ADOL EXTRA 24/CAPLETS

Indications

Approved Uses

Symptomatic relief of mild to moderate pain (e.g., headache, migraine, backache, toothache/dental pain, sore throat, rheumatic/muscular aches, dysmenorrhea/period pain) and reduction of fever, including fever/pain associated with colds and influenza.

Off-Label Uses

None routinely recommended; not used for prophylaxis of headache disorders.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥16 years: 2 tablets per dose every 4-6 hours as needed for pain or fever; maximum 8 tablets in 24 hours; do not take more frequently than every 4 hours.

Initial Dose

2 tablets (Paracetamol 1000mg + Caffeine 130mg)

Maintenance Dose

Two tablets every 4-6 hours as needed.

Maximum Dose

8 tablets per 24 hours (Paracetamol 4000mg / Caffeine 520mg per day); do not exceed 4g paracetamol daily

Children's Dosage

Not recommended for children under 12 years of age. For ages 12-15, consult a doctor or pharmacist. For ages 16 and over, standard adult dosing applies.

Dose Adjustment Notes

Use the lowest effective dose with at least 4-hour intervals; avoid exceeding 4 g/day paracetamol (8 tablets/day). Reduce maximum daily dose/seek medical advice in hepatic impairment, chronic alcohol use, malnutrition/low body weight, dehydration, or severe renal impairment; avoid prolonged continuous use without medical advice.

How to Take

Swallow whole with a full glass of water; can be taken with or without food

Side Effects

Common Side Effects

Usually none when used as directed; possible nausea/GI upset and caffeine-related effects such as nervousness/restlessness, insomnia, palpitations/tachycardia, and dizziness.

Side Effect Frequency

Common: nausea and nervousness/restlessness/insomnia (caffeine-related) may occur; Uncommon/Rare: hypersensitivity reactions including rash/urticaria/bronchospasm and blood dyscrasias (e.g., thrombocytopenia) are rare; Very rare: severe cutaneous adverse reactions (e.g., SJS/TEN/AGEP).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol, caffeine (caffeine citrate), or any excipients; severe hepatic impairment/active liver disease

Warnings & Precautions

Do not exceed recommended dose; do not use with other paracetamol-containing products; seek urgent help after overdose even if well; caution in liver disease, chronic alcohol use, malnutrition, and with other hepatotoxic drugs; caution in renal impairment (extend interval if severe); limit other caffeine sources and avoid late-day dosing if insomnia/anxiety; consider G6PD deficiency caution; avoid prolonged/frequent use to reduce medication-overuse headache risk

Age Restriction

Not recommended for children under 12 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (enhanced anticoagulant effect with regular/prolonged paracetamol use); alcohol and other hepatotoxic drugs (increased hepatotoxicity risk); enzyme inducers (e.g., carbamazepine, phenytoin, rifampicin) and isoniazid (increased hepatotoxicity risk); flucloxacillin (rare risk of high INR)

Interaction Severity

MAJOR: Other paracetamol-containing products (overdose/hepatotoxicity risk). MODERATE: Warfarin/coumarins with regular prolonged paracetamol use (↑INR/bleeding risk); alcohol/chronic heavy alcohol use (↑hepatotoxicity risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑hepatotoxicity risk); flucloxacillin (rare but serious high anion gap metabolic acidosis risk, especially with risk factors); other caffeine sources (additive stimulant effects). MINOR: Cholestyramine (↓absorption if close timing); metoclopramide/domperidone (↑absorption rate).

Food Interaction

No clinically significant food interaction; may be taken with or without food (food can delay onset slightly).

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Not recommended for children under 12 years of age. For ages 12-15, consult a doctor or pharmacist. For ages 16 and over, standard adult dosing applies.

Elderly

Standard adult dosing; use with caution due to increased risk of hepatotoxicity and caffeine sensitivity; ensure adequate hydration

Liver Impairment

Caution; avoid in severe hepatic impairment/active liver disease; in patients with risk factors for hepatotoxicity (e.g., chronic alcohol use, malnutrition), use the lowest effective dose and consider a reduced maximum daily dose (e.g., ≤3 g/day of paracetamol) and/or longer intervals

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

If used for a single dose or short-term (≤2-3 days), it may be stopped without tapering. If taken regularly (daily) for several days or longer, taper by reducing dose/frequency over 2-4 days to minimize caffeine-withdrawal symptoms (e.g., headache, fatigue, irritability). Avoid abrupt discontinuation after prolonged regular use.

Overdose

Medical emergency: early symptoms may be absent or include nausea/vomiting/abdominal pain; serious liver injury can occur 24-72 hours after overdose; management includes urgent assessment, activated charcoal if within ~1 hour, and prompt N-acetylcysteine (NAC) per treatment nomograms; caffeine overdose may cause agitation, tremor, tachycardia/arrhythmias

Patient Counseling

Take 2 tablets every 4-6 hours as needed (≥16 years), max 8 tablets/24 hours; do not take with any other paracetamol-containing products; avoid or limit alcohol; contains caffeine-limit other caffeine sources to reduce insomnia/palpitations; seek medical advice if symptoms persist or if you have liver disease, heavy alcohol use, malnutrition/low body weight, or kidney disease; in overdose, seek urgent medical care immediately even if you feel well.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider liver function/INR monitoring if prolonged or high-frequency use, in hepatic risk factors, or if used regularly with warfarin.

Pharmacology

Mechanism of Action

Paracetamol provides analgesic and antipyretic effects primarily via central inhibition of prostaglandin synthesis and modulation of central pain pathways; caffeine (adenosine receptor antagonist) acts as an analgesic adjuvant that can enhance analgesia and may speed/augment absorption and central pain modulation.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours

Half-Life

Paracetamol: 2-3 hours; Caffeine: 3-5 hours.

Bioavailability

Paracetamol: ~60-88%; Caffeine: ~99%

Metabolism

Hepatic metabolism: Paracetamol undergoes mainly glucuronidation and sulfation, with a minor CYP-mediated pathway (primarily CYP2E1, also CYP1A2/3A4) forming NAPQI; caffeine is metabolized in the liver mainly by CYP1A2 to paraxanthine (major), theobromine and theophylline.

Excretion

Renal excretion: Paracetamol is eliminated mainly in urine (>90%) as glucuronide/sulfate conjugates (small fraction as cysteine/mercapturate); caffeine is eliminated mainly in urine as metabolites with ~1-2% excreted unchanged.

Protein Binding

Paracetamol: 10-25%; Caffeine: 25-36%

Product Information

Available Dosage Forms

Oral tablet (caplet-style tablet).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

Paracetamol alone; ibuprofen; naproxen (where OTC); aspirin (adults only, if appropriate).

Pain Type

General, Migraine

Nsaid

No

Opioid

No

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