PANADOL 500/MG TAB 24/TAB

Indications

Approved Uses

Temporary relief of mild to moderate pain (e.g., headache, toothache, backache, musculoskeletal aches, dysmenorrhea, sore throat/cold & flu aches) and reduction of fever.

Off-Label Uses

No specific off-label uses should be asserted for this OTC product; clinically it is sometimes used as an analgesic option in osteoarthritis when NSAIDs are unsuitable, but this is not product-specific labeling.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years (pain/fever): 500-1000 mg every 4-6 hours as needed; maximum 4000 mg in 24 hours (and avoid exceeding label limits).

Initial Dose

500mg-1000mg as a single dose

Maintenance Dose

500mg-1000mg every 4-6 hours as needed

Maximum Dose

4000mg per 24 hours in healthy adults; 2000mg per 24 hours in patients with hepatic impairment or chronic alcohol use

Dose Adjustment Notes

Hepatic impairment/chronic alcohol use/malnutrition: use the lowest effective dose and reduce maximum daily dose; severe hepatic disease-avoid or use only with medical supervision. Renal impairment: extend dosing interval when CrCl <30 mL/min (e.g., every 6-8 hours).

How to Take

Dissolve the tablet(s) completely in a full glass of water and drink immediately; may be taken with or without food.

How to Prepare

If this is the SFDA-registered PANADOL SOLUBLE 500 mg tablet: dissolve the tablet completely in a full glass of water and drink once effervescence has stopped; if it is a standard swallow tablet, no preparation is required (swallow with water).

Side Effects

Common Side Effects

Rare: rash, hypersensitivity reactions. Very rare: hepatic dysfunction, thrombocytopenia.

Safety & Warnings

Warnings & Precautions

Do not exceed recommended dose or maximum daily limit; avoid concurrent use with other paracetamol/acetaminophen-containing products; use caution and consider lower max daily dose in liver disease, chronic alcohol use, malnutrition/low body weight, dehydration; use caution in severe renal impairment (extend dosing interval); stop and seek care if rash or hypersensitivity occurs; avoid prolonged continuous use without medical advice.

Age Restriction

Adults and children ≥12 years: use standard 500 mg tablet dosing; for children <12 years, this 500 mg tablet strength is generally not recommended-use age/weight-appropriate pediatric paracetamol formulations (e.g., liquid/low-dose) per local labeling.

Driving Warning

Safe

Drug Interactions

Interaction Severity

MAJOR: Excess/chronic alcohol use (increased hepatotoxicity risk). MODERATE: Warfarin (regular, repeated paracetamol use can increase INR). MODERATE: Enzyme inducers/other hepatotoxins (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, isoniazid) increase hepatotoxicity risk. MINOR: Metoclopramide (faster absorption), cholestyramine (reduced absorption if close together).

Special Populations

Breastfeeding

Safe

Elderly

Standard adult dosing; maximum daily dose 3000-4000mg.

Liver Impairment

Hepatic impairment: use with caution; in cirrhosis/chronic liver disease or chronic alcohol use, reduce maximum total daily dose to 2-3 g/day (often 2 g/day in higher-risk patients) and avoid prolonged high-dose use; severe hepatic impairment/active severe liver disease: avoid or only under specialist supervision.

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep in a dry place away from light. Keep out of reach of children.

Preparation Instructions

If this is the SFDA-registered PANADOL SOLUBLE 500 mg tablet: dissolve the tablet completely in a full glass of water and drink once effervescence has stopped; if it is a standard swallow tablet, no preparation is required (swallow with water).

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose

Stopping the Medicine

Safe to stop anytime; no tapering required.

Overdose

Overdose may be initially asymptomatic or cause nausea/vomiting/abdominal pain; serious hepatotoxicity can be delayed (typically 24-72 hours) progressing to jaundice, coagulopathy, hepatic failure; management is urgent medical assessment, consider activated charcoal if within ~1 hour of a significant ingestion, and give N-acetylcysteine (NAC) as early as possible guided by nomogram/clinical protocol with monitoring/supportive care.

Monitoring Requirements

No routine monitoring required at therapeutic doses; liver function tests recommended with prolonged use or in patients with hepatic risk factors

Pharmacology

Mechanism of Action

Analgesic/antipyretic action primarily via central inhibition of prostaglandin synthesis (COX activity) and modulation of central pain pathways; antipyresis via hypothalamic heat-regulating center.

Duration of Effect

4-6 hours.

Metabolism

Hepatic metabolism mainly via glucuronidation and sulfation; a minor pathway via CYP2E1 (and other CYPs) forms NAPQI, detoxified by glutathione.

Product Information

Available Dosage Forms

Tablet, soluble/effervescent tablet, caplet, oral suspension, suppository, intravenous infusion

Composition per Dose

Each soluble tablet: 500mg Paracetamol

OTC Alternatives

Ibuprofen (NSAID) and aspirin (where appropriate; avoid in children/adolescents with viral illness and consider GI/bleeding risk).

Pain Type

General

Nsaid

No

Opioid

No

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