Paracetamol Tablets Bp 500mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets B.P. 500mg Paracetamol 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg
3 PHARMACEUTICAL FORM
Tablet
White capsule shaped tablet debossed “PARA 500” with a break line
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Analgesic and antipyretic, mild to moderate pain including headache, tooth-ache, rheumatic pains, period pains, colds and influenza symptoms
4.2 Posology and method of administration
Adults and children over 12 years:
1-2 tablets to be swallowed every 4-6 hours. Do not exceed 4 doses (8 tablets) in 24 hours.
Children 6 to 12 years:
Half to one tablet every 4-6 hours. Do not exceed 4 doses (4 tablets) in 24 hours.
The tablets should be given to children below the age of 6 only as directed by a doctor.
Under no circumstances must the daily dose of paracetamol exceed four grams in 24 hours.
4.3 Contraindications
Use with care in patients with liver damage or suffering from alcoholism or known hypersensitivity to Paracetamol and/ or other constituents which is rare.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Paracetamol should be used with caution where there are indications of impaired liver or kidney functions. Longer intervals between doses are advisable if kidneys are impaired.
The hazards of overdose are greater in those with non-cirrhotic alcoholic disease.
Do not exceed the stated dose.
Do not take with any other paracetamol-containing products concurrently.
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.
Keep out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
If being taken regularly or in high doses may potentiate action of some anticoagulants. May also potentiate metoclopramide and reduce effect of cholestyramine.
The anti-coagulant 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 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 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 rash may occur. There have been reports of blood dyscrasia including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.
4.9 Overdose
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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
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 and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the GI tract.
Peak plasma concentrations are usually seen in 1-2 hours.
It is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates.
Less than 5% is excreted unchanged.
Plasma protein binding occurs only slightly in normal therapeutic use.
5.3 Preclinical safety data
N/A. Paracetamol has been used in general medicines over a prolonged period
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch Sodium Metabisulphate Magnesium Stearate Colloidal Anhydrous Silica
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years.
Special precautions for storage
6.4
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Opaque blister packs comprised of 250 micron rigid opaque PVC and 20 micron hard tempered aluminium foil
Pack sizes: 16, 24, 25, 32
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Medley Pharma Limited Unit 2A,
Olympic Way Sefton Business Park Liverpool L30 1RD UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 43870/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/03/2009 11/12/2014