OPUSTAN

Posology Adults:

The usual dosage is 500mg 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, it has been used at normal dosage in trials which include many elderly patients. However, it should be used with caution in elderly patients suffering from dehydration and renal failure.

Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic acid after the development of diarrhoea. 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 Gl bleeding during NSAID therapy. Paediatric population (under the age of 12) Not Recommended. Method of administration For oral administration. To be taken preferably with or after food. 4).

General description The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract. Diarrhoea appears to be the most common side effect and is usually dose-related. It generally subsides on dosage reduction, and rapidly disappears on termination of therapy.

Some patients may not be able to continue therapy. Adverse reactions are listed below according to system organ class and frequency.

Frequencies are defined according to the following convention:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data) Blood and the lymphatic system disorders: Frequency not known: Haemolytic anaemia†, anaemia, hypoplasia bone marrow, haematocrit decreased, thrombocytopenic purpura, leukopenia with a risk of infection, sepsis, disseminated intravascular coagulation, agranulocytosis, aplastic anaemia, eosinophilia, neutropenia, pancytopenia, thrombocytopenia.

† Haemolytic anaemia reversible when mefenamic acid is stopped. Reports are associated with 12 months of mefenamic acid therapy.

Immune system disorders:

Frequency not known: Hypersensitivity†, fixed drug eruption † Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity or (c) assorted skin disorders Metabolism and nutrition disorders: Frequency not known: Glucose intolerance impaired†, hyponatraemia.

† in diabetic patients Psychiatric disorders: Frequency not known: Confusion, depression, hallucinations, nervousness.

Nervous system disorders:

Frequency not known: Optic neuritis, headaches, paraesthesia, dizziness, drowsiness, meningitis aseptic†, blurred vision, convulsions, insomnia. 4).

Eye disorders:

Frequency not known: Eye irritation, colour blindness, visual impairment.

Ear and labyrinth disorders:

Frequency not known: Ear pain, tinnitus, vertigo. 4) Respiratory, thoracic and mediastinal disorders: Frequency not known: Asthma, dyspnoea. 4), gastritis, anorexia nervosa, enterocolitis, pancreatitis and steatorrhea. 4). 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.

††† 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.

Hepatobiliary disorders:

Frequency not known: liver function test abnormal, jaundice cholestatic, hepatotoxicity, hepatitis, hepatorenal syndrome.

Skin and subcutaneous tissue disorders:

Frequency not known: Angioedema, laryngeal oedema, erythema multiforme, face oedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, rash, photosensitivity reaction, pruritus and urticaria.

Renal and urinary disorders:

Frequency not known: glomerulonephritis, Tubulointerstitial nephritis , dysuria, haematuria, nephrotic syndrome, acute renal failure†, proteinuria, renal failure including renal papillary necrosis. † Non oliguric renal failure particularly in dehydration.

Renal toxicity has been seen in patients with pre-renal conditions leading to a reduction in renal blood flow or blood volume. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly.

General disorders and administration site conditions:

Frequency not known: Fatigue, malaise, multi-organ failure, pyrexia, hyperhydrosis.

Investigations:

Frequency not known: Total bile acids increased† † 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.

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).

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 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 These patients should commence treatment on the lowest dose available. 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). 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 the 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 the patient should not receive mefenamic acid again.

8). 8). Patients appear to be at high risk for 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 discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Blood dyscrasias Blood dyscrasias have been reported in association with mefenamic acid. Blood studies should be carried out […]

1. g. asthma, bronchospasm, rhinitis, angioedema or urticaria) to these medicines. Mefenamic acid is also contra-indicated in patients with inflammatory bowel disease, intestinal ulceration and 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). 6). Treatment of pain after coronary artery bypass graft (CABG) surgery.