Paracetamol Caplets 500 Mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets BP 500 mg Paracetamol Caplets 500 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg
Excipients of known effect: sodium metabisulphite (E223)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Analgesic and antipyretic, mild to moderate pain such as headache, toothache, rheumatic pains, period pains and the symptoms of colds and influenza.
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 not 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
Hypersensitivity to paracetamol and/or other constituents.
Contains sodium metabisulphite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
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. Longer intervals between doses are advisable if kidneys impaired.
Do not exceed the recommended 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 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.
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 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.
4.6 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 dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally 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 induce liver enzymes.
or
b, Regularly consumes ethanol in excess of recommended amounts. or
c, Is likely to be glutathione depleted 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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analides, ATC Code: N02BE01
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 metabisulphite (E223) Magnesium stearate Colloidal anhydrous silica
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 Years
6.4 Special precautions for storage
Store below 25°C 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, 48, 50, 84, 96, 100
Polypropylene Containers with HDPE lids (Tablet Containers) or HDPE containers with HDPE lids
Pack sizes: 25, 50, 100, 500, 1000, 5000
6.6 Special precautions for disposal
Not applicable
MARKETING AUTHORISATION HOLDER
7
Athlone Pharmaceuticals Ltd Ballymurray Co. Roscommon Republic of Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL30464/0065
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01 September 2009
10 DATE OF REVISION OF THE TEXT
12/12/2011