BOOTS 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: Indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral use only. It is important to shake the bottle for at least 10 seconds before use. 5ml) 4 times 10-12 years 10 ml (5ml + 5ml) 4 times Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
Do not give to children under the age of 6 years. Children aged 12-16 years: 10-15 ml (Two to three 5 ml doses) up to 4 times a day. Adults and children over 16 years: 10-20 ml (Two to four 5 ml doses) up to 4 times a day.
Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
Adverse drug reactions (ADRs) identified during clinical trials and postmarketing experience with paracetamol are listed below by System Organ Class (SOC).
The frequencies are defined according to the following convention:
Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence is unavailable, frequency category is listed as ‘Not known’.
System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Blood and lymphatic system disorders Not known Blood disorder (including thrombocytopenia and agranulocytosis)1 Very rare Anaphylactic reactionImmune system disorders Very rare Hypersensitivity Hepatobiliary disorders Not known Liver injury2 Very rare Rash Not known Fixed eruption Not known Rash pruritic Skin and subcutaneous tissue disorders Not known Urticaria Uncommon Nephropathy toxicRenal and urinary disorders Not known Renal papillary necrosis3 Investigations Not known Transaminases increased4 Metabolism and nutrition disorders Not known High anion gap metabolic acidosis5 1 Reported following paracetamol use, but not necessarily causally related to the drug 2 Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year 3 Reported after prolonged administration 4 Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients Very rare cases of serious skin reactions have been reported. Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.
Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs or symptoms are not noticed.
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. Chronic alcohol users should consult a doctor before use.
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 the underlying cause of HAGMA in patients with multiple risk factors. Glutathione deficiency can also increase the risk of hepatotoxicity with paracetamol use, even at therapeutic doses.
9). Hepatotoxicity at therapeutic dose Cases of paracetamol induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetamol at doses within the therapeutic range. These cases were reported in patients with one or more risk factors for hepatotoxicity including low body weight (adults <50 kg), renal and hepatic impairment, chronic alcoholism, concomitant intake of hepatotoxic drugs and in acute and chronic malnutrition (low reserves of hepatic glutathione).
Paracetamol should be administered with caution to patients with these risk factors. 9). Dosage adjustment of paracetamol should be considered where there are risk factors for glutathione deficiency or hepatotoxicity and for those of low weight (for adults those weighing less than 50kg).
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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A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
This medicine should not be diluted. Where a dilution of this medicine is required, Paracetamol 120mg/5ml Oral Suspension should be recommended. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided.
The label will state:
Do not give anything else containing paracetamol while giving this medicine. Do not give more medicine than the label tells you to. If your child does not get better, talk to their doctor. Talk to a doctor at once if your child takes too much of this medicine, even if they seem well Keep out of the reach and sight of children.
The label should convey the following information:
For oral use only. Never give more medicine than shown in the table. Always use the syringe supplied with the pack. Do not give to children under 6 years of age. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before giving this product.
Do not store above 25°C. Store in the original package. Shake the bottle for at least 10 seconds before use.
The leaflet will state:
Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage If the child needs more than the doses shown in the table, or if fever doesn’t go away, speak to your doctor as soon as possible.
Very rare cases of serious skin reactions have been reported. Symptoms may include: - Skin reddening - Blisters - Rash If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away. 1g of sorbitol in each 5ml dose, which is equivalent to 220mg/ml.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicine. Methyl hydroxybenzoate (E218) may cause allergic reactions (possible delayed).
012mg/ml. Benzyl alcohol may cause allergic reactions. High volumes should be used with caution and only if necessary, especially in patients who are pregnant or breast-feeding or subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
56mg/ml. This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.