SOLPADEINE EFF TAB 20/EFF TAB

Indications

Approved Uses

Short-term treatment of acute moderate pain when other analgesics (e.g., paracetamol or ibuprofen alone) are not sufficient.

Dosage & Administration

How to Take

Dissolve the prescribed number of tablets completely in a full glass of water and drink immediately once dissolved.

How to Prepare

Place the tablet(s) in a glass of water, allow to dissolve completely, then drink the solution immediately.

Side Effects

Common Side Effects

Nausea, vomiting, constipation, dizziness, drowsiness, headache, abdominal discomfort

Safety & Warnings

Age Restriction

Contraindicated in children <12 years; in adolescents 12-18 years use only if necessary and avoid/contraindicated after tonsillectomy/adenoidectomy (and generally avoid in those with compromised respiratory function).

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: Alcohol and other CNS depressants (e.g., benzodiazepines, sedating antihistamines, other opioids) due to additive sedation/respiratory depression. MODERATE: Warfarin/coumarins with regular high-dose or prolonged paracetamol use (may increase INR). MODERATE: Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may reduce codeine activation and analgesic effect.

Storage & Patient Advice

Preparation Instructions

Place the tablet(s) in a glass of water, allow to dissolve completely, then drink the solution immediately.

Missed Dose

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

Stopping the Medicine

Because this product contains codeine (an opioid), avoid abrupt discontinuation after regular or prolonged use. If taken for more than a few days or on a scheduled basis, taper gradually under medical advice to reduce withdrawal symptoms. If used only occasionally/short-term at recommended doses, stopping is usually tolerated, but seek medical advice if ongoing use is needed.

Overdose

Overdose requires urgent medical attention: paracetamol toxicity may be initially mild but can cause delayed severe hepatic failure (treat with N-acetylcysteine as indicated); codeine causes CNS/respiratory depression and miosis (treat with airway support and naloxone if needed); caffeine may cause agitation, tachycardia, tremor/seizures-supportive care.

Pharmacology

Mechanism of Action

Paracetamol provides analgesia/antipyresis via central prostaglandin synthesis inhibition; codeine is a prodrug opioid providing analgesia primarily after CYP2D6 conversion to morphine acting at μ-opioid receptors; caffeine (adenosine receptor antagonist) acts as an analgesic adjuvant that can enhance analgesic response.

Duration of Effect

4-6 hours.

Metabolism

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

Product Information

Available Dosage Forms

Soluble tablet (effervescent/soluble).

Composition per Dose

Each effervescent tablet: Paracetamol 500mg + Codeine phosphate equivalent to Codeine 8mg + Caffeine citrate 30mg

OTC Alternatives

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

Pain Type

General

Nsaid

No

Opioid

Yes

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