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PONSTAN FORTE is a brand name for Mefenamate (also known as Mefenamic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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),…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Do not exceed the stated dose. Posology Adults 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.
Elderly (over 65 years) 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. Paediatric population It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50 mg/5ml).
Method of administration For oral administration. Ponstan Forte tablets should be taken preferably with or after food.
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 If diarrhoea does develop the drug should be withdrawn immediately and this patient should not receive mefenamic acid again.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 nutrition disorders Glucose intolerance in diabetic patients, hyponatraemia. Psychiatric disorders Confusion, depression, hallucinations, nervousness. 4). Blurred vision, convulsions, insomnia. Eye disorders Eye irritation, reversible loss of colour vision, visual disturbances.
2 and GI and cardiovascular risks below). Patients on prolonged therapy should be kept under regular surveillance with particular attention to liver dysfunction, rash, blood dyscrasias or development of diarrhoea. 8). 5). Prolonged use of any type of painkiller for headaches can make them worse.
If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of ‘Medication Overuse Headache’ should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Precaution should be taken in patients suffering from dehydration and renal disease, particularly the elderly. 2).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Cardiovascular, renal and hepatic impairment:
The administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3).
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
1. - Inflammatory bowel disease - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. - Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
4). g. asthma, bronchospasm, rhinitis, angioedema or urticaria) to these medicines. 6). - Treatment of pain after coronary artery bypass graft (CABG) surgery.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ear and labyrinth disorders Ear pain, tinnitus, vertigo. Cardiac / Vascular disorders Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). Palpitations. Hypotension. Respiratory, thoracic and mediastinal disorders Asthma, dyspnoea.
Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. 4). 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. Hepatobiliary 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 and administration site conditions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are insufficient data to exclude such a risk for mefenamic acid. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with mefenamic acid after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). As NSAIDs can interfere with platelet function, they should be used in caution in patients with intracranial haemorrhage and bleeding diathesis.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Smoking and alcohol use are added risk factors.
3), and in the elderly. g. 5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 5). When GI bleeding or ulceration occurs in patients receiving mefenamic acid the treatment should be withdrawn.
8). 8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Mefenamic acid should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Female fertility:
The use of mefenamic acid may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of mefenamic acid should be considered.
In dysmenorrhoea and menorrhagia lack of response should alert the physician to investigate other causes.
Epilepsy:
Caution should be exercised when treating patients suffering from epilepsy. 2).
Alcohol:
Concomitant consumption of alcohol with […]