NYCOPREN

Posology Adult dosage:

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: 500 mg to 1 g per day 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 severe night-time pain and/or morning stiffness, b) In patients being switched to Naproxen from a high dose of another NSAID, c) In osteoarthrosis where pain is the predominant symptom.

Loading dose of 750 mg – 1 g per day during the acute phase. Acute gout 750 mg at once then 250 mg every 8 hours until the attack has passed. Acute inflammatory musculoskeletal disorders 500 mg initially, followed by 250 mg 6 - 8 hour in intervals as needed.

Maximum daily dose is 1250 mg.

Paediatric population (over 5 years) For juvenile rheumatoid arthritis:

A dose of 10 mg per kg body weight daily in two divided doses at 12 hour intervals taken in children over 5 years of age with juvenile rheumatoid arthritis. Naproxen is not recommended for use in any other indication in children under 16 years of age.

Use in the 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 older people 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

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

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress. 4), oesophagitis, gastritis and pancreatitis.

Blood and lymphatic disorders:

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

Immune system disorders:

Hypersensitivty 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 anaphylactic reactions to naproxen and naproxen sodium formulations (eosinophilic pneumonia may occur rarely) (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angio-oedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Metabolic and nutrition disorders:

Hyperkalaemia Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and hallucinations.

Nervous system disorders:

Convulsions, dizziness, headache, lightheadedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and cognitive dysfunction have been reported. 4).

4 For Naproxen Gastro-resistant Tablets, adult doses may be used but with caution (when high doses are required). Renal/hepatic impairment A lower dose should be considered in patients with renal or hepatic impairment. (See other special warnings and precautions).

4). 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.

• Active or history of recurrent peptic ulceration / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • NSAID’s contraindicated in patients who have p reviously shown hypersensitivity reactions, Naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria or other non-steroidal anti-inflammatory drugs.

These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4 – Special warnings and precautions for use). • A history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

6). 2, and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events. The use of Naproxen with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors should be avoided (See section

1. • Patients with active gastrointestinal bleeding. • Active or history of recurrent peptic ulceration / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • NSAID’s contraindicated in patients who have p reviously shown hypersensitivity reactions, Naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria or other non-steroidal anti-inflammatory drugs.

These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4 – Special warnings and precautions for use). • A history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

6).