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Analgesic / Antipyretic Pregnancy: §4.6, verbatim: 'Pregnancy — A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopmental disorders in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy for the shortest possible time, at the lowest effective dose and at the lowest possible frequency. Breastfeeding — Paracetamol is excreted into breast milk. No undesirable effects on nursing infants have been reported. Paracetamol 500 mg capsules, soft may be used in therapeutic dosages in breast-feeding women.'

Paracetamol

Brand names: Panadol, Calpol, Perfalgan (IV)

Used in: Burns

Paracetamol (acetaminophen) is a widely used analgesic and antipyretic for mild-to-moderate pain and fever, available over the counter and as a prescription medicine.

Adult dose

Dose: 500-1000 mg (one to two 500 mg soft capsules) per dose, by mouth. §4.2 Posology, verbatim: 'For adults and children aged 16 years and older, the usual dosage is 1 to 2 capsules (500-1000 mg) at a time, up to four times daily as required, with a maximum of 8 capsules (4000 mg) every 24 hours.' Strength is pinned by the product itself — 'Panadol 500 mg Soft Capsule' — and restated in milligrams in that sentence. ORAL 500 mg CAPSULES ONLY: no intravenous or rectal paracetamol label is in this bundle, so no dose is published for the page's 'IV, PR' routes.
Route: Oral — Panadol 500 mg soft capsules. §4.2 Method of administration, verbatim: 'Capsule — The capsules should be swallowed with enough water. The intake of paracetamol with food or drink doesn't influence the efficacy of the medicine.' SCOPE: no IV or rectal paracetamol label is in this bundle, so those routes are unsourced and no dose is published for them.
Frequency: Up to four times daily as required. §4.2, verbatim: 'These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.' and 'The administration interval must be at least 4 hours.'
Max: Maximum 8 capsules (4000 mg) every 24 hours — adults and children aged 16 years and older (§4.2, verbatim: 'with a maximum of 8 capsules (4000 mg) every 24 hours').
SCOPE: oral 500 mg capsules only — the page's IV and rectal routes are not covered by this bundle and their regimens are NOT carried. || §4.2 instructions for use, verbatim: 'The treatment should be kept as short as possible. The administration interval must be at least 4 hours. Do not exceed the recommended daily dose on account of the risk of severe hepatic damage (see section 4.4 and 4.9). Do not use in combination with other paracetamol-containing products. Depending on the recurrence of symptoms (fever and pain), repeated administration is allowed. If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse or if other symptoms occur, the treatment must be stopped, and a doctor must be consulted.' || REDUCED CEILING, §4.4 verbatim: 'The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case.' This label states a 2 g/day ceiling ONLY for that group — not for low body weight, and not for hepatic impairment generally. || US cross-check (different product, different market): 'adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last, do not take more than 6 gelcaps in 24 hours' — the gelcap strength is not stated anywhere in the fetched US text, so that count cannot be converted to milligrams and has not been used.

Paediatric dose

Route: Oral — Panadol 500 mg soft capsules, swallowed whole with enough water. §4.2: 'A suitable dosage form should be used.'
Frequency: Up to four times daily as required. §4.2, verbatim: 'These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.'
Max: Maximum 4 whole capsules (2000 mg) per day for ages 10-15 years (§4.2 table row: '10-15 | 1 capsule at a time | up to four times daily as required | 4 whole capsules | 2000'). From 16 years the adult ceiling applies: 'a maximum of 8 capsules (4000 mg) every 24 hours'.
dosePerKg is null deliberately: this label doses children by AGE BAND in whole 500 mg capsules and states no milligram-per-kilogram treatment dose anywhere, so there is no per-kg figure that may drive a weight calculator. concentration is null because the product is a solid capsule, not a liquid with a milligram-per-millilitre strength. AGE BANDS, §4.2 table (columns: age in years | number of capsules at a time | frequency of dosing | maximum number of capsules per day | maximum daily dosage in mg), read row by row: '10-15 | 1 | up to four times daily as required | 4 whole capsules | 2000' and '>=16 | 1-2 | up to four times daily as required | 8 whole capsules | 4000'. LOWER AGE BAR, §4.2 verbatim: 'This medicine is suitable for adults and children aged 10 years and older.' No dose for children under 10 years appears anywhere in this label, so none is published. DURATION, §4.2 verbatim: 'Children should not be given this medicine, for more than 3 days without consulting a doctor.' COMBINATION CAUTION, §4.4 verbatim — a restriction, not a dose: 'For children a treatment of 60 mg/kg/day of paracetamol combined with another antipyretic is not allowed, unless due to a lack of efficacy.' Verify all under-18 dosing, and any oral-suspension, intravenous or rectal formulation, against a current children's formulary — no such label is in this bundle.

