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Compound Analgesic (Codeine + Paracetamol — Weak Opioid Step-Down) Pregnancy: SPC §4.6: careful consideration should be given before prescribing in pregnancy. Regular use during pregnancy may cause dependence in the foetus, leading to neonatal withdrawal symptoms; administration during labour may depress neonatal respiration and an antidote for the child should be readily available. As a precautionary measure, use should be avoided during the third trimester and during labour. Paracetamol may be used if clinically needed at the lowest effective dose, for the shortest time, at the lowest possible frequency. Breast-feeding: administration to nursing women is not recommended (codeine may be secreted in breast milk and cause respiratory depression in the infant; in CYP2D6 ultra-rapid metabolisers this may be fatal) — breast-feeding is also listed as a contraindication in §4.3.

Co-codamol 30/500 (Post-Operative Step-Down Analgesia)

Brand names: Tylex, Kapake, Solpadol

Co-codamol 30/500 is a fixed combination of codeine and paracetamol used here as oral step-down analgesia after surgery once parenteral opioids are no longer needed.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Two capsules
Route: Oral
Frequency: Not more frequently than every 4 to 6 hours
Max: 8 capsules in any 24 hour period
Source = UK SPC for Co-codamol 30/500 Capsules. NOTE ON UNITS: §4.2 expresses the dose in CAPSULES and does not restate the milligram content of codeine phosphate or paracetamol — confirm the strength of the product actually being prescribed before converting to mg. DURATION: 'The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.' The duration of treatment should be as short as possible. ELDERLY: as for adults, however a reduced dose may be required (see §4.4 warnings). TREATMENT GOALS AND DISCONTINUATION: before initiating treatment, agree a treatment strategy including treatment duration, treatment goals and a plan for ending treatment; maintain frequent physician-patient contact to evaluate the need for continued treatment; when a patient no longer requires therapy it may be advisable to taper the dose gradually to prevent withdrawal symptoms. In the absence of adequate pain control, consider the possibility of hyperalgesia, tolerance and progression of underlying disease. PAEDIATRIC (no per-kg dose is stated in this SPC, so paedDose is null): children aged 16 to 18 years — one to two capsules every 6 hours when necessary, up to a maximum of 8 capsules in 24 hours; children aged 12 to 15 years — one capsule every 6 hours when necessary, to a maximum of 4 capsules in 24 hours; children under 12 years — not recommended, because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine. Codeine-containing products are contraindicated in ALL paediatric patients (0-18 years) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome. Verify all under-18 use against a children's formulary. No §4.5 interactions section was present in the fetched bundle, so no interactions list is given — re-source §4.5 before relying on this draft for interaction checking. The §4.4 warnings text was truncated at the source-fetch limit.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to paracetamol or codeine (rare), or to any of the other excipients
  • Conditions where morphine and opioids are contraindicated, e.g. acute asthma, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, following biliary tract surgery
  • Breast-feeding
  • Monoamine oxidase inhibitor therapy, concurrent or within 14 days
  • All paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome, due to an increased risk of serious and life-threatening adverse reactions
  • Patients known to be CYP2D6 ultra-rapid metabolisers

Side effects

  • Constipation, nausea, vomiting, dry mouth
  • Dizziness, light-headedness, somnolence, confusional state, headache
  • Respiratory depression and bronchospasm
  • Drug dependence and drug withdrawal syndrome (uncommon); tolerance with prolonged high dosage of codeine
  • Hypotension (with high doses); miosis
  • High anion gap metabolic acidosis due to pyroglutamic acidosis (paracetamol-related, in patients with risk factors); very rare thrombocytopenia, neutropenia, leucopenia and serious skin reactions

Clinical monograph

How it works

Paracetamol produces central analgesia and antipyresis through poorly understood central mechanisms, while codeine is a prodrug metabolised to morphine that acts on mu-opioid receptors.

Prescribing in practice

  • Codeine metabolism via CYP2D6 is highly variable, so ultra-rapid metabolisers risk morphine toxicity and poor metabolisers gain little analgesia; it is contraindicated in breastfeeding mothers and in children after tonsillectomy or adenoidectomy for obstructive sleep apnoea.
  • Account for all paracetamol-containing products to avoid exceeding the maximum daily paracetamol intake and causing hepatotoxicity.
  • As an opioid it can cause constipation, sedation and respiratory depression, so co-prescribe a laxative and review duration to limit dependence.

Monitoring

Monitor pain scores, sedation, bowel function and respiratory rate, and review the ongoing need for opioid analgesia regularly.

Counselling the patient

  • Do not take other paracetamol-containing medicines at the same time.
  • It may cause drowsiness and constipation; avoid alcohol and seek advice if breathing feels affected.

Evidence & guidelines

Combination paracetamol-opioid analgesia is supported by NICE postoperative pain guidance and systematic reviews of acute pain management.

Reference: MHRA Drug Safety Update 2013 (codeine children); RCoA Acute Pain Handbook; WHO Analgesic Ladder; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.