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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: 14/05/2010
SPC Frumil 40mg/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 14/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Addition of SJS & TEN to Section 4.8
Updated on 10/02/2010 and displayed until 14/05/2010
Reasons for adding or updating:
  • 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
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 10/02/2010
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 29/04/2008 and displayed until 04/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 4.3 Contraindications
Updated on 27/08/2007 and displayed until 29/04/2008
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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.3    Additional Contraindications
Section 4.4    Additional warnings
Section 4.6    Reworded to advise use in pregnancy only if considered essential by physician
Section 4.7    Changed to include warning
Section 6.1    The term 'Aerosil' removed from Colloidal anhydrous silica
Section 6.3    Summarised to '3 years'
Section 7       Changed name of MA holder to sanofi-aventis
Section 9       Inserted subheadings
Section 10     Updated to March 2007
Updated on 04/09/2006 and displayed until 27/08/2007
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   05/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Submission of individual SPC.
Previously combined SPC.
Update to Section 4.4 - Interactions divided into three categories.
Update to Section 4.8 - Undesirable Effects grouped per organ class
Updated on 04/09/2006 and displayed until 04/09/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Amiloride Hydrochloride
  Furosemide