FEVADOL PLUS TAB 20/TAB

Indications

Approved Uses

Short-term symptomatic relief of acute mild-to-moderate pain (e.g., headache/migraine, dental pain, musculoskeletal pain, dysmenorrhea) when simple analgesics alone are insufficient; may also reduce fever due to the paracetamol component.

Dosage & Administration

Initial Dose

1-2 tablets (Paracetamol 500-1000mg / Codeine 8-16mg / Caffeine Citrate 30-60mg)

Maximum Dose

Adults: maximum 8 tablets in 24 hours (paracetamol 4 g/day; codeine 64 mg/day; caffeine citrate 240 mg/day). Adolescents 12-15 years: generally avoid codeine-containing products; if exceptionally used under specialist direction, do not exceed 4 tablets/24 hours. Not for children <12 years.

How to Take

Swallow tablets whole with a full glass of water. May be taken with or without food. Do not crush or chew.

Side Effects

Common Side Effects

Drowsiness, dizziness, lightheadedness, nausea, vomiting, constipation, headache, dry mouth.

Safety & Warnings

Age Restriction

Not approved under 12 years.

Driving Warning

Avoid Driving

Drug Interactions

Interaction Severity

MAJOR: Alcohol and other CNS depressants (e.g., benzodiazepines) → additive sedation/respiratory depression; MAO inhibitors (avoid/contraindicated) → increased risk of serious CNS/respiratory effects; Opioid antagonists (e.g., naltrexone) → reduced analgesia/possible withdrawal in dependent patients. MODERATE: Warfarin (chronic/high-dose paracetamol may increase INR/bleeding risk); strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, bupropion) → reduced codeine activation and analgesic effect. MINOR/OTHER: Metoclopramide may increase paracetamol absorption rate; cholestyramine may reduce paracetamol absorption.

Special Populations

Breastfeeding

Use with caution; codeine may cause infant sedation/respiratory depression due to variable CYP2D6 metabolism; paracetamol and caffeine generally compatible in low doses. Avoid if breastfeeding infant <2 weeks or with known poor CYP2D6 metabolizer status.

Elderly

Start with 1 tablet per dose, extend dosing interval to every 6-8 hours, monitor for sedation and respiratory depression, reduce maximum daily dose due to increased sensitivity to opioids and risk of paracetamol accumulation.

Kidney Impairment

Renal impairment: extend dosing interval (e.g., every 6-8 hours if CrCl 10-50 mL/min; every 8-12 hours if CrCl <10 mL/min) and use the lowest effective dose; avoid prolonged use in severe renal failure.

Storage & Patient Advice

Storage Conditions

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

Missed Dose

Take as soon as remembered; skip if near next scheduled dose. Do not double the dose.

Stopping the Medicine

If used regularly for more than a few days, do not stop abruptly; taper if prolonged/frequent use to reduce opioid withdrawal risk, and seek medical advice if withdrawal symptoms occur.

Overdose

Overdose can cause delayed but severe paracetamol hepatotoxicity (nausea/vomiting, RUQ pain, rising LFTs, hepatic failure) and opioid toxicity from codeine (CNS depression, miosis, respiratory depression, hypotension), with possible caffeine toxicity (tachycardia, agitation, tremor/seizures). Management: urgent emergency care; activated charcoal if early and appropriate; N‑acetylcysteine for paracetamol toxicity per nomogram; naloxone and ventilatory support for opioid-induced respiratory depression; supportive/ICU care as needed.

Pharmacology

Mechanism of Action

Paracetamol provides analgesic/antipyretic effects primarily via central prostaglandin synthesis inhibition; codeine is a prodrug partially converted by CYP2D6 to morphine that activates μ-opioid receptors to reduce pain perception; caffeine is an adjuvant (adenosine receptor antagonism/CNS stimulation) that can enhance analgesic efficacy in headache-type pain.

Duration of Effect

4-6 hours

Metabolism

Paracetamol: hepatic glucuronidation/sulfation with a minor CYP2E1 pathway producing NAPQI; codeine: hepatic metabolism via CYP2D6 (to morphine) and CYP3A4 (to norcodeine) plus conjugation; caffeine: hepatic metabolism primarily via CYP1A2.

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: Paracetamol 500mg + Caffeine Citrate 30mg + Codeine 8mg

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen (where appropriate) for mild-to-moderate pain/fever.

Pain Type

General, Migraine

Nsaid

No

Opioid

Yes

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