NABUMETONE

4). Nabumetone 500 mg film-coated Tablets should be taken preferably with or after food. Adult The recommended daily dose is two tablets (1 g) taken as a single dose at bedtime. For severe or persistent symptoms, or during acute exacerbations, an additional one or two tablet (500 mg-1 g) may be given as a morning dose.

Elderly In common with many drugs, blood levels may be higher in elderly patients. The recommended daily dose of two tablets (1 g) should not be exceeded in this age group and in some cases one tablet (500 mg) may give satisfactory relief.

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 patients should be monitored for gastrointestinal bleeding during NSAID therapy.

Paediatric There are no clinical data to recommend use of Nabumetone 500 mg film-coated Tablets in children. Method of administration For oral administration.

4). Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo and comparator groups has not been taken into account in estimation of these frequencies. Rare and very rare events were generally determined from spontaneous data.

MedRA System Organ Class Frequency Adverse Reaction Very Rare ThrombocytopeniaBlood and lymphatic system disorders Not known Neutropenia, agranulocytosis, leucopenia, aplastic anaemia and haemolytic anaemia. 4)), vertigo, drowsiness Uncommon Abnormal vision, eye disorderEye disorders Not known Optic neuritis Ear and labyrinth disorders Common Tinnitus, ear disorder Vascular disorders Common Increases in blood pressure Uncommon Dyspnoea, respiratory disorder, epistaxis Very rare Interstitial pneumonitis Respiratory, thoracic and mediastinal disorders Not known Asthma, aggravated asthma, bronchospasm Common Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence Uncommon Duodenal ulcer, Gl bleeding, gastric ulcer, Gl disorder, melena, vomiting, stomatitis, dry mouth Gastrointestinal disorders1 Very rare Pancreatitis Hepatobiliary disorders Very rare Hepatic failure, jaundice Common Rash, pruritus Uncommon Photosensitivity, urticaria, sweating Very rare Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia Skin and subcutaneous tissue disorders Not known Purpura Musculoskeletal and connective tissue disorders Uncommon Myopathy Uncommon Urinary tract disorder Very rare Renal failure, nephrotic syndrome Renal and urinary disorders Not known Interstitial nephritis Reproductive system and breast disorders Very rare Menorrhagia Common Oedema Uncommon Asthenia, fatigue General disorders and administration site conditions Not known Malaise Investigations Uncommon Elevated liver function tests 1Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature.

4). 4) have been reported following administration. Less frequently, gastritis has been observed. Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. 4). 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 gastrointestinal and cardiovascular risks below). 5). 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 dependent 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.

In patients with severe renal impairment (creatinine clearance less than 30 ml/minute): laboratory tests should be performed at baseline and within some weeks of starting therapy. Further tests should be carried out as necessary; if the impairment worsens, discontinuation of therapy may be warranted.

5). As with other NSAIDs, abnormalities of liver function tests, rare cases of jaundice and hepatic failure (some of them with fatal outcomes), have been reported. A patient with signs/symptoms suggesting liver dysfunction or who has experienced an abnormal liver function test while on nabumetone therapy should be evaluated for evidence of development of a more serious hepatic reaction.

Nabumetone should be discontinued if such a reaction occurs. Cardiovascular and cerebrovascular effects Appropriate monitoring and therapy should be instigated if warranted 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 nabumetone. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with nabumetone after careful consideration.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). 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.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI peptic disease, particularly when elderly, should report any unusual abdominal symptoms indicative for ulceration (especially GI bleeding) particularly in the initial stages of treatment.

5). When GI bleeding or ulceration occurs in patients receiving nabumetone, the treatment should be withdrawn. 8). In patients with active peptic ulcer, physicians must weigh the benefits of therapy with nabumetone against possible hazards, institute an appropriate ulcer treatment regimen and monitor the patients' progress carefully.

Nabumetone is better tolerated than most other NSAIDs, primarily because it results in fewer effects on the gastrointestinal (GI) system. 8 %; although these figures are lower than those ascribed to other NSAIDs, the prescribing physician should be aware that these ADR can occur even in the absence of previous peptic disease.

Despite the relative gastrointestinal and renal safety of nabumetone, caution should be used when administering to patients with: - active upper GI ulceration. Appropriate treatment should be instigated prior to initiating nabumetone therapy.

- Previous acetylsalicylic acid, aspirin- or other NSAID-induced asthma, urticaria or other allergic type reactions. Since fatal asthma attacks have been reported in such patients receiving other NSAIDs, the first […]

1. • Active, or history of recurrent peptic ulcer / GI haemorrhage, perforation or peptic disease (two or more distinct episodes). g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. 4). 6). • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Patients with severe heart failure and in patients with current cerebrovascular or other haemorrhage.