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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: 22/07/2011
SPC Benylin Children's Chesty Coughs

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 22/07/2011 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 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   29-Apr-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Section 4.2:

Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:

Use only when simple measures have failed to provide adequate relief.

Use for more than 5 consecutive days is not recommended

Section 4.3

CI in children under 6.


Section 4.4

Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours. 

changed to:

Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours. 

 

Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:

Consult a pharmacist or other healthcare professional before use in children under 12 years.
Updated on 28/04/2011 and displayed until 22/07/2011
Reasons for adding or 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
Date of revision of text on the SPC:   27-Apr-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.2 Children aged 6 to 12 years:-  "Use only when simple measures have failed to bring adequate relief.  Use for more than 5 consecutive days is not recommended" has been added.
Section 4.2 Children aged 2 to 5 years:- This paragraph detailing method of administration has been removed.
Section 4.2 Children under 2 years:-  Has been changed to "Children under 6 years".
Section 4.2 Children under 2 years:-  "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 2 years of age, except on the advise of a physician" has been changed to "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 6 years of age".

Section 4.3 Contra-indications:-  "BENYLIN Children's Chesty Coughs is contra-indiciated in children under 6 years" has been added.

Section 4.4 Special Warnings and special Precautions for use:-  "Consult a pharmacist or other healthcare professional before use in children under 6 years" has been changed to "Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years"
 
Updated on 06/12/2010 and displayed until 28/04/2011
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Inclusion of child resistant cap.
Updated on 13/01/2010 and displayed until 06/12/2010
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   15-Dec-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Inclusion of additional 2 piece child resistant container closure system.
Updated on 02/09/2008 and displayed until 13/01/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   08/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Renewal Changes made:
 
Section 1 - Change from Benylin Children's Chesty Cough to Benylin Children's Chesty Cough 50mg/5ml Syrup
 
Section 2 - Inclusion of excipient sorbitol liquid
 
Section 6.1 - Includion of E numbers after excipients (where relevant)
Updated on 25/06/2008 and displayed until 02/09/2008
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 25/06/2008
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 21/09/2004 and displayed until 11/03/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 12/06/2003 and displayed until 21/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Guaifenesin