STIRLESCENT Effervescent tablet Ref.[49974] Active ingredients: Naproxen

Posology

Use of the lowest effective dose for the shortest duration necessary to control symptoms is recommended, in order to minimise undesirable effects (see section 4.4).

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

Start at 250 mg, twice daily. Adjust to 500 mg to 1000 mg daily in two divided doses.

Acute gout

Start at 750 mg, followed by 250 mg every 8 hours.

Acute musculoskeletal disorders and dysmenorrhoea

Start at 500 mg, followed by 250 mg every 6 to 8 hours.

Paediatric population

Stirlescent should not be used in the paediatric population because the correct dose cannot be administered using this formulation.

Elderly

Reduced elimination in the elderly (see section 4.4). 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. Review treatment at regular intervals and discontinue if no benefit is seen, or if intolerance occurs.

Renal/hepatic impairment

Consider a lower dose in patients with renal or hepatic impairment. Contraindicated in patients with baseline creatinine clearance less than 30 ml/minute due to potential accumulation of naproxen metabolites (see section 4.3).

Method of administration

Oral.

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.

Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measure

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.

36 months.

This medicinal product does not require any special storage conditions.

Polypropylene tube with polyethylene desiccant stopper or laminated aluminium paper foil.

Pack sizes: 10, 12, 15, 20, 24 and 30 effervescent tablets.

Not all pack sizes may be marketed.

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