1. Name Of The Medicinal Product
Boots Paracetamol Capsules 500 mg
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsules, hard.
4. Clinical Particulars
4.1 Therapeutic Indications
For relief of headaches, migraine, rheumatic, muscular and back pain, neuralgia, toothache and period pain and to relieve the symptoms of colds and flu.
For oral administration.
4.2 Posology And Method Of Administration
Unless otherwise directed by the doctor:
Adults and children over 12
One to two capsules. The dose can be taken three or four times in any 24 hour period, at least four hours apart. Do not take more than eight capsules in 24 hours.
Do not take these capsules for more than three days without consulting your doctor.
Children under 12
Not recommended.
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 by patients with impaired liver or kidney function.
The hazards of overdose are greater in those with non-cirrhotic alcholic liver disease.
Do not exceed the stated dose.
Not to be given to children under 12 years.
Dosage should not be continued for more than three days without consulting your doctor.
Do not take more than 8 capsules in any 24 hour period.
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 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 rare, usually mild and may include skin rashes and other allergic reactions occasionally.
Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
4.9 Overdose
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 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.
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 also 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.
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 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 preclinical 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
Magnesium stearate
Sodium starch glycolate
Sodium lauryl sulphate
Indigo Carmine E132 )
Titanium dioxide E171 ) Capsule shell
Gelatine )
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 30°C.
Store in the original package.
6.5 Nature And Contents Of Container
A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC 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.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
The Boots Company PLC
Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0442
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 15 September 1992
Date of last renewal: 15 September 1997
10. Date Of Revision Of The Text
November 2004
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