Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.
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.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect. Each 5 ml of this product contains 0.45 g sorbitol liquid. It has a calorific value of 2.6 kcal/g sorbitol.
Due to the presence of sucrose and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).
Carmoisine (E122) may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.
This medicine contains 13.63mg propylene glycol (E1520) in each 5ml dose, which is equivalent to 2.73mg/ml.
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 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.
Always use the syringe supplied with the pack.
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.
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.
Do not store above 25°C. Keep bottle in the outer carton.
It is important to shake the bottle for at least 10 seconds before use.
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:
If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
Metabolism of paracetamol possibly accelerated by carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone (also isolated reports of hepatotoxicity).
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual’s ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
When given to the mother in therapeutic doses (1 g single dose), paracetamol crosses the placenta into foetal circulation as early as 30 minutes after ingestion and is metabolised in the foetus by conjugation with sulfate and increasingly with glutathione.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
There is no information relating to the effects of this medicine on fertility.
None known.
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 |
| Skin and Subcutaneous Tissue disorders | Very rare Not known Not known Not known | Rash Fixed eruption Rash pruritic Urticaria |
| Renal and urinary disorders | Uncommon Not known | Nephropathy toxic Renal papillary necrosis3 |
| Investigations | Not known | Transaminases increased4 |
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. 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 suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
None known.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
