottle

48 months for blister and HDPE DUMA and polypropylene container

List of excipients

Lactose, pregelatinised starch, maize starch, povidone, silicon dioxide, talc, magnesium stearate, croscarmellose sodium type A, sodium laurilsulfate, purified water*, Opadry OY-LS-22808 (H.P.M.C.2910 15cP, lactose, polyethylene glycol 4000, vanillin, E104, E110, E171), Opaglos AG7350 (purified water, beeswax white, carnauba wax yellow, polysorbate 20, sorbic acid).

*not detectable

Undesirable effects

The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract.

Diarrhoea occasionally occurs following the use of mefenamic acid. Although this may occur soon after starting treatment, it may also occur after several months of continuous use. The diarrhoea has been investigated in some patients who have continued this drug in spite of its continued presence. These patients were found to have associated proctocolitis. If diarrhoea does develop the drug should be withdrawn immediately and this patient should not receive mefenamic acid again.

Frequencies are not known for the following adverse reactions:

Blood and the lymphatic system disorders

Haemolytic anaemia*, anaemia, hypoplasia bone marrow, haematocrit decreased, thrombocytopenic purpura, temporary lowering of the white blood cell count (leukopenia) with a risk of infection, sepsis, and disseminated intravascular coagulation.

Agranulocytosis, aplastic anaemia, eosinophilia, neutropenia, pancytopenia, thrombocytopenia.

*reversible when mefenamic acid is stopped

Immune system disorders

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea or (c) assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema, and more rarely exfoliative or bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Metabolism and nutritional disorders

Glucose intolerance in diabetic patients, hyponatraemia.

Pyschiatric disorders

Confusion, depression, hallucinations, nervousness.

Nervous system disorders

Optic neuritis, headaches, paraesthesia, dizziness, drowsiness, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.

Blurred vision, convulsions, insomnia.

Eye disorders

Eye irritation, reversible loss of colour vision, visual disturbances.

Ear and labyrinth disorders

Ear pain, tinnitus, vertigo.

Cardiac / Vascular disorders

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Palpitations.

Hypotension.

Respiratory, thoracic and mediastinal disorders

Asthma, dyspnoea.

Gastrointestinal disorders

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed.

Elderly or debilitated patients seem to tolerate gastrointestinal ulceration or bleeding less well than other individuals and most spontaneous reports of fatal GI events are in this population.

Anorexia, colitis, enterocolitis, gastric ulceration with or without haemorrhage, pancreatitis, steatorrhea.

Hepato-bilary disorders

Borderline elevations of one or more liver function tests, cholestatic jaundice.

Mild hepatotoxicity, hepatitis, hepatorenal syndrome.

Skin and subcutaneous tissue disorders

Angioedema, laryngeal oedema, erythema multiforme, face oedema, bullous reactions including Lyell's syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome, perspiration, rash, photosensitivity reaction, pruritus and urticaria.

Renal and urinary disorders

Allergic glomerulonephritis, acute interstitial nephritis, dysuria, haematuria, nephrotic syndrome, non-oliguric renal failure (particularly in dehydration), proteinuria, renal failure including renal papillary necrosis.

General disorders

Fatigue, malaise, multi-organ failure, pyrexia.

Investigations

A positive reaction in certain tests for bile in the urine of patients receiving Mefenamic acid has been demonstrated to be due to the presence of the drug and its metabolites and not to the presence of bile.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Preclinical safety data

Preclinical safety data does not add anything of further significance to the prescriber.

Pharmacodynamic properties

ANIMAL MODELS

Mefenamic acid is non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.

Its anti-inflammatory effect was first established in the UV erythema model of inflammation. Further studies included inhibition of granulation tissue growth into subcutaneous cotton pellets in rats and carrageenin induced rat paw oedema tests.

Antipyretic activity was demonstrated in yeast-induced pyresis in rats. In this model its antipyretic activity was roughly equal to that of phenylbutazone and flufenamic acid, but less than that of indomethacin.

Analgesic activity was demonstrated in tests involving pain sensitivity of rats paws inflamed by brewers yeast. Mefenamic acid was less potent than flufenamic acid in this model.

Prostaglandins are implicated in a number of disease processes including inflammation, modulation of the pain response, dysmenorrhoea, menorrhagia and pyrexia.

