Product Name & Strength: Clofenac 50 Tablet (Diclofenac Sodium 50 mg), 10 x 10's.
Indications (Approved Uses): Indicated for the relief of pain, inflammation, and swelling associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, muscular pain, dental pain, back pain, sciatica, menstrual cramps (dysmenorrhoea), post-surgical pain, and post-traumatic pain.
Contraindications (Safety Warnings): Contraindicated in patients with active peptic ulcers, gastrointestinal bleeding or perforation, severe renal or hepatic failure, and severe heart failure. Should be avoided by those with known hypersensitivity to diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin. Contraindicated during pregnancy, particularly in the third trimester. Use with caution in patients with cardiovascular risk factors, hypertension, or gastrointestinal disorders. Avoid concomitant use with anticoagulants, other NSAIDs, blood pressure medications, and alcohol, as these may increase the risk of side effects.
Side Effects (Adverse Reactions): Common side effects include stomach pain, nausea, indigestion, heartburn, acid reflux, headache, dizziness, and fluid retention (swelling in the hands or feet). Rare but serious complications may include gastrointestinal ulcers, gastrointestinal bleeding, liver or kidney dysfunction, and cardiovascular events.
Nutritional Information (per tablet): Diclofenac Sodium 50 mg.
Instructions for Use / Dosage: For oral administration. Adults: Take 50 mg two to three times daily, up to a maximum daily dose of 150 mg. Elderly: Take 50 mg one to two times daily, up to a maximum daily dose of 100 mg. Take with or after food to minimise the risk of stomach irritation. Swallow the tablet whole with water; do not crush or chew.
Regulatory Information: NAFDAC Registration Number: 04-3873. Manufactured by: Hovid Bhd, Malaysia.
