Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg

Product Information *

  • Company:

    Reckitt Benckiser Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through general sale

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 15 January 2020

File name

Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg_1579099056.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 17 February 2017

File name

PIL_14949_823.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 February 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • 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
  • Improved presentation of PIL

Updated on 01 December 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.2:
Additional information added in relation to posology, hepatic and renal impairment, elderly population, method of administration and use with other paracetamol containing products.

Section 4.3:
Addition of hypersensitivity contraindications

Section 4.4:
Addition of data in relation to Serious skin reactions, hepatitis, non-cirrhotic alcohol liver disease, hepatic and renal insufficiency.  Excipient warning added in relation to aspartame and phenylalanine.

Section 4.5:
Addition of interactions with anticoagulants, antiemetics, cholestyramine, and laboratory interference.

Section 4.6:
Additional data in relation to pregnancy and breast-feeding.

Section 4.8:
MedDRA table added and undesirable effects added in relation to blood and lymphatic system disorders, gastrointestinal disorders and skin & subcutaneous tissue disorders.
Addition of Reporting of Suspected Adverse Reactions paragraph.

Section 4.9:
Rewording of paragraph to include additional information on paracetamol overdosage

Section 5.1:
Addition of pharmacodynamics properties in relation to Guaifenesin.


 
  

Updated on 01 December 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 21 April 2016

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

Addition of Lactose added to excipients

Lactose warning added to SmPC

Updated on 04 August 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 22 July 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

The SmPC has been updated as part of renewal. Excipients have been updated in composition section. Update to safety information as a result of renewal

Updated on 30 March 2011

Reasons for updating

  • 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 10, revison of text date May 2008 added

Updated on 30 March 2011

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 October 2007

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale