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Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 17/06/2011
SPC Anafranil 50mg Capsules

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 17/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   15-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 6.5 - the packaging was corrected to state PVC/PVDC/Aluminium - the PVDC material had previously been omitted in error.
Updated on 12/07/2010 and displayed until 17/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02-Jul-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Updated section 4.8 of SPC to include class safety warning on risk of bone fractures in patients receiving SSRI's and TCA's, at request of Pharmacovigilence dept of IMB.
Updated on 11/05/2010 and displayed until 12/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   26-Feb-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Changes were made to SPC sections in order to bring into line with QRD template wording, following renewal application
Updated on 25/11/2009 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   19-Nov-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Added the following to section 4.5:
"Oral antifungal, terbinafine. Coadministration of Anafranil with terbinafine, a strong inhibitor of CYP2D6, may result in increased exposure and accumulation of clomipramine and its N-demethylated metabolite. Therefore, dose adjustments of Anafranil may be necessary when coadministered with terbinafine "
Updated on 05/03/2009 and displayed until 25/11/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special Warnings and Precautions for Use) and Section 4.8 (Undesirable Effects) have been update to include information relating to suicide/suicidal warning or clinical worsening
Updated on 08/01/2008 and displayed until 05/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   12/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Updates to Section 4.4, 4.8, 6.1
Updated on 29/08/2006 and displayed until 08/01/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 
 
The SPC has been updated
Updated on 15/08/2006 and displayed until 29/08/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   10/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
  The SPC has been updated
Updated on 06/06/2003 and displayed until 15/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Clomipramine hydrochloride