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Stirlescent® (naproxen) 250mg effervescent tablets
This information provides a brief summary about Stirlescent® 250mg effervescent tablets. Each tablet contains 250mg of naproxen sodium. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) and Stirlescent® is licensed for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, dysmenorrhoea and acute musculoskeletal conditions in adults.
Stirlescent® 250mg effervescent tablets (blackcurrant flavour) offer a lower cost option for treatment with naproxen in patients who may experience swallowing difficulties and who require a liquid form of NSAID. The product is the only licensed effervescent tablet formulation that is currently available. The only other option that exists is liquid ‘specials’ formulations that are not licensed and are costly due to the requirement for limited batch production. More recently a licensed liquid formulation of naproxen 125mg/5ml has been marketed. The cost of this product is in line with that of the ‘specials’ formulations.
Key Facts –
- Licensed in the UK as of 3rd December 2015
- Effervescent formulation that disperses in water to form a suspension
- Blackcurrant flavouring
- 341.89mg sodium content in each tablet
- Tablets are sugar free with saccharin sodium and mannitol being used as artificial sweetening agents.
- Indicated in adults and adolescents aged 18 years and over for the treatment of pain and inflammation due to rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal conditions, gout and dysmenorrhoea.
- NHS list price is £52.72 for a pack of 20 tablets
- Each tablet contains 250mg of naproxen. Each tablet also contains 341.89 mg of sodium and the following excipients – anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sodium cyclamate, saccharin sodium, sodium citrate, povidone K30, macrogol 6000, mannitol, simeticone, docusate sodium and flavour Cassis ‘NAP’, code 410.
- Indications: For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout.
- Dosage and administration – Adults and adolescents aged 18 years and over.
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: Initially 250mg twice daily, increasing if necessary to 500mg twice daily. Stirlescent® is not licensed for use in the paediatric age group as it may not be possible to administer the correct dose with this formulation.
- Acute musculoskeletal conditions and dysmenorrhoea: Initial dose of 500mg followed by 250mg every 6 – 8 hours. Maximum dose after the first day is 5 tablets daily. For this indication – Not licensed for use in children and adolescents under 18 years of age.
- Acute gout: Initial dose of 750mg followed by 250mg every 8 hours until the attack has passed.
- Elderly patients: Due to possible reduced elimination in the elderly and an increased risk of adverse reactions it is recommended to use the lowest effective dose for the shortest possible duration. Regular review of the patient is essential taking particular note of any GI bleeding. Discontinue treatment if there is no benefit or intolerable side effects.
- Renal/Hepatic impairment: Consider lowering the dose in patients with renal or hepatic impairment. Stirlescent® is contraindicated if the renal creatinine clearance is less than 30ml/min.
- Method of Administration: Doses of 1 to 2 tablets must be dissolved in at least 150ml (a glass) of water and doses of 3 to 4 tablets must be dissolved in 300ml of water. As this forms a suspension it is important that the glass is rinsed with a small amount of water and the contents drunk.
- Preferably to be taken with or after food.
- Legal category: POM
- Pack size: 20 effervescent tablets in polypropylene tubes with desiccant included in the stopper.
- Shelf life: 36 months
- NHS list price: 20 effervescent tablets – £52.72
- Storage: There are no special storage requirements for these tablets
- Marketing Authorisation Holder: Stirling Anglian Pharmaceuticals Ltd, Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United Kingdom.
- Marketing Authorisation Number: PL42582/0009
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also be reported to JensonR+ on 01271 314320 or Stirling Anglian Pharmaceuticals Ltd on 0141 585 6352