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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: 11/01/2018
SPC Janumet 50 mg/850 mg and 50 mg/1,000 mg 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 11/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   15-Dec-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



    Section 4.2:  The table of doses of metformin and sitagliptin to be taken in renal failure was revised

    Section 4.5: The section on drugs that interfere with the common renal tubular transport systems involved in the renal elimination of metformin has been expanded

                    Section 5.2: The description of the PK study results has been updated

Updated on 10/08/2017 and displayed until 11/01/2018
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 05/01/2017 and displayed until 10/08/2017
Reasons for adding or updating:
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Dec-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Article 31 Referral
Updated on 09/03/2016 and displayed until 05/01/2017
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



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
Reasons for submission: Type II, TECOS cardiovascular safety study (WS847)

Updated on 08/03/2016 and displayed until 09/03/2016
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 - Pharmacological 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

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
Reasons for submission: Type II, TECOS cardiovascular safety study (WS847)
Updated on 06/08/2015 and displayed until 08/03/2016
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Reasons for submission: Approval of WS742
Change to Section 4.8 - Undesirable effects (addition of ‘pruritus’, ‘bullous pemphigoid’ and ‘arthropathy’ to side-effects)
Change to Section 5.1 - Pharmacodynamic properties
Change to Section 5.2 - Pharmacokinetic properties
Change to Section 9 - Date of renewal of authorisation
Change to Section 10 - Date of revision of the text
Updated on 10/04/2015 and displayed until 06/08/2015
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:   17-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 Janumet SmPC following the outcome of renewal procedure for Janumet duplicate product Ristfor (R-47)
Updated on 14/11/2014 and displayed until 10/04/2015
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:   30-Sep-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



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

Updated on 14/07/2014 and displayed until 14/11/2014
Reasons for adding or updating:
  • 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 5.1 - PHARMACODYNAMIC PROPERTIES

                                                -CHANGE TO SECTION 6.5 - NATURE AND CONTENTS OF CONTAINER
Updated on 15/04/2013 and displayed until 14/07/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   29-Mar-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Editorial changes resulting from the Renewal application:

Change to Section 2 - Qualitative and quantitative composition
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 4.5 - Interactions with other medicinal products and other forms of interaction
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 5.2 - Pharmacokinetic properties
Change to Section 6.1 - List of excipients
Change to Section 6.3 - Shelf life
Change to Section 6.5 - Nature and contents of container
Change to Section 9 - Date of renewal of authorisation
Updated on 31/01/2013 and displayed until 15/04/2013
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:   18-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 10/10/2012 and displayed until 31/01/2013
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   05-Oct-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 - Pregnancy and lactation
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Change to Joint SPC covering all Presentations

Updated on 05/10/2012 and displayed until 10/10/2012
Reasons for adding or updating:
  • Addition of separate SPCs covering individual 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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