EMIDOL 500/MG TAB 24/TAB

Indications

Approved Uses

Symptomatic relief of mild to moderate pain (e.g., headache, toothache, sore throat, dysmenorrhea, musculoskeletal/rheumatic pain, minor arthritis pain) and reduction of fever; may be used to relieve pain/fever associated with colds/flu.

Off-Label Uses

No specific off-label use is necessary to cite; common clinical uses include osteoarthritis pain and post‑immunization fever/pain, which are generally considered within standard analgesic/antipyretic use rather than true off-label indications.

Dosage & Administration

Dosing by Condition

Adults (pain/fever): 500-1000 mg orally every 4-6 hours as needed; maximum 4000 mg/day. Children: dose by weight (10-15 mg/kg per dose every 4-6 hours as needed; max 60 mg/kg/day and no more than 4 doses/24 h).

Initial Dose

500-1000mg as a single dose

Maintenance Dose

500mg to 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

Children's Dosage

Children 2-5 years: 120-250mg every 4-6 hours (max 4 doses/24h). Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24h). Dose by weight: 10-15mg/kg every 4-6 hours. Not recommended in children under 2 years without medical supervision

Dose Adjustment Notes

Renal impairment: extend dosing interval when CrCl <30 mL/min (e.g., dose every ≥6 hours); hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and consider a reduced maximum daily dose; avoid exceeding 4 g/day in adults and consider ≤3 g/day in older/frail patients per local guidance.

How to Take

Swallow the tablet whole with water; may be taken with or without food.

Side Effects

Common Side Effects

Generally well tolerated. Uncommon: nausea, vomiting, abdominal discomfort/dyspepsia. Rare: rash/urticaria or other hypersensitivity reactions; transient elevations in liver enzymes.

Side Effect Frequency

Uncommon: gastrointestinal upset (nausea, vomiting, abdominal discomfort/dyspepsia). Rare: hypersensitivity reactions (rash, urticaria, angioedema), transient liver enzyme elevations. Very rare/serious: severe cutaneous adverse reactions (SJS/TEN/AGEP), blood dyscrasias; hepatotoxicity is mainly associated with overdose or chronic supratherapeutic use.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or any excipients; severe hepatic impairment/active severe liver disease.

Warnings & Precautions

Do not exceed recommended dose; do not use with other paracetamol-containing products; increased liver injury risk with overdose, chronic alcohol use, hepatic disease, malnutrition/dehydration-use caution and consider lower max daily dose; seek medical advice if symptoms persist (e.g., >3 days for fever or pain) and stop immediately if rash/skin reaction occurs.

Age Restriction

Children: use only with medical advice; this 500 mg tablet is generally not suitable for children under 6 years (prefer pediatric formulations).

Driving Warning

Safe

Drug Interactions

Interaction Severity

MAJOR: Excess/chronic alcohol use (hepatotoxicity risk). MODERATE: Warfarin (INR increase with regular/repeated paracetamol use), isoniazid, enzyme inducers such as carbamazepine/phenytoin/rifampicin (increased hepatotoxicity risk). MINOR: Metoclopramide/domperidone (faster absorption), cholestyramine (reduced absorption if taken close together).

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Safe

Children

Children 2-5 years: 120-250mg every 4-6 hours (max 4 doses/24h). Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24h). Dose by weight: 10-15mg/kg every 4-6 hours. Not recommended in children under 2 years without medical supervision

Elderly

325-500 mg every 4 hours or 500-1000 mg every 6 hours; maximum 4000 mg per 24 hours; reduce by 50-75% in hepatic impairment or alcohol abuse

Kidney Impairment

If CrCl/eGFR 10-50 mL/min: dose every 6 hours; if <10 mL/min: dose every 8 hours (avoid shortening intervals).

Liver Impairment

Use with caution in hepatic impairment; in chronic liver disease or risk factors (e.g., chronic alcohol use/malnutrition), limit total daily dose to ≤2,000 mg and/or extend dosing interval; avoid in severe hepatic impairment/active severe liver disease unless specifically directed by a clinician.

Storage & Patient Advice

Storage Conditions

Store below 30°C, keep in a dry place away from light, keep out of reach of children

Missed Dose

If needed, take a dose when remembered; if it is near the next dose, skip the missed dose-do not double; keep at least 4 hours between doses.

Stopping the Medicine

May be stopped when no longer needed; no tapering is required. Avoid abrupt discontinuation only if it has been used regularly at high doses for prolonged periods-seek medical advice to ensure ongoing pain/fever is appropriately evaluated and to avoid exceeding the maximum daily dose.

Overdose

Early symptoms may be absent or include nausea/vomiting/abdominal pain/pallor within 24 h; severe hepatotoxicity can be delayed (24-72 h+) and may be fatal; seek emergency care immediately-management includes prompt N-acetylcysteine (antidote) and activated charcoal if presentation is early, plus supportive care.

Patient Counseling

Do not exceed 1000 mg per dose and 4000 mg/day (8 tablets of 500 mg) in adults; keep ≥4 hours between doses; avoid taking any other paracetamol-containing products (e.g., cold/flu remedies); avoid or limit alcohol; seek urgent advice after overdose even if well; if fever persists >3 days or pain >5 days (or symptoms worsen), consult a clinician.

Monitoring Requirements

No routine monitoring required for short-term use; liver function tests recommended with long-term use or in patients with hepatic risk factors

Pharmacology

Mechanism of Action

Inhibits prostaglandin synthesis in the central nervous system and blocks pain impulse generation peripherally; reduces fever by acting on the hypothalamic heat-regulating center to increase heat dissipation

Duration of Effect

4-6 hours.

Metabolism

Primarily hepatic conjugation: glucuronidation ~50-70% and sulfation ~20-40%; minor CYP-mediated oxidation (mainly CYP2E1, also CYP1A2/CYP3A4) to NAPQI, detoxified by glutathione at therapeutic doses

Excretion

Primarily renal excretion as metabolites (glucuronide/sulfate conjugates); about 2-5% is excreted unchanged in urine.

Product Information

Available Dosage Forms

Common paracetamol dosage forms include tablets (immediate/modified release), capsules/caplets, oral solution/syrup/suspension, suppositories, and intravenous infusion/injection (hospital use).

Composition per Dose

Each tablet: 500mg paracetamol

Generic Availability

Yes

OTC Alternatives

Ibuprofen (NSAID) and aspirin (adults only; avoid in children/teens with viral illness) are common OTC alternatives for pain/fever, subject to contraindications.

Pain Type

General

Nsaid

No

Opioid

No

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