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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 10/01/2018
SPC Januvia 25mg, 50mg, 100mg film-coated 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 10/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Dec-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Changes to section 4.2, 4.4, 5.2 &10.0 in order to redefine mild, moderate, and severe renal impairment based on eGFR instead of CrCl.

Updated on 11/08/2017 and displayed until 10/01/2018
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to section 4.4: add Bullous pemphigoid as a warning
Updated on 04/03/2016 and displayed until 11/08/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Jan-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

SPC sections which have changed: 4.2, 4.8, 5.1, 10.0

Reasons for submission: Type II, TECOS cardiovascular safety study (WS846)


Updated on 06/08/2015 and displayed until 04/03/2016
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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:   25-Jun-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Detailed SPC change information:
Change to Section 4.8 - Undesirable effects 
Change to Section 5.1 - Pharmacodynamic properties

         Change to Section 9 - Date of renewal of authorisation

         Change to Section 10 - Date of revision of the text 
         Reasons for submission: Approval  of WS741 (addition of pruritus to side effects)

Updated on 06/07/2015 and displayed until 06/08/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-May-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to Section 4.8 - Undesirable effects
Updated on 13/04/2015 and displayed until 06/07/2015
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-Mar-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

To align the JANUVIA SmPC following the outcome of renewal procedure for Januvia duplicate product Ristaben (R-33)
Updated on 21/11/2014 and displayed until 13/04/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   30-Sep-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



ChanChange to Section 4.4 - Special warnings and precautions for use to update the product information that the use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis

 

Updated on 11/07/2014 and displayed until 21/11/2014
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 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   30-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to Section 4.4 - Special warnings and precautions for use
Change to Section 4.8 - Undesirable effects

                                            Change to Section 5.1 - Pharmacodynamic properties

                                            Change to Section 6.5 - Nature and contents of container

Updated on 20/09/2013 and displayed until 11/07/2014
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Aug-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Update to section 4.8 to encourage reporting of suspected adverse reactions by healthcare professionals and patients/consumers
Updated on 30/01/2013 and displayed until 20/09/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   17-Dec-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties

Updated on 02/10/2012 and displayed until 30/01/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   30-Aug-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties

 

Updated on 01/10/2012 and displayed until 02/10/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   30-Aug-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties

 

Updated on 10/04/2012 and displayed until 01/10/2012
Reasons for adding or updating:
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   23-Feb-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to Section: 4.6, 4.7, 4.8, 4.9 and 5.1.
Detailed SPC change information: Updated with results of renewal changes.

 

Updated on 05/03/2012 and displayed until 10/04/2012
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   sitagliptin phosphate monohydrate