PARACETAMOL is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, aches and pains. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness, feverish colds.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults, the elderly and children 16 years and over:
One or two tablets to be taken up to four times daily. Maximum dose of 8 tablets in 24 hours.
Children 10 to 15 years of age:
One tablet to be taken for every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.
Children under 10 years of age:
Not recommended. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period.
Dosage should not be continued for more than 3 days without consulting a doctor. Method of administration For oral administration.
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia, neutropenia, pancytopenia, leukopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.
Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data:
Skin and subcutaneous disorders: Very rare cases of serious skin reactions have been reported.
Blood and lymphatic system disorders:
Thrombocytopenia, agranulocytosis.
Immune system disorders:
Anaphylaxis. Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis.
Respiratory, thoracic and mediastinal disorders:
Bronchospasm*. *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Hepatobiliary disorders:
Hepatic dysfunction. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase.
In such cases, the use of analgesics should be discontinued in consultation with the doctor. 9), severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day. Do not exceed the recommended dose. If symptoms persist, consult your doctor. Keep out of the sight and reach of children.
g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended.
The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors May rarely cause severe hypersensitivity reactions and bronchospasm as this medicine contains sodium metabisulphite.
The label will state the following warnings:
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.
The leaflet will state the following warnings:
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Hypersensitivity to paracetamol or any of the other ingredients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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