Summary of Product Characteristics (SmPC) - Paracetamol 1000 mg tablets
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 1000 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to off white, caplet shaped tablets, plain on both sides.
4.1 Therapeutic indications
Paracetamol 1000 mg Tablets 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, the elderly and children 16 years and over:
Take one tablet every 4-6 hours as required.
Not recommended for children under 16 years if age.
The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hours.
Renal impairment:
It is recommended when giving paracetamol to patients with renal impairment, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours unless directed otherwise by a physician. See table:
| Glomerular filtration rate | Dose |
| 10-50 ml/min | 500 mg every 6 hours |
| <10 ml/min | 500 mg every 8 hours |
This product is not suitable for patients with renal insufficiency when a reduced dose is required. More appropriate forms are available for that circumstance.
Hepatic impairment:
In patients with hepatic impairment or Gilbert’s Syndrome, the dose should be reduced or the dosing interval prolonged. The daily dose should not exceed 2 g/day unless directed by a physician.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Patients should be advised not to take other Paracetamol containing products concurrently.
Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. Underlying liver disease increases the risk or paracetamol related liver damage.
Do not exceed the stated dose.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (refer also to section 4.9).
Use with caution in patients with glutathione depletion due to metabolic deficiencies.
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.
If symptoms persist, medical advice must be sought. Keep out of the sight and reach of children.
Patients should be advised to consult their doctor if headaches become persistent.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
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 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.
The speed of absorption of paracetamol tablets may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 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.
Lactation:
After oral administration, paracetamol is excreted into breast milk in small quantities in recommended dosages. No undesirable effects on nursing infants have been reported. Consequently, paracetamol tablets may be used in breast-feeding. Available published data do not contraindicate breastfeeding.
Fertility:
There are no available data on the effect of paracetamol on fertility.
4.7 Effects on ability to drive and use machines
None.
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 and frequency.
The frequency using the following convention: 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 available data), including isolated reports.
Adverse event frequencies have been estimated from spontaneous reports received
through post-marketing data.
Post Marketing Data
| Body System | Undesirable effect | Frequency |
| Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis | Very Rare |
| Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including, among others, Skin rashes and angioedema. Very rare cases of serious skin reactions have been reported. | Very Rare |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm* | Very Rare |
| Hepatobiliary disorders | Hepatic dysfunction | Very Rare |
| Metabolism and nutrition disorders | High anion gap metabolic acidosis | 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 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 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:
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, 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.
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 Nacetylcysteine 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics and antipyretics, anilides; ATC-code:N02B E01
Paracetamol is an antipyretic analgesic. The mechanism of action 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
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. 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. 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
Pregelatinised starch
Povidone
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in the original package in order to protect from light.
6.5 Nature and contents of container
PVC/PVdC/aluminium blisters: 20, 30, 40, 50 & 100 tablets Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Special Concept Development (UK) Limited T/A RxFarma, Colonial Way, Watford,
Hertfordshire,
WD24 4YR, United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 36722/0113
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/04/2025
10 DATE OF REVISION OF THE TEXT
27/08/2026