STIRLESCENT

4). Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis The recommended dose is 250 mg, twice daily. Adjust to 500 mg to 1000 mg daily in two divided doses at 12-hour intervals. Acute gout The recommended dose is 750 mg initially, followed by 250 mg every 8 hours, until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea The recommended dose is 500 mg initially, followed by 250 mg at 6 to 8 hours intervals as needed, with a maximum daily dose after the first day of 1250 mg. Paediatric population Stirlescent is not recommended for use in children and adolescents under 18 years of age because the correct dose cannot be administered using this formulation.

Elderly Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The implication of this finding for Stirlescent dosing is unknown. 4). Increased risk of serious consequences of adverse reactions.

If NSAID use is considered necessary, the lowest effective dose should be used for the shortest possible duration. Monitor regularly for GI bleeding during treatment. Renal/hepatic impairment Consider a lower dose in patients with renal or hepatic impairment.

3) has been seen in patients with severe renal failure or those on dialysis. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen. Method of administration For oral administration. Doses of 1 to 2 tablets must be dissolved in at least 150 ml (a glass) of water, doses of 3 tablets must be dissolved in 300 ml.

The glass should be rinsed with a small amount of water (10 ml) and the contents drunk. To be taken preferably with or after food.

The following adverse events have been reported with NSAIDs and naproxen:

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. 4). 4), pancreatitis and gastritis have been reported following administration.

Immune system disorders:

Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with or without a history of previous hypersensitivity reactions to 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 and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiac disorders:

Oedema, palpitations, congestive heart failure, hypertension and cardiac failure have been reported in association with NSAID treatment. 4).

Renal and urinary disorders:

Nephrotoxicity in various forms, including glomerulonephritis, haematuria, raised serum creatinine, renal papillary necrosis, interstitial nephritis, nephrotic syndrome and renal failure.

Hepatobiliary disorders:

Abnormal liver function tests, hepatitis (including fatal hepatitis) and jaundice. 4).

Blood and lymphatic system disorders:

Thrombocytopenia, neutropenia, granulocytopenia including agranulocytosis, aplastic anaemia, eosinophilia, leucopoenia and haemolytic anaemia.

2, and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events. 5).

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal In the elderly the clearance is reduced. 2). Prolonged use of NSAIDs in the elderly is not recommended.

Where prolonged therapy is required, patients should be reviewed regularly.

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 coxibs and 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).

Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Stirlescent 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.

Active or a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). 1. g. asthma, rhinitis, nasal polyps or urticaria) in response to ibuprofen, aspirin, or other NSAIDs.

These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4). 6).