Summary of Product Characteristics (SmPC) - Paracetamol 500 mg capsules soft
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 500 mg paracetamol.
Excipients with known effect
Every capsule contains 58.2 mg of sorbitol, 6.0 mg of propylene glycol and 66.4 mg of glycerol.
The capsules may contain trace amounts of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, soft.
White, oblong soft gelatin capsule with a logo printed in black ink.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol 500 mg capsules, soft is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non-serious arthritis.
4.2 Posology and method of administration
Posology
Adults, elderly, and children aged 16 years and over:
One to two capsules every four hours as required, up to a maximum of 8 capsules in any 24-hour period.
Paediatric population
Children
Aged 10 to 15 years:
Give one capsule every four to six hours as required, up to a maximum of four capsules in any 24-hour period.
Not suitable for children under ten years of age.
Children should not be given Paracetamol 500 mg capsules, soft for more than 3 days without consulting a doctor.
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.
Method of administration
Paracetamol 500 mg capsules, soft is administered orally.
4.3 Contraindications
Hypersensitivity to paracetamol, to peanut or soya, or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcohol liver disease.
- Do not exceed the stated dose.
- Patients should be advised to consult their doctor if their headaches become persistent.
- Patients should be advised not to take other paracetamol-containing products concurrently.
- Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
- The capsules contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
- If symptoms persist consult your doctor.
- Keep out of reach and sight of children.
- 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 and 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.
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 colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily 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
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 however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Breastfeeding
After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol may be used in breast-feeding women.
Fertility
There are insufficient fertility data available to indicate paracetamol has any effect on fertility.
4.7 Effects on ability to drive and use machines
Paracetamol 500 mg capsules, soft has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
| Body system | Undesirable effect |
| Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis |
| Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm* |
| Hepatobiliary disorders | Hepatic dysfunction |
| Skin and subcutaneous tissue disorders | Very rare cases of serious skin reactions have been reported |
| Metabolism and nutrition disorders | High anion gap metabolic acidosis (frequency not known) |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs
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 the 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, phenobarbital, 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, haemorrhage, hypoglycaemia, cerebral oedema, 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.
Treatment
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.
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics and antipyretics. Anilides, ATC code: N02BE01.
The mechanism of action
Paracetamol 500 mg capsules, soft is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a selective basis.
5.2 Pharmacokinetic properties
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract.
Distribution
The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 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 30 % may be bound at the concentrations encountered during acute intoxication.
Elimination
Following therapeutic doses 90 - 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
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
Capsule fill
Macrogol
Purified water
Propylene glycol
Povidone
Silica, colloidal anhydrous
Capsule shell
Gelatin
Sorbitol, liquid, partially dehydrated (E420) Purified water
Glycerol
Titanium dioxide (E171)
Capsule printing
Black iron oxide (E172)
Propylene glycol
Hypromellose
Processing Aids
Medium chain triglycerides
Lecithin
Isopropyl alcohol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
Blister formed of PVDC/PVC//Alu/PET, packed into carton.
Pack sizes of 2, 4, 6, 8, 10, 12, 14 or 16capsules in blister. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Patheon Softgels B.V.
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
PL 14338/0011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/02/2025
10 DATE OF REVISION OF THE TEXT
06/02/2025