1. Name Of The Medicinal Product
Paracetamol Tablets 500mg.
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of headache, rheumatic pains, neuralgia and relief of symptoms of colds and influenza.
For oral administration.
4.2 Posology And Method Of Administration
Adults and children over 12 years
One to two tablets to be taken three or 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
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 any of the ingredients. Severe liver disease.
4.4 Special Warnings And Precautions For Use
Should be taken with caution in patients with impaired liver and kidney function.
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 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
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol when 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
No adverse effects known.
4.8 Undesirable Effects
Side-effects are usually mild and may include skin rashes and other allergic reactions occasionally. Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytoosis, but these were not necessarily causally related to paracetamol.
4.9 Overdose
Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe cases liver failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop with or without severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Liver damage is likely 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 overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has 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 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 glucuronide 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
Pregelatinised maize starch
Stearic acid
Purified water (not detectable in the final formulation)
6.2 Incompatibilities
None known
6.3 Shelf Life
PVC/PVdC blister 36 months
PVC blister 24 months
Glass bottle 36 months
HDPE bottle 36months
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
1. A child-resistant push through pack of opaque 250 micron PVC/40 gsm PVdC blisters, heat sealed to 35 gsm Glassine paper/9 micron soft temper aluminium foil.
Pack sizes: 6/8/10/12/16/18/20/24/25/30/32/36/48/96
2. A child-resistant push through pack of opaque 250 micron PVC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.
Pack sizes: 6/8/10/12/16/18/20/24/25/30/32/36/48/96
3. Amber glass bottle with a child-resistant polyethylene/polypropylene cap fitted with a tamper evident heat sealed liner of surlyn/aluminium or aluminium/polyethylene or a child resistant polyethylene/polypropylene cap fitted with a waxed aluminium faced liner.
Pack sizes: 30, 32, 36, 50, 100.
4. Amber glass bottle with a tinplate cap, fitted with a waxed aluminium faced pulpboard liner.
Pack sizes: 1000.
5. White pigmented high density polyethylene bottle fitted with a polypropylene child resistant cap with an induction heat sealable liner including aluminium and surlyn or aluminium/polyethylene.
Pack size: 30, 32, 36, 50, 100.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 0014/0578
9. Date Of First Authorisation/Renewal Of The Authorisation
First Authorisation: 8 May 1997
10. Date Of Revision Of The Text
October 2004
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