PANADOL NIGHT TAB 20/TAB

Indications

Approved Uses

Temporary relief of mild-to-moderate pain associated with difficulty sleeping (e.g., headache, backache, muscular aches, minor arthritis pain, toothache, period pain) and to aid sleep due to the sedating antihistamine component.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years: 2 tablets taken about 20 minutes before bedtime as needed; maximum 2 tablets in 24 hours; do not use for more than 7 consecutive nights without medical advice.

Initial Dose

2 tablets (1000 mg paracetamol + 50 mg diphenhydramine HCl) taken at bedtime. The claim specifies '20 minutes before bedtime' which is not supported; the label states 'at bedtime' or 'taken at bedtime.'

Maintenance Dose

2 tablets once nightly as needed

Maximum Dose

2 tablets (1000mg paracetamol + 50mg diphenhydramine HCl) per 24 hours

Children's Dosage

Not recommended for children under 12 years of age. Some formulations suggest not for use in children under 16 years.

Dose Adjustment Notes

Hepatic impairment/alcohol misuse: avoid or use only with medical advice due to paracetamol hepatotoxicity risk; renal impairment: use with caution; elderly: use with caution/consider avoidance due to increased sensitivity to diphenhydramine (anticholinergic effects, falls, confusion).

Side Effects

Common Side Effects

Drowsiness/sedation (including next-day drowsiness), dizziness, dry mouth, blurred vision, constipation, and urinary retention.

Side Effect Frequency

Very common/common: drowsiness/somnolence (and next-day sedation), dizziness, dry mouth; Common: impaired concentration/psychomotor performance, blurred vision; Less common/rare: constipation, urinary retention/hesitancy, palpitations/tachycardia, confusion (especially elderly), paradoxical excitation, hypersensitivity reactions; Hepatotoxicity is primarily associated with paracetamol overdose rather than therapeutic use.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or diphenhydramine (or excipients); concomitant use with MAO inhibitors or within 14 days of stopping an MAOI; children <12 years; avoid concomitant use with other paracetamol- or diphenhydramine-containing products.

Warnings & Precautions

Do not exceed recommended dose; do not use with other paracetamol-containing products; avoid alcohol and other sedatives/CNS depressants; may cause marked drowsiness/next-day impairment-do not drive/operate machinery; avoid other antihistamine/diphenhydramine products; use caution/seek advice in liver disease, renal impairment, chronic alcohol use, elderly (falls/confusion), glaucoma, urinary retention/BPH, and chronic respiratory disease/asthma; short-term use only (seek medical advice if symptoms persist).

Age Restriction

Not recommended/contraindicated in children under 12 years (adult/≥12 years only).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

MAO inhibitors (current or within 14 days); alcohol and other CNS depressants (additive sedation/respiratory depression risk); other paracetamol-containing products (overdose/hepatotoxicity risk); other antihistamines/diphenhydramine products and anticholinergics (additive anticholinergic toxicity); warfarin (INR may increase with regular/prolonged paracetamol use).

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Children

Not recommended for children under 12 years of age. Some formulations suggest not for use in children under 16 years.

Liver Impairment

Use with caution in hepatic impairment; avoid in severe hepatic impairment/active liver disease and in chronic heavy alcohol use unless medically supervised.

Storage & Patient Advice

Missed Dose

Taken as needed at bedtime; if you miss the bedtime dose, skip it and do not take an extra dose or a second dose the same night/next morning.

Stopping the Medicine

Can be stopped at any time; intended for short-term use only (generally not more than 7-10 consecutive nights without medical advice).

Patient Counseling

Take 2 tablets about 20 minutes before bedtime only; max 2 tablets in 24 hours; do not use >7 nights without medical advice; avoid alcohol and other sedatives; do not take with any other paracetamol/acetaminophen-containing products; may cause next-day drowsiness-do not drive/operate machinery if affected; seek advice before use if liver disease, significant renal impairment, glaucoma, urinary retention/prostate enlargement, chronic lung disease/OSA, or in older adults.

Monitoring Requirements

No routine monitoring for short-term OTC use. Monitor liver function with prolonged use or in patients with hepatic risk factors.

Pharmacology

Half-Life

Paracetamol (acetaminophen): ~2-3 hours (range ~1-4 hours) in healthy adults; Diphenhydramine: ~4-9 hours (range ~2-9 hours), may be longer in older adults/hepatic impairment.

Bioavailability

Paracetamol: ~88%. Diphenhydramine: ~40-60%

Excretion

Paracetamol: primarily hepatic metabolism (glucuronidation/sulfation) with renal excretion of metabolites; diphenhydramine: hepatic metabolism with renal excretion mainly as metabolites.

Product Information

Available Dosage Forms

Tablet (caplet)

Composition per Dose

Each tablet: Paracetamol 500mg + Diphenhydramine Hydrochloride 25mg

Generic Availability

Yes

Pain Type

General

Nsaid

No

Opioid

No

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