Paracetamol 500mg Tablets Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Tablets BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Paracetamol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, capsule shaped tablet with a break-line on one face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness, feverish colds.
4.2 Posology and method of administration
For oral administration.
Adults, the elderly and young persons over 12 years:
1 to 2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children 6-12 years:
/ to 1 tablet every 4 hours to a maximum of 4 tablets in 24 hours.
Do not give to children under 6 years of age except on the advice of a doctor.
The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period.
Dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other ingredients.
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. Contains Paracetamol. 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.
If symptoms persist for more than 3 days or get worse consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Cholestyramine: The speed of absorption of paracetamol is reduced by Cholestyramine. Therefore, the Cholestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Warfarin: 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.
Chloramphenicol: Increased plasma concentration of chloramphenicol.
4.6 Fertility, Pregnancy and lactation
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 the 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 known.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to paracetamol.
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 include 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 hrs are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hrs 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 hr. 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 upto 8 hrs post ingestion.
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 hrs from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: N02B E01
Mechanism of Action/ Effect:
Analgesic - the mechanism of analgesic action has 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 thorough the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
5.2 Pharmacokinetic properties Absorption and Fate:
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 overdosage and cause liver damage.
5.3 Preclinical safety data
No data of relevance which is additional to that included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised Maize Starch Sodium Metabisulphite Magnesium Stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 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
Al/PVC child resistant blisters comprised of 20pm hard aluminium foil laminated to 15 pm rigid PVC, and 250pm PVC enclosed in an outer carton. Pack sizes: 8, 12, 16 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Brill Pharma Limited Unit 3, Canalside Northbridge Road Berkhamsted
Hertfordshire, HP4 lEG, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40496/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/03/2011
10 DATE OF REVISION OF THE TEXT
22/05/2014