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Opioid + paracetamol combination Pregnancy: Use should be avoided during the first trimester, as with all medicines. A large amount of data on paracetamol in pregnancy indicate neither malformative nor feto/neonatal toxicity, and if clinically needed paracetamol can be used at the lowest effective dose for the shortest possible time. Regular use of co-dydramol 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. Administration to nursing women is not recommended as dihydrocodeine may be secreted in breast milk and may cause respiratory depression in the infant.

Dihydrocodeine with paracetamol

Brand names: co-dydramol, Galake, Remedeine

Used in: Burns

This is a fixed-dose combination of the weak opioid dihydrocodeine with paracetamol (co-dydramol), used for moderate pain not relieved 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: One to two tablets every four to six hours when necessary (Co-dydramol 10 mg/500 mg Tablets — dihydrocodeine tartrate 10 mg with paracetamol 500 mg per tablet). Adults and children over 16 years.
Route: Oral
Frequency: Every four to six hours when necessary
Max: Eight tablets in 24 hours
SOURCE CAVEAT: the retrieved SPC is for Co-dydramol 10 mg/500 mg Tablets. Higher-strength co-dydramol products (e.g. 20/500 and 30/500) have their own SPCs and may differ — verify the strength being prescribed. Elderly: as for adults, however a reduced dose may be required if renal or hepatic function is impaired. Children aged 12 to 15 years: one tablet every four to six hours when necessary, to a maximum of four tablets in 24 hours; not recommended for children under 12 years of age — verify any paediatric use against a children's formulary. The dosage should be reduced in hypothyroidism and in renal insufficiency; alcohol should be avoided. Patients should be advised not to exceed the recommended dose and not to take other paracetamol-containing products concurrently. When dihydrocodeine is prescribed for chronic use, care should be taken to avoid unnecessary increase in dosage, and the risk-benefit of continued use should be assessed regularly by the prescriber. Prior to starting opioid treatment, discuss and put in place a strategy for ending treatment to minimise the risk of addiction and drug withdrawal syndrome. Taking a painkiller for headaches too often or for too long can make them worse.

Dose adjustments

Renal

The dosage should be reduced in renal insufficiency (and in hypothyroidism). Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment; liver disease is a contraindication. A reduced dose may be required in the elderly if renal or hepatic function is impaired.

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

  • Respiratory depression
  • Chronic obstructive airways disease
  • Liver disease
  • Hypersensitivity to the active substances or to any of the excipients
  • Should not be given during an asthma attack, as dihydrocodeine may bring about histamine release (§4.4)

Side effects

  • Constipation, nausea, vomiting, headache or vertigo — relatively common if the dose is increased above 30 mg of dihydrocodeine; upper abdominal pain (not known)
  • Tolerance and drug dependence, especially with prolonged dosage; drug withdrawal syndrome (uncommon), with restlessness and irritability on stopping
  • Hypersensitivity including skin rash; anaphylactic shock and angioedema (not known)
  • Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis and fixed drug eruption (not known)
  • Agranulocytosis and thrombocytopenia (not known); high anion gap metabolic acidosis (not known); very rare occurrences of pancreatitis

Interactions

  • 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 duration and monitor closely (§4.4)
  • Alcohol — should be avoided; the hazards of paracetamol overdose are greater in those with alcoholic liver disease (§4.4)
  • Other paracetamol-containing products — must not be taken concurrently (§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 §4.4

Clinical monograph

How it works

Dihydrocodeine is a mu-opioid receptor agonist providing central analgesia, while paracetamol contributes analgesic and antipyretic effects through poorly understood central mechanisms; the two act by complementary routes.

Prescribing in practice

  • Because the product contains paracetamol, avoid concomitant paracetamol from other sources to prevent inadvertent overdose and hepatotoxicity.
  • The opioid component carries risks of respiratory depression, constipation, dependence and tolerance, with additive sedation alongside alcohol and other CNS depressants.
  • Use reduced doses and caution in the elderly and in hepatic or renal impairment, and prescribe for the shortest effective period.

Monitoring

Monitor pain control, sedation, bowel function and total daily paracetamol intake from all sources during use.

Counselling the patient

  • Do not take any other paracetamol-containing products alongside this medicine.
  • Avoid alcohol and report excessive drowsiness or slow breathing.
  • Use measures to prevent constipation and do not exceed the stated dose.

Evidence & guidelines

Compound analgesics combining a weak opioid with paracetamol are recognised options for moderate pain when simple analgesia is insufficient.

Reference: NICE NG140; NICE NG193; FPM Opioids Aware; 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.