Paracetamol/Codeína Kern Pharma (Paracetamol, Codeine Phosphate Hemihydrate)

Paracetamol/Codeine is used in the management of pain and fever through its action on the central nervous system and peripheral pain pathways.

• Mild to moderate acute pain: provides relief when non‑opioid analgesics are insufficient.
• Post‑operative pain: helps control discomfort after surgical procedures.
• Dental pain: reduces pain associated with dental extractions or procedures.
• Fever: lowers elevated body temperature in adults.
• Musculoskeletal pain: eases discomfort from strains, sprains and back pain.

• Paracetamol works primarily by inhibiting central cyclooxygenase enzymes, reducing prostaglandin synthesis in the brain, which lowers the pain threshold and antipyretic set‑point. Codeine phosphate hemihydrate is a pro‑drug that is metabolised to morphine, binding to µ‑opioid receptors in the central nervous system to produce analgesia and modest cough suppression. The combination provides additive pain relief through distinct mechanisms.

Paracetamol/Codeine may cause a range of adverse reactions, most of which are dose‑dependent and reversible.

Common Side Effects

• Nausea: mild to moderate stomach upset.
• Constipation: reduced bowel movements.
• Drowsiness: feeling of sleepiness or reduced alertness.
• Dizziness: light‑headed sensation.
• Dry mouth: reduced salivation.
• Sweating: increased perspiration.

Serious or Rare Side Effects

• Respiratory depression: slowed breathing, especially at higher doses.
• Hepatotoxicity: liver injury from excessive paracetamol exposure.
• Allergic reactions: rash, itching, swelling or anaphylaxis.
• Seizures: rare occurrence, often linked to overdose.
• Dependence or abuse potential: risk of opioid‑related misuse.
• Low blood pressure: hypotension in susceptible individuals.

Paracetamol/Codeine should be used with caution in specific clinical situations and according to professional guidance.

• Liver disease: avoid or limit use due to risk of hepatotoxicity.
• Renal impairment: adjust use as kidney function may affect drug clearance.
• Respiratory conditions: monitor for respiratory depression in asthma or COPD.
• Concomitant CNS depressants: increased sedation when combined with alcohol or benzodiazepines.
• Pregnancy and lactation: use only if clearly needed and prescribed.
• Children and adolescents: not recommended for routine use in patients under 18 years.
• Store at ambient temperature: keep in original packaging, protect from moisture and heat.

Paracetamol/Codeine can interact with several medicines, altering efficacy or safety.

Major Interactions (Avoid)

• MAO inhibitors: risk of severe serotonin syndrome.
• Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): reduce conversion of codeine to morphine, decreasing analgesia.
• CNS depressants: additive sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

• Warfarin: may increase bleeding risk through hepatic enzyme modulation.
• Antihistamines: can enhance drowsiness.
• Diuretics: may affect renal clearance of paracetamol.
• Anticonvulsants: may alter hepatic metabolism of both components.