NAPROXEN ENTERIC COATED

For oral administration. Naproxen EC tablets should be swallowed whole and not broken or crushed. Adults For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis the usual dose is 500mg to 1g daily, taken in two divided doses.

In the case of gout a dose of 750mg may be required as an initial dose given once, with 250mg every eight hours until the attack has passed. For dysmenorrhoea and acute musculo-skeletal disorders the usual initial dose is 500mg and thereafter 250mg every 6 to 8 hours.

Elderly persons 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.

Children over the age of 5 years In the treatment of juvenile rheumatoid arthritis, in children over 5 years of age, the usual dose is 10mg/kg/day divided into two doses taken at 12 hour intervals. The safety of Naproxen EC tablets in children under 5 years of age has not been established and therefore use is not recommended.

4).

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature. 4). 4 Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.

Hypersensitivity:

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, eosinophilic pneumonitis, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema, alopecia and more rarely exfoliative, porphyria cutanea tarda and bullous dermatoses (including epidermal necrolysis, erythema multiforme and Stevens-Johnson syndrome).

Cardiovascular:

Oedema, hypertension, cardiac failure and rarely vasculitis have been reported in association with NSAID treatment. 4). Although data suggest that the use of naproxen (1000 mg/d) may be associated with a lower risk, some risk cannot be excluded.

Other adverse events reported less commonly include:

Renal: Nephrotoxicity in various forms, including glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, papillary necrosis and renal failure.

Hepatic:

Abnormal liver function, hepatitis and jaundice. 4), depression, convulsion, confusion, hallucinations, hearing impairment, tinnitus, vertigo, dizziness, insomnia, malaise, fatigue, drowsiness, lack of concentration and cognitive dysfunction.

Haematological:

2, and GI and cardiovascular risks below). 2 – Posology and administration) Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma or allergic disease since NSAIDs have been reported to precipitate bronchospasm in such patients.

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 (particularly if long term dosage is under consideration), cardiac impairment, liver dysfunction, cirrhosis of the liver, sodium retention, those taking diuretics, the elderly and patient in whom renal blood flow is compromised such as in extra cellular fluid volume depletion.

3 – Contraindications). Use is not recommended in patients with a creatinine clearance of less than 20ml/min. 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 naproxen. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration.

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

1. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

4 – Special warnings and precautions for use). 6 – Pregnancy and lactation). Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors (See section