SOLPADEINE CAP 20/CAP

Indications

Approved Uses

Short-term treatment of acute, moderate pain when other analgesics (e.g., paracetamol or ibuprofen alone) are not sufficient, such as headache/migraine, dental pain, backache, musculoskeletal pain, and dysmenorrhea.

Dosage & Administration

Initial Dose

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

Maximum Dose

Adults and adolescents ≥12 years: maximum 8 capsules in 24 hours (paracetamol 4 g/day; codeine 64 mg/day; caffeine citrate 240 mg/day); not indicated/contraindicated in children <12 years.

How to Take

Swallow capsules whole with water; may be taken with or without food. Do not exceed the prescribed dose and leave at least 4-6 hours between doses.

Side Effects

Common Side Effects

Nausea, vomiting, constipation, dizziness, drowsiness, headache, dry mouth, sweating

Safety & Warnings

Age Restriction

Not approved under 12 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/clinically important: alcohol, benzodiazepines and other CNS depressants (additive sedation/respiratory depression); MAOIs within 14 days (serious CNS/respiratory effects); other opioids. Important: warfarin/other coumarins with repeated paracetamol use (↑INR/bleeding risk); CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) reduce codeine activation/analgesia; enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin) increase hepatotoxicity risk with paracetamol and may reduce analgesic effect; metoclopramide/domperidone (↑paracetamol absorption), colestyramine (↓absorption); flucloxacillin with paracetamol (risk of high anion gap metabolic acidosis, especially with risk factors).

Interaction Severity

MAJOR: other CNS depressants (alcohol, benzodiazepines, sedative-hypnotics, other opioids) → additive sedation/respiratory depression. CONTRAINDICATED/AVOID: concomitant MAOIs or within 14 days (opioid toxicity/CNS effects). MODERATE: warfarin with repeated/prolonged paracetamol use (↑INR/bleeding); strong CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) may reduce codeine analgesia; enzyme inducers (e.g., rifampicin/carbamazepine/phenytoin) may increase paracetamol hepatotoxicity risk. MODERATE (safety signal): flucloxacillin with paracetamol may increase risk of high anion gap metabolic acidosis in predisposed patients.

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Contraindicated

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

For intended short-term use, it can generally be stopped when pain resolves; if used regularly for more than a few days or at high doses, stopping may cause withdrawal symptoms-seek medical advice and taper if dependence is suspected.

Overdose

Overdose may cause early nausea/vomiting/abdominal pain with delayed severe hepatotoxicity (paracetamol), CNS depression/miosis/respiratory depression/coma (codeine), and agitation/tremor/tachycardia (caffeine); management is urgent medical assessment, consider activated charcoal if early, give N-acetylcysteine for paracetamol toxicity per nomogram/timing, and naloxone plus airway/ventilatory support for opioid toxicity, with monitoring of LFTs/INR and clinical status.

Pharmacology

Mechanism of Action

Paracetamol provides central analgesic and antipyretic effects (largely via central prostaglandin pathway modulation); codeine is a prodrug partially converted by CYP2D6 to morphine that activates μ-opioid receptors; caffeine acts as an analgesic adjuvant (adenosine receptor antagonism) that can enhance analgesic response.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Bioavailability

Paracetamol: ~70-90% oral bioavailability (often cited ~80-90%); caffeine: near-complete absorption (~100%); codeine: well absorbed orally with moderate bioavailability (commonly ~50-60%) due to first-pass metabolism.

Metabolism

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

Excretion

Primarily renal excretion as metabolites: paracetamol mostly as glucuronide/sulfate conjugates; codeine and metabolites (including morphine conjugates) in urine; caffeine metabolites in urine.

Product Information

Available Dosage Forms

Capsule (this SFDA-registered product). Other Solpadeine brand presentations may exist in some markets (e.g., tablets/soluble/effervescent), but they are not interchangeable and are not part of this specific SFDA product record.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

Paracetamol alone or ibuprofen (if no contraindications) for mild to moderate pain; consider topical NSAIDs for localized musculoskeletal pain where appropriate.

Pain Type

General, Migraine

Nsaid

No

Opioid

Yes

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