Summary of Product Characteristics (SmPC) - Paracetamol 500 mg capsules
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient : Paracetamol 500mg.
3 PHARMACEUTICAL FORM
Capsule
For oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol capsules are recommended for the treatment of mild to moderate pain, including rheumatic and muscular pains, backache, nerve pains, headaches including migraine and tension, headache, toothache, and period pains, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu. and for the symptomatic relief of feverishness, cold and flu.
4.2 Posology and method of administration
Method of administration
For oral administration
Posology
Adults, the elderly and children over 16 years:
Two capsules up to 4 times a day. Do not take for more than 3 days without consulting your doctor.
These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.
Paediatric population
Not recommended for children under 10 years of age.
Children 10-15 years of age:
One capsule every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.
The dose should not be repeated more than four times in 24 hours. The dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Paediatric population
Not recommended for children under the age of 10 years.
The patient would be informed of:
- Do not exceed the recommended dose.
- Do not take with any other paracetamol-containing products.
- Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
- Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of' overdose are greater in those with alcoholic liver disease.
- If symptoms persist, consult your doctor.
- Keep out of the reach of children.
- Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
4.5 Interaction with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
4.6 Fertility, Pregnancy and lactation
Pregnancy
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol being used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Breastfeeding
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
4.7 Effects on ability to drive and use machines
This medicine has no influence on the ability to drive and use machines.
4.8 Undesirable effects
The information below lists reported adverse reactions, ranked using the following frequency classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Hypersensitivity including skin rash may occur.
Not known: anaphylactic shock; angioedema
Blood and lymphatic system disorders
Not known: blood dyscrasias including thrombocytopenia and agranulocytosis
Skin and subcutaneous disorders
Very rare cases of serious skin reactions have been reported.
Metabolism and nutrition disorders
High anion gap metabolic acidosis with frequency “Not known” (cannot be estimated from the available data)
Description of selected adverse reactions
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient:
- is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes, or
- regularly consumes ethanol in excess of recommended amounts, or is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, disseminated intravascular coagulation, haemorrhage, hypoglycaemia, cerebral oedema, gastrointestinal bleeding and death. Acute renal failure with acute tubular necrosis strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines (see BNF overdose section).
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Further measures will depend on the severity, nature and course of clinical symptoms of paracetamol intoxication and should follow standard intensive care protocols.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: N02B E01, Other analgesics and antipyretics.
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. The inhibition appears, however, to be on a selective basis. Paracetamol has analgesic and antipyretic actions but has no anti-inflammatory properties.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 to 60 minutes and the half life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch 1500 , Magnesium Stearate , Sodium Lauryl Sulphate . The capsule shell is opaque red/white gelatin 100 mg, containing as colours Erythrosine (E127), Patent Blue V (E131), Titanium Dioxide (E171), and Quinoline Yellow (E104).
6.2 Incompatibilities
None known
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a dry place.
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Blisters pack of 8 or 16 capsules in a carton.
Not all pack sizes may be marketed
Paracetamol 500 mg Capsules are packed in blisters of child resistant foil and white opaque PVC film.
6.6 Special precautions for disposal
No special precautions required.
7 MARKETING AUTHORISATION HOLDER
Fourrts (UK) Pharmacare Limited 5 Braemore Court, Cockfosters Road, Barnet, Hertfordshire EN4 0AE, United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 39484/0057
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28th January 2005
10 DATE OF REVISION OF THE TEXT
07/08/2026