NAPROXEN

4). Adults Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis The usual dose is 500mg to 1g per day taken in two 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 The recommended dosage is 750mg at once then 250mg every eight hours until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea The recommended dosage is 500mg initially followed by 250mg at 6 to 8 hour intervals as needed, with a maximum of 1250mg daily after the first day. Loading dose As a single administration of two tablets, morning or evening, in the following cases a loading dose of 750mg -1g per day for the acute phase is recommended: 1.

In patients reporting severe night-time pain and / or morning stiffness. 2. In patients being switched to naproxen from a high dose of another antirheumatic compound. 3. In osteoarthrosis where pain is the predominant symptom. 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. If an NSAIDs is considered necessary, the lowest effective dose should be used and for the shortest duration possible as elderly patients are more prone to adverse events.

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

The following adverse events have been reported with NSAIDs and with naproxen. g. 4) General disorders and administration site complications fatigue mild peripheral oedema, pyrexia *especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease, with symptoms such as stiff neck headache, nausea, vomiting, fever and disorientation.

4). 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. 4). Children (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. To be taken preferably with or after food. 1 • Patients with active gastrointestinal bleeding or peptic ulceration • 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. • 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.

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.

1 • Patients with active gastrointestinal bleeding or peptic ulceration • 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.

• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 6)