Compound Analgesic (Paracetamol + Codeine) Pregnancy: 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 itself, if clinically needed, can be used at the lowest effective dose for the shortest time. Breast-feeding: contraindicated — codeine may be secreted in breast milk and cause infant respiratory depression; in CYP2D6 ultra-rapid metabolisers higher morphine levels may very rarely cause fatal infant opioid toxicity.

Co-codamol 30/500

Brand names: Kapake, Solpadol, Tylex

Co-codamol 30/500 is a fixed-dose combination of codeine phosphate and paracetamol used for moderate musculoskeletal and post-operative orthopaedic pain not relieved by paracetamol alone. The 30/500 strength delivers the higher codeine content within the combination tablet.

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 (Co-codamol 30/500 — 30 mg codeine phosphate and 500 mg paracetamol per capsule)

Route: Oral

Frequency: Not more frequently than every 4 to 6 hours

Max: 8 capsules in any 24 hour period

Elderly: as for adults, however a reduced dose may be required. Duration of treatment should be limited to 3 days; if no effective pain relief is achieved the patient/carer should be advised to seek the views of a physician, and the duration of treatment should be as short as possible. Before initiating, agree a treatment strategy including treatment duration, treatment goals and a plan for ending treatment, in line with pain management guidelines; maintain frequent physician–patient contact to review the need for continued 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 the underlying disease. Repeated use can lead to opioid use disorder even at therapeutic doses. PAEDIATRIC: the SPC gives separate regimens for 16–18 years and for 12–15 years, and states co-codamol is NOT recommended in children under 12 years because of the risk of opioid toxicity from variable and unpredictable CYP2D6 metabolism of codeine to morphine; it is contraindicated in all patients aged 0–18 years undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Verify any paediatric dose against a children's formulary. Source quote (§4.2): 'Adults: Two capsules not more frequently than every 4 to 6 hours, up to a maximum of 8 capsules in any 24 hour period.'

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, 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) undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome
Patients known to be CYP2D6 ultra-rapid metabolisers

Side effects

Constipation, nausea, vomiting, dry mouth (typical opioid effects; frequency not known)
Dizziness, light-headedness, confusion, drowsiness (frequency not known)
Respiratory depression and bronchospasm (frequency not known)
Drug dependence, tolerance and drug withdrawal syndrome (withdrawal syndrome uncommon)
Urinary retention (frequency not known) and miosis
Hypersensitivity including skin rash; very rare serious skin reactions; anaphylactic shock and angioedema (frequency not known)
Very rare: thrombocytopenia, neutropenia, leucopenia; not known: agranulocytosis; high anion gap metabolic acidosis (pyroglutamic acidosis) with paracetamol in at-risk patients

Clinical monograph

How it works

Codeine is a weak opioid that is metabolised to morphine to act on mu-opioid receptors, while paracetamol provides central analgesic and antipyretic action through poorly understood central mechanisms; together they give additive analgesia.

Prescribing in practice

Because the tablet contains paracetamol, warn against taking any additional paracetamol-containing products to avoid inadvertent overdose and hepatotoxicity, and never exceed the stated maximum tablets in 24 hours.
Codeine is converted to morphine by CYP2D6 and effect varies with metaboliser status — ultra-rapid metabolisers risk opioid toxicity, so it is contraindicated in breastfeeding and avoided in children, while interacting CYP2D6 inhibitors and other CNS depressants increase risk.
Use for the shortest effective period, anticipate constipation and the potential for dependence, and reduce dose or avoid in significant renal or hepatic impairment per the SPC.

Monitoring

Monitor pain control, bowel function, and signs of opioid sedation or excessive use, and reassess the need to continue at each review.

Counselling the patient

Do not take any other medicine containing paracetamol at the same time.
Expect possible constipation and drowsiness; do not drive if affected, and do not drink alcohol.
Take it only as needed for short-term pain and seek advice before stopping a regular course to avoid withdrawal.

Evidence & guidelines

NICE guidance supports short-term, lowest-effective-dose opioid-containing analgesia for acute pain and cautions against routine long-term use.

Reference: NICE NG59; WHO Analgesic Ladder; MHRA Drug Safety Update (codeine in children, 2013); 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways