Paracetamol 500mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol
3 PHARMACEUTICAL FORM
Tablet
Almost white, circular flat bevelled-edge tablets with a score line on one side.
For a full list of excipients, see section 6.1.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of headache, rheumatic pains, neuralgia and relief of symptoms of colds and influenza.
4.2 Posology and method of administration
For oral use.
Adults and children over 12 years of age
One to two tablets to be taken three to four times daily at intervals of not less than four hours, up to a maximum of eight tablets in 24 hours.
Children 6 to 12 years of age
Half to one tablet to be taken three or four times daily at intervals of not less than four hours, up to a maximum of four tablets in 24 hours.
Elderly
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to paracetamol and/or any of the other ingredients. Severe liver disease.
4.4 Special warnings and precautions for use
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 non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Not to be given to children under 6 years, without medical advice.
Dosage should not be continued for more than three days without consulting your doctor.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Keep all medicines out of the reach and sight of children.
Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Leaflet or combined label/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 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.
4.6 Pregnancy and lactation
Pregnancy
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Lactation
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
Paracetamol 500mg Tablets has no known influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.
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/vellowcard.
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
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 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 24 h from ingestion should be discussed with the NPIS or a liver unit.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Analgesics and Antipyretics - Anilides ATC Code - N02BE01
Paracetamol is a peripherally acting analgesic with antipyretic activity.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucoronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose-dependent.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch Starch, pregelatinised Stearic acid
Incompatibilities
6.2
Not applicable.
6.3 Shelf life
PV C/PV dC blister 36 months
PVC blister 24 months
HDPE bottle 36 months
6.4 Special precautions for storage
None - This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Child-resistant blisters of 250pm PVC/ 40gsm PVdC/ 35gsm Glassine Paper/ 9pm Soft Temper Aluminium foil. Pack sizes of 6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32 tablets (not all pack sizes will be marketed).
Child-resistant blisters of 250pm PVC/ 35gsm Glassine Paper/ 9pm Soft Temper Aluminium foil. Pack sizes of 6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32 tablets (not all pack sizes will be marketed).
White High Density Polyethyelene bottle fitted with a Polypropylene Child Resistant Cap with a cap liner of Aluminium/Surlyn or Aluminium/Polyethylene. Pack sizes of 30, 32 tablets (not all pack sizes will be marketed).
6.6
Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Max Remedies Ltd William Nadin Way Swadlincote Derbyshire DE11 0BB
8 MARKETING AUTHORISATION NUMBER(S)
PL 31308/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/12/2009
10 DATE OF REVISION OF THE TEXT
10/11/2015