PANADOL EXTRA TAB 24/TAB

Indications

Approved Uses

Short-term relief of mild to moderate pain (e.g., headache including migraine, dental pain, backache, muscular/rheumatic pain, neuralgia, dysmenorrhoea) and reduction of fever; may also relieve pain/fever associated with colds/flu/sore throat.

Dosage & Administration

Dosing by Condition

Pain/fever: Adults and adolescents: 1-2 tablets every 4-6 hours as needed; maximum 8 tablets in 24 hours; keep at least 4 hours between doses.

Initial Dose

1-2 tablets (500-1000mg paracetamol / 65-130mg caffeine)

Maintenance Dose

1-2 tablets every 4-6 hours as needed

Maximum Dose

Adults (16 years and over): 8 tablets (4000mg paracetamol/520mg caffeine) in 24 hours. Children (12-15 years): 4 tablets (2000mg paracetamol/260mg caffeine) in 24 hours.

Children's Dosage

Not recommended for children under 12 years.

Dose Adjustment Notes

Use caution in hepatic impairment, chronic alcohol use, malnutrition/low body weight, or dehydration and consider a reduced maximum daily paracetamol dose; in severe renal impairment extend the dosing interval (e.g., at least 6-8 hours).

Side Effects

Common Side Effects

Caffeine-related: insomnia/sleep disturbance, nervousness/restlessness/irritability, palpitations/tachycardia; gastrointestinal upset (nausea, dyspepsia/abdominal discomfort). Hypersensitivity reactions such as rash are rare.

Side Effect Frequency

Common/possible: gastrointestinal upset (nausea, dyspepsia/abdominal discomfort) and caffeine-related effects (insomnia/sleep disturbance, nervousness/restlessness/irritability, palpitations/tachycardia), especially with higher caffeine intake. Rare: hypersensitivity reactions (e.g., rash/urticaria). Very rare: serious skin reactions (e.g., SJS/TEN) and blood dyscrasias (e.g., thrombocytopenia). Hepatotoxicity is primarily associated with overdose or chronic excessive dosing rather than expected at recommended doses.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen), caffeine, or any excipients; concomitant use with other paracetamol-containing products

Warnings & Precautions

Do not exceed the recommended dose; do not use with other paracetamol-containing products; avoid/limit other caffeine sources; use with caution in hepatic disease, chronic alcohol use, and renal impairment; seek medical advice if symptoms persist or if taking interacting medicines (e.g., warfarin) or if severe liver/kidney disease is present

Age Restriction

Not recommended for children under 12 years.

Drug Interactions

Drug Interactions

Warfarin/coumarins (enhanced anticoagulant effect with regular/prolonged paracetamol use); enzyme inducers (e.g., carbamazepine, phenytoin, rifampicin) and chronic alcohol (↑ hepatotoxicity risk); cholestyramine (↓ paracetamol absorption if given close); metoclopramide/domperidone (↑ absorption rate); flucloxacillin (risk of high anion gap metabolic acidosis, especially with risk factors); caffeine interactions with other stimulants and some quinolones (reduced caffeine clearance)

Interaction Severity

MAJOR: Concomitant use with other paracetamol-containing products (overdose/hepatotoxicity risk). MODERATE: Warfarin/coumarins with regular repeated paracetamol use (↑INR/bleeding risk); enzyme inducers (e.g., carbamazepine, phenytoin, rifampicin) or isoniazid and chronic alcohol (↑hepatotoxicity risk); flucloxacillin (rare high anion gap metabolic acidosis, especially with risk factors); fluoroquinolones (e.g., ciprofloxacin) may increase caffeine effects. MINOR: Metoclopramide/domperidone (faster absorption); cholestyramine (reduced absorption if taken close together).

Food Interaction

May be taken with or without food; limit additional caffeine intake (coffee/tea/energy drinks) to reduce insomnia, nervousness, and palpitations.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Caution

Breastfeeding

Safe during breastfeeding

Children

Not recommended for children under 12 years.

Liver Impairment

Use with caution; avoid in severe hepatic impairment/active liver disease and in chronic heavy alcohol use; if mild-moderate impairment, use the lowest effective dose with longer dosing intervals and do not exceed the maximum daily dose

Storage & Patient Advice

Overdose

Paracetamol overdose may cause early nausea/vomiting/abdominal pain with potentially delayed severe hepatotoxicity (24-72 h); caffeine overdose may cause GI upset, agitation/insomnia, tremor, tachycardia and seizures; seek urgent medical care immediately even if asymptomatic and treat paracetamol toxicity with prompt N-acetylcysteine per protocols (± activated charcoal if early)

Patient Counseling

Do not exceed 2 tablets per dose or 8 tablets in 24 hours; keep at least 4 hours between doses. Do not use with any other paracetamol-containing product. Limit other caffeine sources and avoid taking near bedtime if it causes insomnia. Avoid or minimize alcohol and seek advice if liver disease, chronic alcohol use, low body weight/malnutrition, or severe renal disease. If symptoms persist or worsen (e.g., >3 days for fever or ongoing pain), consult a clinician; seek urgent help after overdose even if well.

Monitoring Requirements

No routine monitoring for short-term OTC use; liver function tests recommended with prolonged use or in at-risk patients

Pharmacology

Mechanism of Action

Paracetamol provides analgesic and antipyretic effects primarily via central inhibition of prostaglandin-mediated pathways and modulation of descending inhibitory pathways; caffeine is an adenosine receptor antagonist CNS stimulant that can enhance analgesia (and may modestly speed/augment effect).

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours

Half-Life

Paracetamol: 1.5-2.5 hours. Caffeine: approximately 3-5 hours.

Bioavailability

Paracetamol: high oral bioavailability (commonly ~70-90%, often cited ~80-90%). Caffeine: rapid and essentially complete absorption (≈100%).

Metabolism

Paracetamol: hepatic metabolism mainly by glucuronidation and sulfation, with a minor pathway via CYP2E1 (also CYP1A2/3A4) producing NAPQI. Caffeine: hepatic metabolism primarily via CYP1A2 to paraxanthine (major), theobromine, and theophylline.

Excretion

Paracetamol: primarily renal excretion of metabolites (glucuronide and sulfate conjugates), with <5% excreted unchanged in urine. Caffeine: primarily renal excretion as metabolites, with only a small fraction (~1-3%) excreted unchanged.

Protein Binding

Paracetamol: low protein binding (~10-25% at therapeutic concentrations; increases in overdose). Caffeine: moderate protein binding (~10-35%).

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: Paracetamol 500mg + Caffeine 65mg (as caffeine citrate equivalent)

Generic Availability

Yes

OTC Alternatives

Paracetamol alone (e.g., Panadol 500 mg), ibuprofen, or aspirin (if appropriate and no contraindications).

Pain Type

General

Nsaid

No

Opioid

No

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