Panadol Actifast Tablets 500mg
*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 19 December 2024
File name
Panadol Actifast text leaflet - Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Change from GSK Dungarvan to Haleon Dungarvan
Updated on 21 March 2023
File name
ie-spc-panadol actifast-500mg-proposed-clean-Mar2023.pdf
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
Change from GSK (Ireland) Limited to Haleon Ireland Limited
Updated on 21 March 2023
File name
ie-mockup-Panadol actifast leaflet-230316SKDJ.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Change from GSK (Ireland) Limited to Haleon Ireland Limited
Updated on 20 September 2022
File name
ie-mockup-Panadol Actifast Tablets-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-panadolactifast-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 30 October 2020
File name
ie-mockup-pl-panadolactifast-10-20-200826EM.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 30 October 2020
File name
ie-spc-panadolactifast-shelf life and storage - 200826EM-approved.pdf
Reasons for updating
- 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
Legal category:Supply through general sale
Updated on 29 May 2020
File name
ie-mockup-pl-panadolactifast-200320em-proposed-mar2020.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 December 2019
File name
ie-pl-actifast 39-12-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
Updated on 19 December 2019
File name
ie-spc-panadolactifast-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 29 August 2019
File name
ie-mockup-pl-panadolactifast-190129EM.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- 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
Updated on 29 August 2019
File name
ie-spc-panadolactifast-clean-190129em.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 29 August 2019
File name
ie-spc-panadolactifast-clean-190129em-med.ie.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 10 July 2019
File name
ie-spc-panadolactifast-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-39-12.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
- 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.
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.
Updated on 19 July 2017
File name
PIL_8679_77.pdf
Reasons for updating
- New PIL for new product
Updated on 19 July 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 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 6.5 - Nature and contents of container
- 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
The lowest dose necessary to achieve efficacy should be used.
4.4 Special warnings and precautions for use
Contains paracetamol. Do not use 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.
If you have been diagnosed with liver or kidney impairment, seek medical advice before taking this medication
Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Patients should be advised not to take other paracetamol-containing products concurrently.
4.9 Overdose
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.
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.
6.5 Nature and contents of container
perforated opaque PVC/Aluminium foil blister strips
10. Date of Revision of the Text
April 2017
The lowest dose necessary to achieve efficacy should be used.
4.4 Special warnings and precautions for use
Contains paracetamol. Do not use 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.
Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
4.9 Overdose
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.
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.
6.5 Nature and contents of container
perforated opaque PVC/Aluminium foil blister strips
10. Date of Revision of the Text
April 2017
Updated on 12 April 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 15 April 2016
Reasons for updating
- Change to MA holder contact details
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 14 June 2011
Reasons for updating
- Change to improve clarity and readability
Updated on 06 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Change due to user-testing of patient information
Updated on 29 January 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2
the following sentence is added:
Maximum duration of continued use without medical advice: 3 days.
Section 4.8
Adverse events presented by System Organ Classification and frequences
the following sentence is added:
Maximum duration of continued use without medical advice: 3 days.
Section 4.8
Adverse events presented by System Organ Classification and frequences
Updated on 20 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 30 May 2007
Reasons for updating
- Change of inactive ingredient
Updated on 29 March 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
2. Qualitative and Quantitative Composition
New sentence: Excipients: Contains 173mg (7.5mmol) sodium per tablet.
Update sentence: For a full list of excipients see Section 6.1
6.1 List of Excipients
Replace sodium bicarbonate with Sodium hydrogen carbonate
6.5 Nature and Contents of Container
New sentence: Not all pack sizes are marketed.
Updated on 01 November 2006
Reasons for updating
- Improved electronic presentation
Updated on 23 May 2006
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Updated on 13 April 2006
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through general sale
Updated on 16 August 2005
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 04 August 2005
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Supply through general sale
Updated on 06 July 2005
Reasons for updating
- Change to dosage and administration
Updated on 12 May 2005
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Updated on 23 December 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 24 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 20 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Haleon Ireland Limited
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandMedical Information Direct Line:
1800 441 442