Paracetamol 500mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains: 500mg Paracetamol For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
For oral administration.
Adults, the elderly and children over 12 years:
Single dose 0.5 g - 1 g (1 to 2 tablets) every 4-6 hours.
Maximum daily dose 4 g (8 tablets) in divided doses.
Children:
Age 6 years to under 12 years: half tablet to one tablet every 4-6 hours.
Maximum daily dose 2 g (4 tablets) in divided doses.
Age under 6 years: this formulation is not appropriate except on medical advice.
Dosage instruction
1 - Dose should not be repeated more frequently than 4 hour intervals.
2 - Not more than 4 doses should be administered in any 24 hour period.
3 - Dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol and/or other constituents.
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.
Although the hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease; however, there have been reports of severe hepatotoxicity including fatalities, in chronic alcoholics who have taken Paracetamol in amounts within the
recommended therapeutic range (See section 4.8).
Published reports suggest that Paracetamol toxicity could occur in some individuals whilst taking the recommended daily dose of Paracetamol.
Care should be taken when paracetamol is prescribed to patients with liver diseases, and in those on potentially hepatotoxic effects.
Increase in the level of transaminases has been occasionally, and temporarily observed as a result of taking the recommended daily dose of paracetamol. High anion gap metabolic acidosis has been reported to be associated with therapeutic
ingestion of Paracetamol.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children
Do not take with any other paracetamol-containing products.
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.
Contains Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 the absorption reduced by colestyramine.
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.
Chronic alcohol intake could enhance the hepatotoxicity of paracetamol overdose. Acute alcohol intake may diminish an individual's ability to metabolise large doses of Paracetamol, the plasma half-life of which can be prolonged.
Paracetamol may decrease busulfan clearance when used in combination.
May interact with chloramphenicol causing increased plasma levels.
Patients receiving enzyme inducing drugs such as carbamazepine are considered at high risk of overdose. In cases of overdose an antidote should be administered even if their plasma-paracetamol concentrations are up to 50% below the standard reference line.
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.
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
None.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including, skin rashes, drug fever and mucosal lesions, anaphylactic reactions, angioedema, urticaria, Stevens-Johnson Syndrome and cases of fixed drug eruption have been reported. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily casually related to paracetamol. The development of severe hepatotoxicity, including fatalities, has been reported in chronic alcoholics, who have taken paracetamol in amounts within the daily recommended doses.
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, phenobarbital, 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: Analgesic and Antipyretic ATC code: N02BE01
Analgesic - the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain- impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic- paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat - regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.
The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdose and cause liver damage.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone BP Lactose BP Starch (Maize) BP Magnesium Stearate BP Sodium Starch Glycollate BP Colloidal Anhydrous Silica BP
6.2 Incompatibilities
None known
6.3 Shelf life
3 Years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Child-resistant blister packs of 48, 60, 96 and 100 tablets.
PVC/aluminium IPVC 250/20/15 micron Glassine paper 35g/sqm/Adehesive lacquer 2.5g/sqm/Aluminium foil (9 micron)/ Heat seal coating 7.0g/sqm/PVC 250 micron Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Relonchem Limited Cheshire House
Gorsey Lane, Widnes, Cheshire WA8 0RP, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0078
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/06/2011
10 DATE OF REVISION OF THE TEXT
02/12/2014