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Compound analgesic (weak opioid + paracetamol) Pregnancy: As a precautionary measure, it is preferable to avoid use of co-codamol during pregnancy. Regular use during pregnancy may cause drug dependence in the foetus leading to neonatal withdrawal symptoms; administration during labour may depress respiration in the neonate and an antidote for the child should be readily available. Paracetamol alone can be used if clinically needed at the lowest effective dose for the shortest possible time. Contraindicated during breast-feeding, as codeine may be secreted in breast milk and cause respiratory depression in the infant.

Co-codamol (codeine + paracetamol)

Brand names: Solpadol (30/500), Tylex (30/500), Kapake (30/500), Codipar, Solpadeine Max

Used in: Burns

Co-codamol is a compound analgesic combining codeine with paracetamol, used for mild-to-moderate pain not adequately controlled by paracetamol alone.

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 tablets every four to six hours when necessary (Co-Codamol 15/500 Tablets — codeine phosphate 15 mg with paracetamol 500 mg per tablet)
Route: Oral — tablets are to be taken whole
Frequency: Every four to six hours when necessary
Max: Eight tablets in 24 hours
SOURCE CAVEAT: the retrieved SPC is for Co-Codamol 15/500 Tablets. Other co-codamol strengths (e.g. 8/500 and 30/500) have their own SPCs and may differ — verify the strength being prescribed. Elderly: the adult dose is appropriate (see §4.4 for additional information on elderly patients). Duration: do not take for more than 3 days without consulting a doctor; treatment duration should be as short as possible, and if no effective pain relief is achieved the patient/carer should seek the views of a physician. Adolescents (from SPC paediatric section): 16 to 18 years — one to two tablets every 6 hours when necessary, up to a maximum of eight tablets in 24 hours; 12 to 15 years — one tablet every six hours when necessary, up to a maximum of four tablets in 24 hours. Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to variable and unpredictable metabolism of codeine to morphine. Before initiating treatment, agree a treatment strategy including duration, goals and a plan for ending treatment; when therapy is no longer required it may be advisable to taper the dose gradually to prevent withdrawal symptoms. In the absence of adequate pain control, consider hyperalgesia, tolerance and progression of underlying disease. Verify paediatric use against a children's formulary.

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

Side effects

  • Constipation, nausea, vomiting, dry mouth (not known); pancreatitis (not known)
  • Dizziness, light-headedness, somnolence, headache, seizure (not known)
  • Respiratory depression (not known)
  • Drug dependence, confusional state, dysphoria, euphoria (not known); drug withdrawal syndrome (uncommon) — regular prolonged use of codeine leads to addiction and tolerance
  • Anaphylactic shock, angioedema and allergic reactions including skin rash (not known); very rare cases of serious skin reactions
  • Blood dyscrasias including thrombocytopenia and agranulocytosis (not known); high anion gap metabolic acidosis (not known); ototoxicity leading to sensorineural hearing loss (not known)

Interactions

  • Monoamine oxidase inhibitors — contraindicated concurrently or within 14 days (§4.3)
  • Sedative medicines such as benzodiazepines or related drugs — concomitant use may result in sedation, respiratory depression, coma and death; reserve for patients with no alternative options, use the lowest effective dose for the shortest time and monitor closely (§4.4)
  • Other CNS depressant drugs — care should be observed in any patient whose condition may be exacerbated by opioids, including those on concurrent CNS depressants (§4.4)
  • Flucloxacillin with paracetamol — high anion gap metabolic acidosis due to pyroglutamic acidosis has been reported with the combination, and with prolonged therapeutic-dose paracetamol in severe illness, malnutrition or glutathione deficiency (§4.4)
  • NOTE: eMC §4.5 was not captured in this bundle; the items above are taken from §4.3 and §4.4

Clinical monograph

How it works

Paracetamol provides analgesic and antipyretic effects through central mechanisms, while codeine is an opioid that is metabolised to morphine and acts at opioid receptors to relieve pain.

Prescribing in practice

  • Codeine is metabolised to morphine by CYP2D6 and is contraindicated in known ultra-rapid metabolisers, in children under twelve years, and in breastfeeding, because of the risk of life-threatening opioid toxicity; it is also not recommended after tonsillectomy or adenoidectomy in children.
  • As it contains paracetamol, beware additive overdose from other paracetamol-containing products, and as it contains an opioid it carries risks of dependence, constipation and respiratory depression.
  • Doses are expressed by the strengths of the two components, so prescribe and dispense the specific strength clearly to avoid confusion.

Monitoring

Monitor for adequacy of analgesia, opioid adverse effects such as sedation, constipation and respiratory depression, and ensure total paracetamol intake from all sources is not exceeded.

Counselling the patient

  • Do not take other paracetamol-containing medicines at the same time.
  • It may cause drowsiness and constipation; do not drive if affected.
  • Seek urgent advice if too much is taken, even if you feel well, because of the risk of paracetamol toxicity.

Evidence & guidelines

The combination is supported by long-standing analgesic use and by established safety guidance on codeine metabolism from the MHRA.

Reference: MHRA Drug Safety Update Apr 2013 (codeine in children); NICE NG193 (chronic primary pain 2021); FDA Codeine Black Box Warning; 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.