Naprofen 500 mg 20 tablets

Naprofen 500 mg 20 tablets

Composition

Each tablet contains:

Active substance: Naproxen – 500 mg

Excipient: Lactose monohydrate – 24.3 mg

For the full list of excipients, see section 6.1 of the leaflet.

Description

Naprofen (naproxen) is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory, and antipyretic properties. It inhibits the activity of the cyclooxygenase (COX) enzyme, reducing the production of prostaglandins, which are mediators of pain, inflammation, and fever. It is used to relieve pain, reduce inflammation, and lower fever in various rheumatic and non-rheumatic conditions.

Indications for Use

Rheumatoid arthritis

Osteoarthritis

Ankylosing spondylitis

Acute gout

Acute musculoskeletal disorders

Dysmenorrhoea

Juvenile rheumatoid arthritis (in children over 5 years old)

Dosage and Method of Administration

For adults:

-Rheumatic conditions: 500–1000 mg daily in two doses, preferably with food. Loading dose of 750–1000 mg/day may be used in severe cases.

-Acute gout: initial dose 750 mg, then 250 mg every 8 hours until symptoms resolve.

-Musculoskeletal pain/dysmenorrhoea: 500 mg initially, followed by 250 mg every 6–8 hours as needed (max 1250 mg/day after first day).

-Children over 5: 10 mg/kg/day in two divided doses for juvenile arthritis.

-Elderly: Use the lowest effective dose for the shortest possible time.

Contraindications

-Hypersensitivity to naproxen or other NSAIDs

-History of NSAID-induced bronchospasm, urticaria, or rhinitis

-Active or history of GI ulcers or bleeding

-Severe heart, liver, or kidney failure

-Third trimester of pregnancy

-Rectal or cerebrovascular bleeding

-Children under 5 years (under 16 for acute pain or gout)

Precautions

-Caution in elderly, patients with GI, liver, renal, or cardiovascular diseases

-Risk of serious GI complications; monitor closely

-May mask signs of infection

-Increased risk of bronchospasm in asthmatic patients

-Use with caution alongside anticoagulants, corticosteroids, SSRIs

Side Effects

GI: nausea, ulcers, bleeding

Allergic: rash, anaphylaxis

Hepatic/renal impairment

Headache, dizziness, bronchospasm

Elevated liver enzymes

Pregnancy and Breastfeeding

Contraindicated in the third trimester. Use with caution in the first and second trimesters. Not recommended during breastfeeding.

Storage Conditions

Store below 30°C in the original package. Protect from moisture and light.

Packaging

Carton contains 2 blisters of 10 tablets each and a package insert.