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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 08/02/2010
SPC Frumil Low Strength 20mg/2.5mg Tablets

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 08/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update sections 4.4 and 4.5 in relation to use with risperidone.
Updated on 07/01/2009 and displayed until 08/02/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
update sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9
Updated on 04/09/2008 and displayed until 07/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/08/2007 and displayed until 04/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.3    Additional Contraindications
Section 4.4    Additional warnings
Section 4.7    Changed to include warning
Section 10     Updated to November 2006
Updated on 13/12/2006 and displayed until 27/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision
Updated on 04/09/2006 and displayed until 13/12/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

Active Ingredients

 
  Amiloride Hydrochloride
  Furosemide