Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage:** The recommended starting dose of naproxen sodium for adults is two 275 mg tablets followed by one 275 mg tablet every 6 to 8 hours, as required. The total daily dose should not exceed 5 tablets (1375 mg).
ORAL
Medical Information
**Indications:** For the relief of mild to moderately severe pain accompanied by inflammation in conditions such as musculoskeletal trauma and postdental extraction. Also indicated for the relief of pain associated with post partum cramping and dysmenorrhea.
**Contraindications:** Peptic ulcer or active inflammatory diseases of the gastrointestinal system. Known or suspected hypersensitivity to the drug. Naproxen sodium should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents. Fatal anaphylactoid reactions have occurred in such individuals.
M01AE02
naproxen
Manufacturer Information
PHARMAFORTE SINGAPORE PTE LTD
APOTEX INC
Active Ingredients
Documents
Package Inserts
1.4.3 Proposed clean PI - Apo-Napro-NA (20 Oct 2021).pdf
Approved: November 25, 2021