NABUMETONE

Method of Administration:

For oral administration. 4). Nabumetone 500 mg film-coated tablets should be taken preferably with or after food.

Posology:

Adults: 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 tablets (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 1 g should not be exceeded in this age group and in some cases 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 population:

There are no clinical data to recommend use of Nabumetone 500mg Tablets in children.

4). Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), 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 know (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.

4)), vertigo, drowsiness Eye disorders Uncommon: Abnormal vision, eye disorders Not known: Optic neuritis Ear and labyrinth disorders Common: Tinnitus, ear disorder Vascular disorders Common: Increases in blood pressure Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, respiratory disorder, epistaxis Very rare: Interstitial pneumonitis Not known: Asthma, aggravated asthma, bronchospasm Gastrointestinal disorders Common: Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence Uncommon: Duodenal ulcer, GI bleeding, gastric ulcer, GI disorder, melaena, vomiting, stomatitis, dry mouth Very rare: Pancreatitis Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature.

4). 4) have been reported following administration. Less frequently, gastritis has been reported.

Hepatobiliary disorders Very rare:

Hepatic failure, jaundice Skin and subcutaneous tissue disorders 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 Not known: Purpura Musculoskeletal and connective tissue disorders Uncommon: Myopathy Renal and urinary disorders Uncommon: Urinary tract disorder Very rare: Renal failure, nephrotic syndrome Not known: Interstitial nephritis Reproductive system and breast disorders Very rare: Menorrhagia General disorders and administration site conditions Common: Oedema Uncommon: Asthenia, fatigue Not known: Malaise Investigations Uncommon: Elevated liver function tests Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

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.

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 toxicity/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 patient’s 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.

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 , 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