In common with most NSAIDs mefenamic acid inhibits the action of prostaglandin synthetase (cyclo oxygenase). This results in a reduction in the rate of prostaglandin synthesis and reduced prostaglandin levels.

The anti-inflammatory activity of NSAIDs in the rat paw oedema test has been correlated with their ability to inhibit prostaglandin synthetase. When mefenamic acid is ranked in both these tests it falls between indomethacin and phenylbutazone and it is probable that inhibition of prostaglandin synthesis contributes to the pharmacological activity and clinical efficacy of mefenamic acid.

There is also considerable evidence that the fenamates inhibit the action of prostaglandins after they have been formed. They therefore both inhibit the synthesis and response to prostaglandins. This double blockade may well be important in their mode of action.

Pharmacokinetic properties

Absorption and Distribution

Mefenamic acid is absorbed from the gastro intestinal tract. Peak levels of 10 mg/l occur two hours after the administration of a 1g oral dose to adults.

Metabolism

Mefenamic acid is predominantly metabolised by cytochrome P450 enzyme CYP2C9 in the liver, first to a 3 hydroxymethyl derivative (metabolite I) and then a 3 carboxyl derivative (metabolite II). Both metabolites undergo secondary conjugation to form glucuronides.

Therefore in patients who are known or suspected to be poor CYP2C9 metabolisers based on previous history/experience with other CYP2C9 substrates, mefenamic acid should be administered with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.

Elimination

Fifty two percent of a dose is recovered from the urine, 6% as mefenamic acid, 25% as metabolite I and 21% as metabolite II. Assay of stools over a 3 day period accounted for 10-20 % of the dose chiefly as unconjugated metabolite II.

The plasma levels of unconjugated mefenamic acid decline with a half life of approximately two hours.

Date of revision of the text

12/07/2015

Marketing authorisation holder

Chemidex Pharma Limited

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey TW20 8RB

United Kingdom

Special precautions for storage

Store below 30°C.

Nature and contents of container

a) Aluminium foil/pvc blister pack in cardboard carton. Pack sizes: 100

b) HDPE DUMA and polypropylene container. Pack sizes: 100 and 500

c) Amber polystyrene bottle with a high density polyethene anti-arthritic closure. Pack sizes: 6, 12, 84, 100 and 500.

Marketing authorisation number(s)

PL 17736/0007

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Special precautions for disposal and other handling

Not applicable

Date of first authorisation/renewal of the authorisation

10/10/2005

Frequently asked questions

What conditions does Ponstan forte treat?

Ponstan forte is prescribed for the management of pain across a range of contexts, including dental pain, headache, toothache, and musculoskeletal pain associated with osteoarthritis, rheumatoid arthritis, and myositis. As a nonsteroidal anti-inflammatory, it sits within the wider category of medications used for pain, inflammation, and fever. The structured indication block below this introduction lists the registered uses in each market where the brand is sold.

Which active substance is in Ponstan forte?

Ponstan forte contains mefenamic acid, a nonsteroidal anti-inflammatory with analgesic and antipyretic properties. Mefenamic acid is a long-established molecule that is sold internationally under several different brand names and as a generic, so a product encountered abroad with a different label may contain the same active ingredient. A pharmacist can confirm equivalence on a case-by-case basis.

In how many countries is Ponstan forte available?

Ponstan forte is registered in seven countries, with a footprint that spans the United Kingdom, Ireland, Finland, Malta, Turkey, Lebanon, and Egypt. Outside this group the specific brand is largely unfamiliar, although mefenamic acid as an active ingredient is more widely distributed under other names. If your country is not on this list, a local pharmacist can usually confirm what is available regionally.

Are there other medications with the same active ingredient as Ponstan forte?

Mefenamic acid is sold under several brand names worldwide and is also widely available as a generic in markets where the original patent has long expired. The broader nonsteroidal anti-inflammatory class is represented internationally by a number of other molecules, although they are not freely interchangeable. To identify a local product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.

Should I consult a doctor before taking Ponstan forte?

Yes. Nonsteroidal anti-inflammatory therapy is calibrated to a patient's overall health, concurrent medications, and individual circumstances, and prescription rules vary across the countries where Ponstan forte is registered — in some markets mefenamic acid is prescription-only, in others it is more readily accessible. Travellers and expatriates managing recurrent pain should treat any change of brand or molecule as a conversation with a healthcare provider.

Ponstan forte

Available in 7 countries