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CALPOL SIX PLUS FASTMELTS 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: Calpol Six Plus Fastmelts is 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.
Oral:
Tablets should be placed in the mouth where they melt on the tongue. The tablet will rapidly disperse to a pleasant tasting paste that can be easily ingested. Alternatively the tablet can be dispersed in a teaspoonful of water or milk.
Adults and children Child’s Age How Much How often (in 24 hours) Under 6 years Not recommended N/A 6 - 9 years 1 tablet 4 times 9 - 12 years 2 tablets 4 times 12 – 16 years 2 to 3 tablets 4 times Adults and children over 16 years 2 to 4 tablets 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 Use in the Elderly Normal adult dosage is appropriate.
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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 reactionsImmune 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.
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 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 underlying cause of HAGMA in patients with multiple risk factors. 04 mg/250 mg tablet. The phenylalanine in the tablets may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Calpol Six Plus Fastmelts contain mannitol, which may have a mild laxative effect. 0011 g of glucose in each tablet. Patients with rare glucose-galactose malabsorption should not take this medicine. 00064 mg benzyl alcohol in each tablet.
Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have a liver or kidney disease. " 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.
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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 their disease improved after paracetamol withdrawal.
High anion gap metabolic acidosis. 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.
The label contains the following statements:
Contains paracetamol. 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 your doctor. For oral use only 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 other medicine consult your doctor or pharmacist before using this product.
Keep out of the sight and reach of children. Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.
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.