NAPROXEN Tablet Ref.[6417] Active ingredients: Naproxen

Posology

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Method of administration

For oral administration.

To be taken preferably with or after food

Rheumatic arthritis, osteoarthritis and ankylosing spondylitis (Adults)

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:

• In patients reporting severe night-time pain/or morning stiffness.
• In patients being switched to Naprosyn from a high dose of another anti-rheumatic compound.
• In osteoarthrosis where pain is the predominant symptom.

Acute Gout (Adults)

In acute gout an initial dose of 750 mg followed by 250mg every 8 hours until attack has passed; has been suggested.

Musculoskeletal Disorders and Dysmenorrhoea (Adults)

500mg may be given initially followed by 250mg every 6 to 8 hours as required. Maximum daily dose after first day is 1250mg daily.

Older people

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in older people. The implication of this finding for Naprosyn dosing is unknown. As with other drugs used in older people it is prudent to use the lowest effective dose and for the shortest duration possible as older people 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 older people refer to Section 4.4.

Pediatric population (over 5 years)

For juvenile rheumatoid arthritis

A dose of 10mg per kg body weight daily in two divided doses at 12-hour intervals has been used in children over 5 years of age. Naproxen tablets are not recommended for use in any other indication in children under 16 years of age.

Renal/hepatic impairment

A lower dose should be considered in patients with renal or hepatic impairment. Naprosyn is contraindicated in patients with baseline creatinine clearance less than 30 ml/minute because accumulation of naproxen metabolites has been seen in patients with severe renal failure or those on dialysis (see section 4.3).

Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Symptoms

Symptoms include headache, nausea , vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, heartburn, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions, transient changes in liver function, hypothrombinemia, apnea and metabolic acidosis. In cases of significant poisoning acute renal failure and liver damage are possible.

Management

Patients should be treated symptomatically as required.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient’s clinical condition.

Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding. However, haemodialysis may still be appropriate in a patient with renal failure who has taken naproxen.

Shelf life

Opaque containers: 3 years.

Blister Packs: 3 years.

Containers: Do not store above 25°C. Store in the original container.

Blister pack: Do not store above 25°C. Keep container in the outer carton.

White polypropylene containers with LDPE closure having tamper evident seal: 1000, 500, 250, 100, 84,70, 56,42, 28, 21, 15 and 14 tablets.

Blister Strips (composed of PVC film and aluminium foil): 84, 70, 56, 42, 28, 21, 15 and 14 tablets.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.