NAPROXEN EC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NAPROXEN

Available from:

Olinka (UK) Limited

Dosage:

250 Milligram

Pharmaceutical form:

Tablets

Authorization date:

1991-12-16

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naproxen E.C. 250mg Tablets 
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Naproxen Ph. Eur. 250 mg
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Naproxen E.C. 250mg Tablets: White, circular, biconvex, coated
tablet embossed with the identifying marking “N250”.
Diameter 10mm.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
For the management of various arthritides, such as rheumatoid
arthritis, osteoarthritis, spondylitis, gout, etc., and of 
musculoskeletal disorders.
For the management of juvenile polyarthritis and rheumatoid
arthritis in children over the 
age of five years.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration. Tablets should be swallowed whole and
not broken or crushed.
Adults:
The usual dose is 250 mg twice daily, with a maximum daily
dose of 1000 mg.
In the case of gout a dose of 750 mg may be required as an
initial dose given once, with 250 mg every eight hours 
thereafter for a maximum of 72 hours. Subsequently use may
be made of the usual regimen if necessary.
Children over the age of 5 years:
The usual total daily dose is 10 mg/kg b.w. in divided
doses every 12 hours.
The safety of the drug in children under the age of 5
years has not been demonstrated and
its use therefore cannot be 
recommended in this group.
4.3 CONTRAINDICATIONS
1. Use in patients with peptic ulcer disease,
active peptic ulceration or intestinal inflammatory disease.
2. Use in patients hypersensitive to naproxen
or other non-steroidal anti-inflammatory agents including aspirin.
3. Use in children under 16
years of age except for juvenile rheumatoid arthritis.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 10/11/2005_
_CRN 2016697_
_page number: 1_
4.