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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 Cough & Colds

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 02/02/2011 and displayed until 22/07/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Changes to sections 4.5 and 4.6 in line with the company core data sheet.
Updated on 19/02/2010 and displayed until 02/02/2011
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   29-Jan-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Additional child resistant 2-piece cap registered.
Updated on 09/04/2009 and displayed until 19/02/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   03/2009
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Renewal Changes:
Change to section 1 - trade name, Change to section 2 - qualitative and quantitative composition, Change to section 6.1 - List of Excipients, Change to section 6. 5 - Nature and Contents of Container, Change to section 9 - Date of Renewal of Authorisation
Updated on 23/06/2008 and displayed until 09/04/2009
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 23/06/2008
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

To change the MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.
Updated on 29/10/2004 and displayed until 11/03/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 15/09/2004 and displayed until 29/10/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 16/06/2003 and displayed until 15/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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