Panadol Baby 120mg/5ml Oral Suspension

  • Name:

    Panadol Baby 120mg/5ml Oral Suspension

  • Company:
    info
  • Active Ingredients:

    Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/12/19

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Summary of Product Characteristics last updated on medicines.ie: 19/12/2019

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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1 - 0 of 53 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19 December 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 July 2019 SmPC

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 9 August 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 20 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 20 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 20 July 2017 SmPC

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 4.4, addition of warning regarding metabolic acidosis.
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.

Updated on 20 July 2017 PIL

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 4.4, addition of warning regarding metabolic acidosis.
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.

Updated on 11 April 2017 PIL

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 11 April 2017 SmPC

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 10 July 2015 SmPC

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 PIL

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 PIL

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 30 June 2015 SmPC

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 1 December 2011 PIL

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

  • Do not give to babies less than 2 months of age
  • Do not give more than 2 doses
  • Leave at least 4 hours between doses
  • If further doses are needed, talk to your doctor or pharmacist

 

                                                           

Child’s Age

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

  • 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

 

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 1 December 2011 SmPC

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

  • Do not give to babies less than 2 months of age
  • Do not give more than 2 doses
  • Leave at least 4 hours between doses
  • If further doses are needed, talk to your doctor or pharmacist

 

                                                           

Child’s Age

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

  • 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

 

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 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 4.4 Added "Contains propylparahydroxybenzoates which may cause allergic reactions (possibly delayed)."

Updated on 11 April 2011 SmPC

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

Section 4.4 Added "Contains propylparahydroxybenzoates which may cause allergic reactions (possibly delayed)."

Updated on 29 January 2010 PIL

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

Section 4.4
warning re: malitol and sorbitol is added

Section 4.8
Adverse events sorted by System Organ Classification and frequencies

Updated on 29 January 2010 SmPC

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

Section 4.4
warning re: malitol and sorbitol is added

Section 4.8
Adverse events sorted by System Organ Classification and frequencies

Updated on 24 August 2009 SmPC

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 4.4 - addition of "and sight" warning for storage. Warning now reads "Keep out of reach and sight of chilildren."
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 PIL

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 4.4 - addition of "and sight" warning for storage. Warning now reads "Keep out of reach and sight of chilildren."
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 SmPC

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 4.4 - Addition of text
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 PIL

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 4.4 - Addition of text
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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 August 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 30 July 2008 PIL

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 30 July 2008 SmPC

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 7 August 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 7 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 August 2004 PIL

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 5 August 2004 SmPC

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 12 May 2004 SmPC

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 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Updated on 19 August 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 12 August 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 26 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie