Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral Solution

  • Name:

    Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral Solution

  • Company:
    info
  • Active Ingredients:

    Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/01/17

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Summary of Product Characteristics last updated on medicines.ie: 29/11/2016
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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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 18 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 18 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 2016 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 4.9 - Overdose

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4:
Deletion of warning "if symptoms persist, the physician should be consulted"
Addition of warning "if symptoms persist for more than seven days, please consult a healthcare professional"

Section 4.6:
Deletion of "For short term use in all trimesters of pregnancy.  There is epidemiological evidence of safety in human pregnancy.  Patients should follow the advice of their doctor regarding the use of paracetamol during pregnancy".
Addition of "A large amount of data on pregnancy women indicate neither malformative, nor feto/neonatal toxicity.  paracetamol can be used during pregnancy If clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency".

Section 4.9:
Addition of new data in relation to risk factors, symptoms and overdose management.

Updated on 29 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 10 August 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 30 January 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 2 - added Lactose to list of excipients

Section 4.4 - added warning regarding presence of Lactose

Section 6.1 - added to list of excipients: Lactose, polysorbate 80, and Silica

Section 10 - Changed date of revision of text to January 2014

Updated on 30 March 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 October 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 1: Strengh and form included in name
Section 9: change date of ast renewal

Updated on 15 May 2007 SmPC

Reasons for updating

  • Change to marketing authorisation holder address

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

SECTION 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Updated on 29 August 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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

Free text change information supplied by the pharmaceutical company

Section 1: Trade Name - Should be Lemsip Cold & Flu Hot Lemon
 
Section 2: Qualitative and Quantitative Composition - Remove Ascorbic acid and Sodium citrate as actives
 
Section 4.4: Special Warnings and special precautions for use - Amount of carbohydrate in point 3 should be changed from 4.15g to 3g
 
Section 6.1 - List of excipients - Needs changing completely to : Sucrose, citric acid, Lemon flavour no.1, saccharin sodium, aspartame, sodium citrate, ascorbic acid and curcumin WD
 
Section 6.4 - Special precautions for storage - need to change 30°C to 25°C
 
Section 6.5 - Nature and contents of container - the words Surlyn laminate need changing to heat seal laminate
 
Section 10 - Date of (partial) Revision of the Text - should be April 2006

Updated on 19 May 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 10 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale