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McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 11/09/2009
SPC Benylin Dual Action Chesty

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 11/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Section 4.2:

Indication for use in children under 12 removed.

Section 4.3:

Contraindication not to use in children under 12 added.

Section 10:

Changed to July 2009
Updated on 07/10/2008 and displayed until 11/09/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   10/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Change from "Plastic" to "HDPE"
Updated on 09/09/2008 and displayed until 07/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   09/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Update of section 4.4 of SPC - addition of sucrose / fructose warning

Update of section 5.1 of SPC - addition of ATC code.
Updated on 24/06/2008 and displayed until 09/09/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   06/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Added to section 4.4;
 

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children under 6 years.
Updated on 11/03/2008 and displayed until 24/06/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24
Updated on 23/01/2008 and displayed until 11/03/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
 
Additonal list of excipients has been included in this section:

Each 5ml of syrup contains 30mg  Pseudoephedrine hydrochloride and 100 mg Guaifenesin
 
 
            Excipients: Also includes Sucrose 3g per 5ml, Sunset yellow (E110) 0.25mg per 5ml, Ponceau 4R (E124) 0.25mg per 5ml. Methyl hydroxybenzoate (E218) 5.0mg per 5ml, Propyl hydroxybenzoate (E216) 0.5mg per 5ml and ethanol (96%) 0.25ml per 5ml.
Updated on 24/02/2006 and displayed until 23/01/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Guaifenesin
  Pseudoephedrine Hydrochloride