API

Caffeine (50mg) + Paracetamol (650mg)

Drug classification

Analgesic and antipyretic combination; specific subclass: non-opioid analgesic with CNS stimulant.

Dosage form

Oral tablet containing caffeine 50mg and paracetamol 650mg.

API strength per dosage

Dose

Novalgin NU Tablet is typically dosed in adults as 1 tablet every 4–6 hours as needed, not exceeding 4 g paracetamol daily. Use in children is not established for this formulation. In renal or hepatic impairment, use with caution and consider dose reduction or increased dosing interval. Always follow local guidelines and consult a healthcare professional.

Mechanism of action

Paracetamol inhibits central cyclooxygenase (COX), reducing prostaglandin synthesis and thus pain and fever. Caffeine antagonizes adenosine receptors (mainly A1 and A2A) in the CNS, promoting alertness and enhancing analgesic efficacy. Together, they provide synergistic analgesia and improved pain relief.

Indications

Treatment of Headache

Side effects

Insomnia difficulty in sleeping Nervousness Irritation Restlessness

Pregnancy category

Paracetamol is generally considered safe in pregnancy when used as directed; caffeine should be limited due to potential risks with high intake. Consult your doctor.

Precautions

Monitor for hypersensitivity reactions, liver dysfunction, gastrointestinal irritation, avoid exceeding recommended paracetamol dose, caution in hepatic or renal impairment, avoid with other paracetamol-containing products, monitor for caffeine-related insomnia or palpitations, use cautiously in pregnancy and lactation, assess for drug interactions, avoid chronic use without medical supervision.

Contraindications

Hypersensitivity to paracetamol, caffeine, or excipients; severe hepatic impairment; severe renal impairment; active alcoholism; glucose-6-phosphate dehydrogenase deficiency; severe hypertension; arrhythmias; peptic ulcer disease; pregnancy and lactation unless clearly needed.