Dose adjustments

Renal

Not stated as a dose adjustment — this label gives no renal dosing rule. §4.4 records a caution only, verbatim: 'Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency...' Absence of a stated adjustment is not evidence that none is needed; check the full current SPC.

Hepatic

§4.4, verbatim: 'The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol.' §4.4 also lists as requiring caution 'mild to moderate hepatic insufficiency (incl. Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function... and chronic malnutrition', but states no reduced dose for those groups. The 2 g/day ceiling above is stated ONLY for the chronic-alcoholism / non-cirrhotic alcoholic liver case.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim and complete — the only contraindication in this label: 'Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1'
  • Not a §4.3 contraindication but a §4.4 absolute instruction: 'The recommended dose should not be exceeded.' and 'Patients must be advised not to use any other paracetamol-containing products at the same time.'
  • Not a §4.3 contraindication but a §4.4 bar in chronic alcoholism: 'The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol.'
  • §4.4 cautions (not contraindications): 'moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl. Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition'; also 'asthmatic patients who are sensitive to acetylsalicylic acid as mild bronchospasms have been reported as a cross-reaction'; and patients 'with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis'.
  • Excipients, §4.4 verbatim: 'This medicine contains 20 mg propylene glycol in each soft capsule.' and 'This medicine contains 108 mg sorbitol liquid in each soft capsule. Sorbitol is a source of fructose' — relevant in hereditary fructose intolerance.
  • INCOMPLETE LIST WARNING: §4.4 was truncated at the source-fetch limit mid-sentence, so any further bars stated after the sorbitol paragraph were not retrieved.

Side effects

  • §4.8 summary, verbatim: 'At therapeutic doses few undesirable effects occur.'
  • Very rare (<1/10,000), §4.8: thrombocytopenia; agranulocytosis
  • Very rare (<1/10,000), §4.8: 'Anaphylaxis. Cutaneous hypersensitivity reactions including, among others, skin rashes and angiodema. Very rare cases of serious skin reactions have been reported.'
  • Very rare (<1/10,000), §4.8: bronchospasm — 'There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.'
  • Very rare (<1/10,000), §4.8: hepatic dysfunction
  • Frequency not known, §4.8: 'High anion gap metabolic acidosis — Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.'
  • §4.4, verbatim: 'The taking of several daily doses at once can cause severe damage to the liver. In such cases, a loss of consciousness will not occur. However, immediate medical help must be sought even if the patient feels well because of the risk of irreversible damage to the liver.'

Monitoring

  • Overdose vigilance — §4.4, verbatim: 'The taking of several daily doses at once can cause severe damage to the liver... immediate medical help must be sought even if the patient feels well because of the risk of irreversible damage to the liver (see section 4.9).'
  • Total paracetamol exposure — §4.4, verbatim: 'Patients must be advised not to use any other paracetamol-containing products at the same time.' (§4.2 repeats: 'Do not use in combination with other paracetamol-containing products.')
  • Duration and response — §4.2, verbatim: 'If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse or if other symptoms occur, the treatment must be stopped, and a doctor must be consulted.' and 'The treatment should be kept as short as possible.'
  • Long-term use — §4.4, verbatim: 'Long-term or frequent use is not advised' and 'Long-term use can be harmful except under medical supervision.'
  • Analgesic-overuse headache — §4.4, verbatim: 'After the long-term use (> 3 months) of analgesics with intake every other day or more frequently, headache can occur or become worse. Headache which is caused by the excessive use of analgesics (drug-dependent headache) must not be treated by increasing the dose.'
  • Persisting fever — §4.4, verbatim: 'In the case of a high fever, symptoms of secondary infection or the persistence of symptoms, it will be necessary to reconsider the treatment.'
  • No routine laboratory monitoring is required by this label at therapeutic doses, and none is asserted here.
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

Its precise mechanism is incompletely understood but is thought to involve central inhibition of prostaglandin synthesis, with little peripheral anti-inflammatory effect.

Prescribing in practice

  • Overdose causes potentially fatal hepatotoxicity; counsel patients not to exceed the recommended maximum daily intake and to check that other combination products do not also contain paracetamol.
  • Dose reduction or extended dosing intervals are advised in hepatic impairment, chronic alcohol use, low body weight and other risk factors for liver injury.
  • Acute overdose is managed urgently with acetylcysteine guided by serum paracetamol levels and a treatment nomogram; refer to current poisoning guidance.

Monitoring

Routine monitoring is not required at therapeutic doses, but liver function and paracetamol levels are checked after suspected overdose.

Counselling the patient

  • Do not take more than the stated dose, and do not combine multiple paracetamol-containing products.
  • Seek urgent medical help after any overdose even if you feel well.
  • Tell a clinician if you drink alcohol regularly or have liver problems.

Evidence & guidelines

Paracetamol is a long-established first-line agent for pain and fever recommended across UK and international guidelines.

Reference: MHRA Paracetamol Overdose Guidelines; 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).

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