NAPROXEN

4). Adults Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis 500mg to 1g taken in 2 doses at 12 hour intervals, or alternatively, as a single administration. In the following cases a loading dose of 750mg or 1g per day for the acute phase is recommended: a) In patients reporting severe night time pain/ or morning stiffness.

b) In patients being switched to naproxen from a high dose of another antirheumatic compound. c) In osteoarthritis where pain is the predominant symptom. Acute gout Initially 750mg at once then 250mg every 8 hours until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea 500mg initially followed by 250mg at 6-8 hour intervals as needed, with a maximum daily dose after the first day of 1250mg. 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 naproxen dosing is unknown. As with other drugs used in the elderly it is prudent to use the lowest effective dose and for the shortest duration possible as elderly patients are at increased risk of the serious consequences of adverse reactions.

The patient should be monitored regularly for GI bleeding during NSAID therapy. For the effect of reduced elimination in elderly patients refer to section

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. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

g. 4) General disorders and administration site complications fatigue, mild peripheral oedema, pyrexia *especially in patients with existing auto-immune disorders, such as system lupus erythematosus, mixed connective tissue disease, with symptoms such as stiff neck headache, nausea, vomiting, fever and disorientation.

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.

4. Dosage should be reduced in the elderly where there is an impairment of renal function. (see section 4). Paediatric population (over 5 years) For juvenile rheumatoid arthritis 10mg/kg/day taken in 2 doses at 12 hour intervals. Renal/ hepatic impairment A lower dose should be considered in patients with renal or hepatic impairment.

3). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Method of administration For oral administration. Tablets should be swallowed whole and not broken or crushed. To be taken preferably with or after food.

3 Contraindications Patients with active gastrointestinal bleeding or peptic ulceration, known hypersensitivity to naproxen, naproxen sodium or any other ingredient in the formulation. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. 4). 6) History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 2 and GI and cardiovascular risks below).

Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events. Elderly and/ or debilitated patients Elderly patients and/or debilitated patients are particularly susceptible to the adverse effects of NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly. The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.

Mild peripheral oedema has been observed in a few patients receiving naproxen. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking naproxen.

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) - in the elderly - when used with alcohol - in smoking.

These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly the 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 naproxen, the treatment should be withdrawn. 8). Renal effects There have been reports of impaired renal function, renal failure, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen.

8). Acute tubulointerstitial nephritis can progress to renal failure. Naproxen should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated. Renal failure linked to reduced prostaglandin production – 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, angiotensin converting enzyme inhibitors, angiotensin-II receptor antagonists and the elderly.

3). Use in patients with impaired renal function As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised and patients should be adequately hydrated.

Naproxen is contraindicated in patients having baseline creatinine clearance of less than 30ml/minute. Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree […]

Patients with active gastrointestinal bleeding or peptic ulceration, known hypersensitivity to naproxen, naproxen sodium or any other ingredient in the formulation. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. 4). 6) History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.