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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 07/09/2011
SPC Lemsip Chesty Cough 50 mg/5 ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, 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 07/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

Section 2, "Each 5ml of oral solution contains 4g of sucrose" has been added.

Section 4.2 Indication in under 12s removed and "Not recommended for children under 12 years" added.

Section 4,3 "Contraindicated in children under 12 years of age" added.

Section 4.4 " Not recommended for children under 12 years" added and "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine."
Updated on 04/03/2009 and displayed until 07/09/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   08/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

Update to section 4.2 & 4.4
 
Restriction of use in children under 2 years, increased warnings for use in children aged 2-6 years.
Updated on 27/08/2007 and displayed until 04/03/2009
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Guaifenesin

Versions

 
07/09/2011 to Current
04/03/2009 to 07/09/2011
27/08/2007 to 04/03/2009
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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