Panadol Actifast Tablets 500mg

  • Name:

    Panadol Actifast Tablets 500mg

  • Company:
    info
  • Active Ingredients:

    Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/10/20

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Summary of Product Characteristics last updated on medicines.ie: 30/10/2020

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Address: 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line: 1800 441 442

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1 - 0 of 59 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 30 October 2020 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 30 October 2020 SPC

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 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 19 December 2019 PIL

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 SPC

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 PIL

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Updated on 19 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 July 2017 PIL

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 PIL

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 12 April 2017 SPC

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

Updated on 15 April 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015 SPC

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 6 August 2010 PIL

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 SPC

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

Updated on 20 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 30 May 2007 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 29 March 2007 SPC

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 1 November 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 May 2006 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Updated on 13 April 2006 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through general sale

Updated on 16 August 2005 SPC

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 4 August 2005 SPC

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 6 July 2005 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 12 May 2005 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 August 2003 SPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 27 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale