PANADOL EXTEND 665/MG TAB 24/TAB

Indications

Off-Label Uses

No specific off‑label use is necessary to state; osteoarthritis pain is an on‑label/common use for analgesic paracetamol products, while other off‑label uses are not routinely recommended for this OTC product.

Dosage & Administration

Dosing by Condition

Adults (typically ≥12 years per many MR paracetamol labels; follow local label): 2 tablets (1330 mg) every 6-8 hours as needed; maximum 6 tablets (3990 mg) in 24 hours; do not take more than 3 doses (of 2 tablets) in 24 hours.

Maintenance Dose

2 tablets (1330mg) every 6-8 hours as needed

Children's Dosage

Not recommended for children under 12 years. Adolescents 12-18 years: use standard immediate-release paracetamol formulations; the 665mg extended-release tablet is intended for adults.

Dose Adjustment Notes

Renal impairment: extend dosing interval in severe impairment (e.g., CrCl <30 mL/min) and avoid excessive total daily dose; hepatic impairment/chronic alcohol use/malnutrition or low body weight: use the lowest effective dose and consider a reduced maximum daily dose; avoid overdose in all patients.

Side Effects

Side Effect Frequency

Usually none at recommended doses; uncommon/rare: nausea or abdominal discomfort; hypersensitivity reactions such as rash/urticaria/angioedema/anaphylaxis; rare blood disorders (e.g., thrombocytopenia); very rare serious skin reactions (SJS/TEN/AGEP).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Do not exceed the recommended dose; do not use with other paracetamol/acetaminophen-containing products; seek urgent help after overdose even if well; use caution/seek medical advice before use in liver disease, chronic alcohol use, malnutrition/dehydration, or renal impairment; stop and seek care if rash or hypersensitivity occurs (rare severe skin reactions); extended-release tablet-swallow whole (do not crush/chew/split); seek medical advice if symptoms persist (e.g., pain/fever for several days)

Drug Interactions

Drug Interactions

Warfarin/other coumarins (enhanced anticoagulant effect with regular/prolonged use); cholestyramine (reduced absorption if given close in time); metoclopramide or domperidone (increased absorption rate); alcohol and hepatic enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s wort) and isoniazid (increased hepatotoxicity risk); probenecid (reduced clearance/increased exposure)

Food Interaction

No restriction.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Australian Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus.

Children

Not recommended for children under 12 years. Adolescents 12-18 years: use standard immediate-release paracetamol formulations; the 665mg extended-release tablet is intended for adults.

Liver Impairment

Use with caution in hepatic impairment; reduce total daily dose and/or extend dosing interval; avoid/contraindicated in severe hepatic impairment or active liver disease

Storage & Patient Advice

Patient Counseling

Do not exceed the recommended dose; for Panadol Extend 665 mg (modified/extended-release paracetamol), adults and ≥12 years: 2 tablets every 6-8 hours as needed; maximum 6 tablets (3,990 mg) in 24 hours. Do not take with any other medicines containing paracetamol/acetaminophen (including cold/flu products). Swallow tablets whole with water-do not crush, chew, or split. Avoid alcohol and use caution in liver disease, chronic alcohol use, or malnutrition. Seek medical advice if symptoms persist/worsen (e.g., pain >3 days or fever >3 days) or if you are taking warfarin long-term. In overdose, get urgent medical help immediately even if you feel well (risk of delayed severe liver injury). Keep out of reach of children.

Monitoring Requirements

No routine monitoring required at therapeutic doses. Monitor liver function tests in patients with pre-existing hepatic disease or prolonged use.

Pharmacology

Onset of Action

Onset typically within ~30-60 minutes; the modified‑release formulation provides an initial release for earlier effect with sustained release maintaining levels for several hours.

Half-Life

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

Bioavailability

70-90%.

Excretion

Renal excretion predominantly as glucuronide and sulfate conjugates (>90%); <5% excreted unchanged.

Protein Binding

Low protein binding, approximately 10-25% at therapeutic concentrations (may increase in overdose).

Product Information

Available Dosage Forms

For paracetamol/acetaminophen generally: tablets (including film‑coated and modified/extended‑release), capsules/caplets, oral liquid (solution/suspension), suppositories, and IV infusion/injection (hospital use).

Generic Availability

Yes

Pain Type

Joint, Muscular

Nsaid

No

Opioid

No

 

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