Boots Paracetamol Capsules 500 mg

Capsules, hard.

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.

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.

Hypersensitivity to any of the ingredients. Severe liver disease.

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.

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.

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.

No adverse effects known.

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.

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.

Paracetamol is a peripherally acting analgesic with antipyretic activity.

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.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Magnesium stearate

Sodium starch glycolate

Sodium lauryl sulphate

Indigo Carmine E132 )

Titanium dioxide E171 ) Capsule shell

Gelatine )

None stated.

36 months.

Do not store above 30°C.

Store in the original package.

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.

None stated.

The Boots Company PLC

Nottingham

NG2 3AA

PL 00014/0442

Date of first authorisation: 15 September 1992

Date of last renewal: 15 September 1997

November 2004