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McNeil Healthcare (Ireland) Ltd

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: 21/07/2011
SPC Actifed Syrup

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 21/07/2011 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.

 

changed to:
Updated on 07/10/2008 and displayed until 21/07/2011
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 25/08/2008 and displayed until 07/10/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.

Updated on 31/03/2008 and displayed until 25/08/2008
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

Section 7.
 
New MA holder: McNeil Helathcare (Ireland) Ltd. Airton road, Tallaght, Dublin 24, Ireland.
Updated on 11/03/2008 and displayed until 31/03/2008
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 18/01/2005 and displayed until 11/03/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Updated on 21/09/2004 and displayed until 18/01/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 18/08/2003 and displayed until 21/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Pseudoephedrine Hydrochloride
   triprolidine hydrochloride

Versions

 
21/07/2011 to Current
07/10/2008 to 21/07/2011
25/08/2008 to 07/10/2008
31/03/2008 to 25/08/2008
11/03/2008 to 31/03/2008
18/01/2005 to 11/03/2008
21/09/2004 to 18/01/2005
18/08/2003 to 21/09/2004
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  • Contact Us

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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