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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: For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. For the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu.
Verbatim from this product's MHRA label. Tap a section to expand.
5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
5 mL spoonful (small end). 5 mL dose • Do not give to babies less than 2 months of age • Leave at least 4 hours between doses • Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed.
If your child is still feverish after two doses, talk to your doctor or pharmacist. 5 mL spoonful (small end) 4 times 4 – 8 years Two 5 mL spoonfuls (large end) 4 times 8 – 10 years Three 5 mL spoonfuls (large end) 4 times 10 - 12 years Four 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 Method of administration For oral administration only It is important to shake the bottle for at least 10 seconds before use.
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 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from 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 Immune System Disorders Very rare Very rare Anaphylactic reaction 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 Renal and urinary disorders Uncommon Nephropathy toxic 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.
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 and symptoms are not noticed.
Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided. 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 underlying cause of HAGMA in patients with multiple risk factors.
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. The label contains the following statements: • Contains paracetamol.
• Do not give with any other paracetamol-containing products. • For oral use only. • Never give more medicine than shown in the table. • Always use the spoon supplied with the pack. Do not overfill the spoon. • Do not give to babies less than 2 months of age.
• For infants 2-3 months no more than 2 doses should be given. • 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.
1. Patients with severe hepatic dysfunction.
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.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.
• 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. Protect from light. Store in the original package. • Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed serious liver damage.
• If symptoms persist consult your doctor. • Keep out of the sight and reach of children. The leaflet contains the following statements: • 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. • 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.
Excipients in the formulation This product contains: • Methyl and propyl hydroxybenzoates. These may cause allergic reactions (possibly delayed). • Sucrose (3g per 5ml dose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
• Sorbitol. 0mg per 5ml dose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. 6kcal/g sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. • Propylene Glycol. 4mg propylene glycol per 5ml dose.
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old. While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk.
As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis. Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.