PANADOL ACTIFAST TAB 20/TAB

Indications

Approved Uses

Short-term relief of mild to moderate pain (e.g., headache, toothache, musculoskeletal/backache, dysmenorrhea, sore throat) and reduction of fever, including aches and pains associated with colds/flu.

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 (4 g paracetamol).

Initial Dose

Adults (16+ years): 1-2 tablets (500-1000mg). Children (12-15 years): 1 tablet (500mg).

Maintenance Dose

Adults (16+ years): 1-2 tablets every 4-6 hours as needed. Children (12-15 years): 1 tablet every 4-6 hours as needed.

Maximum Dose

Adults (16+ years): 8 tablets (4000mg) in 24 hours. Children (12-15 years): 4 tablets (2000mg) in 24 hours.

Children's Dosage

Not recommended for children under 12 years in this formulation. For children 6-12 years: paracetamol 250-500mg per dose (use age-appropriate formulations). Dose by weight: 10-15mg/kg every 4-6 hours, max 4 doses/24 hours.

Dose Adjustment Notes

Hepatic impairment/chronic alcohol use/malnutrition: use the lowest effective dose, avoid prolonged high-dose use, and consider a lower maximum daily dose (often ≤3 g/day) or avoidance in severe hepatic disease; Renal impairment (CrCl <30 mL/min): extend dosing interval (e.g., every 6-8 hours).

How to Take

Swallow tablets with water (a full glass is reasonable); do not crush or chew; may be taken with or without food.

Side Effects

Common Side Effects

At recommended doses, adverse effects are uncommon; may include nausea and other mild GI upset; serious reactions are rare (e.g., hypersensitivity/skin reactions).

Side Effect Frequency

At recommended doses, adverse effects are uncommon/rare; possible rare hypersensitivity reactions (rash, urticaria, angioedema, anaphylaxis) and very rare serious skin reactions (SJS/TEN/AGEP) and blood dyscrasias (e.g., thrombocytopenia). Hepatotoxicity is primarily associated with overdose or high-risk situations (e.g., chronic alcohol use, malnutrition, liver disease).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or to any excipients.

Warnings & Precautions

Do not exceed the recommended dose; do not use with other paracetamol/acetaminophen-containing products; seek urgent help after overdose even if asymptomatic; use caution/seek advice in liver disease, chronic alcohol use, malnutrition/dehydration, and renal impairment; stop and seek care if rash or hypersensitivity occurs (risk of severe skin reactions); contains sodium bicarbonate-consider sodium load in patients on sodium-restricted diets/heart failure/renal disease; seek medical advice if symptoms persist (e.g., pain >5 days or fever >3 days).

Age Restriction

Not recommended for children under 12 years (unless specifically directed by a clinician).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (regular/prolonged paracetamol may increase INR/bleeding risk); alcohol and other hepatotoxic drugs (additive liver injury risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (may increase hepatotoxicity risk); cholestyramine (reduces absorption if given close in time); metoclopramide/domperidone (increase absorption rate); probenecid (reduces clearance/increases exposure); flucloxacillin (rare risk of high anion gap metabolic acidosis, especially with risk factors).

Interaction Severity

MAJOR: Chronic heavy alcohol use or active liver disease (increased hepatotoxicity risk). MODERATE: Warfarin with regular/prolonged paracetamol use (may increase INR), enzyme inducers (carbamazepine, phenytoin, rifampicin) and isoniazid (increased hepatotoxicity risk). MINOR/PK: Metoclopramide/domperidone (faster absorption), cholestyramine (reduced absorption if close together), probenecid (increased paracetamol exposure).

Food Interaction

No clinically significant food restriction; may be taken with or without food (onset may be faster when taken on an empty stomach).

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Category B; considered safe but use lowest effective dose and duration.

Breastfeeding

Safe

Children

Not recommended for children under 12 years in this formulation. For children 6-12 years: paracetamol 250-500mg per dose (use age-appropriate formulations). Dose by weight: 10-15mg/kg every 4-6 hours, max 4 doses/24 hours.

Elderly

Standard adult dosing generally applicable. Use minimum effective dose. Caution with prolonged use due to increased risk of renal and hepatic impairment. Maximum 3g/day recommended in frail elderly.

Liver Impairment

Use with caution in hepatic impairment; avoid in severe hepatic impairment/active liver disease; if used in chronic liver disease, use the lowest effective dose and limit total daily dose to 2-3 g/day (with longer dosing intervals as needed).

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original packaging. Keep out of reach of children.

Missed Dose

If needed, take a dose when remembered unless it is close to the next dose; do not double doses; keep at least 4 hours between doses and do not exceed the daily maximum.

Stopping the Medicine

No tapering is required. May be stopped when symptoms resolve. If used regularly for more than a few days or for chronic pain/fever, consult a healthcare professional before stopping and reassess the underlying condition. Do not exceed the recommended dose or duration; seek medical advice if frequent or long-term use is needed.

Overdose

Overdose may be initially asymptomatic or cause nausea/vomiting/abdominal pain, progressing to hepatotoxicity and possible liver failure (typically 24-72 hours); seek emergency care immediately even if well; management includes activated charcoal if early and prompt N-acetylcysteine (most effective when started within 8-10 hours) with monitoring of LFTs/INR/renal function.

Patient Counseling

Adults and adolescents ≥12 years: Take 1-2 tablets (500 mg each) every 4-6 hours as needed; do not exceed 8 tablets (4 g paracetamol) in 24 hours. Do not use with any other paracetamol/acetaminophen-containing products. Seek urgent medical help immediately in case of overdose, even if you feel well. Use with caution/seek advice before use if you have liver disease, chronic alcohol use, severe renal impairment, or are on a low-sodium diet/need sodium restriction (this product contains sodium bicarbonate). Avoid excessive alcohol. Stop and seek medical advice if pain persists >5 days or fever >3 days, symptoms worsen, or if rash/possible allergy occurs.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider liver function monitoring if prolonged/frequent use or in higher-risk patients (e.g., liver disease, chronic alcohol use, malnutrition) and INR monitoring if used regularly with warfarin.

Pharmacology

Mechanism of Action

Paracetamol provides analgesic/antipyretic effects primarily via central inhibition of prostaglandin synthesis; sodium bicarbonate buffers gastric contents, improving tablet dissolution and speeding absorption (faster onset).

Onset of Action

Onset typically ~15-30 minutes; peak concentrations may occur around ~30 minutes in fasted subjects, and this formulation is faster than standard paracetamol tablets.

Duration of Effect

4-6 hours

Half-Life

About 2 hours in healthy adults (typical range ~1-3 hours).

Bioavailability

Approximately 60-90% (commonly cited ~63-89%); sodium bicarbonate may speed absorption/onset but does not meaningfully change overall extent of bioavailability.

Metabolism

Hepatic metabolism predominantly via glucuronidation (~50-60%) and sulfation (~25-35%); a minor CYP-mediated pathway (mainly CYP2E1, also CYP1A2/CYP3A4) forms NAPQI, which is detoxified by glutathione at therapeutic doses.

Excretion

Primarily renal as metabolites: >90% excreted in urine mainly as glucuronide and sulfate conjugates; about 2-5% excreted unchanged.

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%, often cited <20%); binding may increase at high/overdose concentrations.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Paracetamol 500mg + Sodium Bicarbonate 173mg

Generic Availability

Yes

OTC Alternatives

Paracetamol standard immediate-release 500 mg products; ibuprofen 200-400 mg; aspirin 300-500 mg (adults only; avoid in children/teens with viral illness).

Pain Type

General

Nsaid

No

Opioid

No

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