Panadol Cold and Flu Relief 500mg/65mg Film Coated Tablets

  • Name:

    Panadol Cold and Flu Relief 500mg/65mg Film Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Caffeine, Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/18

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2018

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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Medicine Name Night Nurse Capsules Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
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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 3 September 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 3 September 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Paediatric posology changes

Updated on 21 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 21 July 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

An update to section 4.4 to include a warnings and precautions statement concerning risk of metabolic acidosis in patients in glutathione depleted states, such as sepsis.

 

An update to sections 4.2, 4.4 and 4.9 to include further information relating to hepatotoxicity associated with overdose, and hepatic dysfunction in glutathione depleted states.

An update of the date of revision in section 10.

Updated on 21 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 18 April 2017 SmPC

Reasons for updating

  • 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

4.4 Special warnings and precautions for use

Underlying liver disease increases the risk of paracetamol related liver damage.


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 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 15 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 Addition of statement regarding reporting of suspected adverse reactions
Section 9 Addition of renewal date

Updated on 14 May 2015 PIL

Reasons for updating

  • Change to storage instructions
  • Addition of information on reporting a side effect.

Updated on 16 December 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

As ink is no longer used to print on the tablets, the list of ingredients that make up the ink has been removed to both sections concerned.

Updated on 12 December 2013 PIL

Reasons for updating

  • Change to packaging

Updated on 11 April 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.8:Skin rashes added.

Updated on 9 August 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 10 May 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Sectin 4.4
Addition of the warning in relation to exessive intake of caffeine and update of the warning related to people who have been diagnosed with liver and kidney imparament.

Sectin 4.6
Updated to show information related to pregnancy and breastfeeding for both actives, paracetamol and caffeine.

Sectin 4.8
Adverse events showed in the table by System Organ Class together with the frequences. 

Sectin 4.9
Addition of the paragraph related to an overdose with caffeine 

Updated on 13 August 2009 PIL

Reasons for updating

  • Change to date of revision

Updated on 20 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through general sale

Updated on 22 June 2007 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 June 2007 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale