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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: Paracetamol 250mg/5ml Oral Suspension is indicated for the treatment of mild to moderate pain as an antipyretic. Including headache, toothache, earache and sore throats. It is also used to treat colds and influenza, aches and pains and post-immunisation fever.
Verbatim from this product's MHRA label. Tap a section to expand.
5 mL spoonful (small end) 4 times 10 – 12 years Two 5 mL spoonfuls (large end) 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:
Two - three 5mL spoonfuls (large end) up to 4 times a day Adults and children over 16 years: Two - four 5mL spoonfuls (large end) up to 4 times a day.
The 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 post- marketing 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 acidosis 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.
1. 3 PHARMACEUTICAL FORM Oral Suspension. White to off-white uniform suspension. 1 Therapeutic indications Paracetamol 250mg/5ml Oral Suspension is indicated for the treatment of mild to moderate pain as an antipyretic. Including headache, toothache, earache and sore throats.
It is also used to treat colds and influenza, aches and pains and post-immunisation fever. 5 mL spoonful (small end) 4 times 10 – 12 years Two 5 mL spoonfuls (large end) 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:
Two - three 5mL spoonfuls (large end) up to 4 times a day Adults and children over 16 years: Two - four 5mL spoonfuls (large end) up to 4 times a day.
The 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. 1. This product contains maltitol liquid, patients with rare hereditary problems of fructose intolerance should not take this medicine.
4 Special warnings and precautions for use 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 abusers should consult a doctor before use.
1. This product contains maltitol liquid, patients with rare hereditary problems of fructose intolerance should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acetaminophen in United Kingdom.
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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.
Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided. 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.
This product contains Sodium methyl parahydroxybenzoate (E219) and Sodium propyl parahydroxybenzoate (E217). These may cause allergic reactions (possibly delayed). It also contains maltitol liquid (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The strawberry flavour contains propylene glycol in very small amounts of 8mg of propylene glycol in 5ml. The label will include: • Contains paracetamol. • Do not give anything else containing paracetamol while giving this medicine. • For oral use only.
• Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. • Do not overfill the spoon. • Always use the spoon supplied with the pack. • 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 taking this product.
• Do not store above 25°C. Store in the original package. • Keep out of the sight and reach of children. • Shake the bottle for at least 10 seconds before use. • Talk to a doctor at once if you take too much of this medicine even if you seem well.
The leaflet shall contain the following statements:
Talk to a doctor at once if you take too much of this medicine even if you seem well. This is because too much Paracetamol can cause delayed, serious liver damage.. 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.
g. , 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.