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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/08/2010
SPC Triapin & Triapin Mite

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 18/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Minor changes to Sections 1, 4.2, 4.3, 4.4, 10

 

4.1 – addition of ‘Triapin mite does not represent a treatment of choice for primary hyperaldosteronism.’

 

4.6 – Lactation - existing text deleted, added ‘Because insufficient information is available regarding the use of ramipril during breastfeeding and felodipine is excreted in human breast-milk.  Triapin mite/Triapin is not recommended and alternative treatment with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.’

 

4.8 – Addition of definitions of frequency of adverse events. Reclassified some events by frequency, removal of ‘laymans terms’ from table e.g. pyrexia (fever) now states just ‘pyrexia.’
Updated on 18/03/2009 and displayed until 18/08/2010
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   01-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of black triangle
Updated on 28/03/2008 and displayed until 18/03/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 10 (Date of revision of text): January 2008
Updated on 14/03/2008 and displayed until 28/03/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section2  Qualitative and Quantitative Composition

Triapin Mite: Each tablet contains 2.5 mg of felodipine and 2.5 mg of ramipril.

            Each tablet contains 52 mg lactose anhydrous.

 

            Triapin: Each tablet contains 5 mg of felodipine and 5 mg of ramipril.

            Each tablet contains 51.5 mg lactose anhydrous.
 
Section 4.8: undesirable effects - re-arrangement of side effects tables
 
Section 10: date of revision of text
January 2007
 
 
Updated on 06/06/2007 and displayed until 14/03/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
MA holder has been changed to sanofi-aventis.
Updated on 30/09/2004 and displayed until 06/06/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 24/05/2002 and displayed until 30/09/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  felodipine
  ramipril