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Opioid + paracetamol combination Pregnancy: Should not be used during pregnancy, since this medicine is a fixed combination of active ingredients including tramadol. Paracetamol: animal studies are insufficient to conclude on reproductive toxicity; a large amount of data on pregnant women indicate neither malformative nor feto/neonatal toxicity; epidemiological studies on neurodevelopment after in utero exposure show inconclusive results. Tramadol: inadequate evidence available to assess safety in pregnant women; does not affect uterine contractility when given before or during birth, may induce usually non-clinically-relevant changes in neonatal respiratory rate, and long-term treatment during pregnancy may lead to withdrawal symptoms in the newborn. Breast-feeding: should not be used during lactation, or breast-feeding should be discontinued during treatment; discontinuation of breast-feeding is generally not necessary following a single dose.

Tramadol with paracetamol

Brand names: Tramacet, Maxitram

Used in: Burns

A fixed-dose oral combination of the opioid tramadol with paracetamol, used for moderate pain where a single analgesic is insufficient. This page covers the combination tablet and its opioid-related cautions.

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: An initial dose of two tablets is recommended (product strength: 37.5 mg tramadol hydrochloride / 325 mg paracetamol per tablet); additional doses can be taken as needed
Route: Oral — tablets must be swallowed whole with a sufficient quantity of liquid; they must not be broken or chewed
Frequency: As needed; the dosing interval should not be less than six hours
Max: 8 tablets per day (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol)
Source is the Tramacet 37.5 mg/325 mg film-coated tablet SPC (https://www.medicines.org.uk/emc/product/6630/smpc) — both components of the fixed combination are covered. Use should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol; the dose should be adjusted to the intensity of pain and the sensitivity of the individual patient, selecting the lowest effective dose for analgesia. The stated adult regimen applies to 'Adults and adolescents (12 years and older)'. Should under no circumstances be administered for longer than is strictly necessary; if repeated or long-term treatment is required, undertake careful regular monitoring with breaks in treatment where possible. To avoid inadvertent overdose, advise patients not to exceed the recommended dose and not to use any other paracetamol-containing (including over the counter) or tramadol-containing products concurrently without medical advice. Not recommended in severe respiratory insufficiency. Tramadol is not suitable as a substitute in opioid-dependent patients. Before initiating treatment, agree a treatment strategy including duration, goals and an end-of-treatment plan with the patient; taper gradually on stopping to prevent withdrawal. OLDER PATIENTS: dose adjustment not usually necessary up to 75 years without clinically manifest hepatic or renal insufficiency; over 75 years elimination may be prolonged, so extend the dosage interval as required. PAEDIATRIC (non-numeric, per §4.2): 'The effective and safe use of Tramadol hydrochloride/Paracetamol has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population.' NOTE ON SOURCES: eMC §4.5 was not captured in the fetched bundle — the interactions listed are drawn from §4.3/§4.4/§4.8; clinician to check the full §4.5.

Dose adjustments

Renal

In patients with renal insufficiency the elimination of tramadol is delayed; prolongation of the dosage intervals should be carefully considered according to the patient's requirements. In severe renal insufficiency (creatinine clearance <10 ml/min — printed as '<10 ml/mm' in §4.4) the combination is not recommended.

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
  • Acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs
  • Patients receiving monoamine oxidase inhibitors, or within two weeks of their withdrawal
  • Severe hepatic impairment
  • Epilepsy not controlled by treatment

Side effects

  • Very common: nausea; dizziness; somnolence
  • Common: vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence; headache, trembling; confusional state, mood altered, anxiety, nervousness, euphoric mood, sleep disorders; hyperhidrosis, pruritus
  • Uncommon: palpitations, tachycardia, arrhythmia; hypertension, hot flush; dyspnoea; involuntary muscular contractions, paraesthesia, amnesia; depression, hallucinations, nightmares; albuminuria, micturition disorders (dysuria and urinary retention); transaminases increased; tinnitus; chills, chest pain; dysphagia, melaena; dermal reactions (rash, urticaria)
  • Rare: ataxia, convulsions, syncope, speech disorders; vision blurred, miosis, mydriasis; delirium, drug dependence
  • Also possible from the individual components (not observed in the combination trials): postural hypotension, bradycardia, collapse; allergic reactions with respiratory symptoms (dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis; changes in appetite, motor weakness and respiratory depression. Unknown frequency: hypoglycaemia. Repeated use can lead to drug dependence, even at therapeutic doses

Interactions

  • Monoamine oxidase inhibitors — contraindicated concurrently or within two weeks of their withdrawal (§4.3)
  • Opioid agonist-antagonists (nalbuphine, buprenorphine, pentazocine) — concomitant use is not recommended (§4.4)
  • Medicines that lower the seizure threshold — selective serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics, local anaesthesia; convulsions have been reported in tramadol-treated patients taking these (§4.4)
  • Other serotonergic agents — serotonin syndrome, a potentially life-threatening condition, has been reported with tramadol in combination with other serotonergic agents or with tramadol alone (§4.4)
  • Other paracetamol-containing (including over the counter) or tramadol-containing products — must not be used concurrently without medical advice, to avoid inadvertent overdose (§4.4)
  • Warfarin — post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times (§4.8)

Clinical monograph

How it works

Tramadol is a weak mu-opioid agonist that also inhibits serotonin and noradrenaline reuptake, while paracetamol provides centrally mediated analgesia; the pairing combines a faster-acting and a longer-acting component.

Prescribing in practice

  • Watch the total paracetamol load — account for paracetamol from all sources to avoid inadvertent overdose and hepatotoxicity, and be aware of tramadol's dependence and respiratory depression risk.
  • Tramadol lowers the seizure threshold and can precipitate serotonin syndrome, so avoid co-prescribing with other serotonergic agents and in epilepsy.
  • Reduce dose or extend the dosing interval in renal or hepatic impairment and in the elderly.

Monitoring

Monitor analgesic response, sedation, respiratory status and cumulative paracetamol intake from all preparations.

Counselling the patient

  • Do not take any other paracetamol-containing product alongside this medicine.
  • Avoid alcohol and report excessive drowsiness or difficulty breathing.
  • Use only as directed and tell your prescriber if pain is not controlled.

Evidence & guidelines

The combination is supported by acute-pain randomised trials showing additive analgesia, with safety based on established paracetamol and opioid data.

Reference: NICE; FPM; 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.

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