Panadol Baby 120mg/5ml Oral Suspension
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company

Updated on 30 June 2023
File name
IE-SPC-PanadolBaby-Separation-clean-230630RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 30 June 2023
File name
ie-text leaflet-PanadolBaby-Separation-clean-230630RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Update to Haleon information
Updated on 19 December 2022
File name
ie-text leaflet-PanadolBaby-IronMan reformulation-approved 14-12-2022.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 December 2022
File name
IE-SPC-PanadolBaby-Ironman Formulation-approved 14th December 2022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 19 December 2022
File name
ie-spc-panadolbaby-PRAC update-clean-220511SKDJ.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 20 September 2022
File name
ie-mockup-panadol baby-proposed-220511SKDJ.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-panadolbaby-PRAC update-clean-220511SKDJ.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Supply through general sale
Updated on 11 May 2020
File name
ie-spc-panadolbaby-additionofnyon-200219EM APPROVED 6th May 2020.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 16 April 2020
File name
ie-mockup-pl-panadolbaby-39-3 171007ATR.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 December 2019
File name
ie-pl-baby 39-3-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
Updated on 19 December 2019
File name
ie-spc-panadolbaby-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through general sale
Updated on 15 July 2019
File name
m1-3-1-PIL-150102REH-GDSv3-baby_1.pdf
Reasons for updating
- New PIL for new product
Updated on 10 July 2019
File name
ie-spc-panadolbaby-PRAC APAP-190708EM-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 09 August 2018
File name
ie-spc-clean-39-3.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Updated on 20 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 20 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 20 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 20 July 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.
Updated on 20 July 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.
Updated on 11 April 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
In section 4.2, addition of:
The lowest dose necessary to achieve efficacy should be used.
In section 4.4, addition of:
Contains paracetamol. Do not give with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.
In section 4.4, deletion of:
Do not give with any other paracetamol-containing products.
In section 4.9, addition of:
Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
There is a risk of poisoning with paracetamol particularly in elderly subjects, young children, patients with liver disease, cases of chronic alcoholism and in patients with chronic malnutrition. Overdosing may be fatal in these cases.
Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.
Overdose of paracetamol in a single administration in adults or in children can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.
Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Some patients may be at increased risk of liver damage from paracetamol toxicity.
Risk Factors include: If the patient;
• Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
• Regularly consumes ethanol in excess of recommended amounts
• Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia
Emergency Procedure:
Immediate transfer to hospital.
Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion.
Administration of activated charcoal should be considered if >150mg/kg paracetamol has been taken within 1 hour.
The antidote N-acetylcysteine, should be administered as soon as possible in accordance with National treatment guidelines
Symptomatic treatment should be implemented.
In section 4.9, deletion of:
Immediate medical attention (in-hospital, if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12 g paracetamol (24 standard 500 mg tablets) or more than 150 mg paracetamol per kg
bodyweight (9 g paracetamol in a 60 kg individual), whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose.
Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.
Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death.
Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
In section 10, updated date:
March 2017
Updated on 11 April 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2, addition of:
The lowest dose necessary to achieve efficacy should be used.
In section 4.4, addition of:
Contains paracetamol. Do not give with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.
In section 4.4, deletion of:
Do not give with any other paracetamol-containing products.
In section 4.9, addition of:
Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
There is a risk of poisoning with paracetamol particularly in elderly subjects, young children, patients with liver disease, cases of chronic alcoholism and in patients with chronic malnutrition. Overdosing may be fatal in these cases.
Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.
Overdose of paracetamol in a single administration in adults or in children can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.
Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Some patients may be at increased risk of liver damage from paracetamol toxicity.
Risk Factors include: If the patient;
• Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
• Regularly consumes ethanol in excess of recommended amounts
• Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia
Emergency Procedure:
Immediate transfer to hospital.
Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion.
Administration of activated charcoal should be considered if >150mg/kg paracetamol has been taken within 1 hour.
The antidote N-acetylcysteine, should be administered as soon as possible in accordance with National treatment guidelines
Symptomatic treatment should be implemented.
In section 4.9, deletion of:
Immediate medical attention (in-hospital, if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12 g paracetamol (24 standard 500 mg tablets) or more than 150 mg paracetamol per kg
bodyweight (9 g paracetamol in a 60 kg individual), whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose.
Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.
Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death.
Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
In section 10, updated date:
March 2017
Updated on 10 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 10 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 30 June 2015
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
update to section 6.1 (list of excipients) to replace proprietary ‘Nipasept’ blend with the individual parabens
Updated on 30 June 2015
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
update to section 6.1 (list of excipients) to replace proprietary ‘Nipasept’ blend with the individual parabens
Updated on 01 December 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
This product is intended for oral use in children ages:
Age : 2 – 3 months |
Dose |
1. Post-vaccination fever |
One 2.5 mL measure If necessary, after 4-6 hours, give a second 2.5 mL dose |
2. Other causes of Pain and Fever only if · Weighs over 4 kg · Born after 37 weeks |
|
|
How Much |
How often (in 24 hours) |
|
3 – 6 months |
One 2.5 mL measure |
4 times |
6 – 24 months |
One 5 mL spoonful |
4 times |
2 – 4 years |
One 5ml spoonful and one 2.5 mL measure |
4 times |
4 – 8 years |
Two 5mL spoonfuls |
4 times |
8 – 10 years |
Three 5mL spoonfuls |
4 times |
10 – 12 years |
Four 5mL spoonfuls |
4 times |
|
It is important to shake the bottle for at least 10 seconds before use
If your baby was born prematurely and is less than 3 months old consult your
doctor prior to use.
Method of Administration
Panadol Baby suspension is for oral administration only.
4.4 Special Warnings and precautions for use
Always use the spoon supplied with the pack.
Updated on 01 December 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
This product is intended for oral use in children ages:
Age : 2 – 3 months |
Dose |
1. Post-vaccination fever |
One 2.5 mL measure If necessary, after 4-6 hours, give a second 2.5 mL dose |
2. Other causes of Pain and Fever only if · Weighs over 4 kg · Born after 37 weeks |
|
|
How Much |
How often (in 24 hours) |
|
3 – 6 months |
One 2.5 mL measure |
4 times |
6 – 24 months |
One 5 mL spoonful |
4 times |
2 – 4 years |
One 5ml spoonful and one 2.5 mL measure |
4 times |
4 – 8 years |
Two 5mL spoonfuls |
4 times |
8 – 10 years |
Three 5mL spoonfuls |
4 times |
10 – 12 years |
Four 5mL spoonfuls |
4 times |
|
It is important to shake the bottle for at least 10 seconds before use
If your baby was born prematurely and is less than 3 months old consult your
doctor prior to use.
Method of Administration
Panadol Baby suspension is for oral administration only.
4.4 Special Warnings and precautions for use
Always use the spoon supplied with the pack.
Updated on 11 April 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 11 April 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 29 January 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
warning re: malitol and sorbitol is added
Section 4.8
Adverse events sorted by System Organ Classification and frequencies
Updated on 29 January 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
warning re: malitol and sorbitol is added
Section 4.8
Adverse events sorted by System Organ Classification and frequencies
Updated on 24 August 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 5.1 - Correction of ATC code.
Section 6.1 - Addition of components of preservative mixture.
Section 10 - Updated revision of text.
Updated on 24 August 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 5.1 - Correction of ATC code.
Section 6.1 - Addition of components of preservative mixture.
Section 10 - Updated revision of text.
Updated on 11 June 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update section 4.6 - Addition of text
Update section 4.8 - Addition of an undesirable effect
Update section 5.1 - Addition of ATC code
Updated on 11 June 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Free text change information supplied by the pharmaceutical company
Update section 4.6 - Addition of text
Update section 4.8 - Addition of an undesirable effect
Update section 5.1 - Addition of ATC code
Updated on 21 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 21 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 30 July 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
section 1 - name of product changed (also updated in all other sections)
section 2 - quantities of some excipients included
section 6.5 - reference to measuring spoon included
section 9 - date of last renewal changed & 'th' deleted from dates
section 10 - date of revision changed
Updated on 30 July 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
section 1 - name of product changed (also updated in all other sections)
section 2 - quantities of some excipients included
section 6.5 - reference to measuring spoon included
section 9 - date of last renewal changed & 'th' deleted from dates
section 10 - date of revision changed
Updated on 07 August 2007
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 07 August 2007
Reasons for updating
- Improved electronic presentation
Updated on 05 August 2004
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 05 August 2004
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Updated on 12 May 2004
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through general sale
Updated on 12 May 2004
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Updated on 19 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 19 August 2003
Reasons for updating
- Improved electronic presentation
Updated on 12 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 12 August 2003
Reasons for updating
- Improved electronic presentation
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Haleon Ireland Limited
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandMedical Information Direct Line:
1800 441 442