Janumet 50 mg/1000 mg film-coated tablets
- Name:
Janumet 50 mg/1000 mg film-coated tablets
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/11/20

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MSD Ireland (Human Health) Limited

Company Products
When a pharmaceutical company changes any document, 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 25 November 2020 PIL
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
WS/1898-Update Leaflet with respect to use in children and adolescents.
Updated on 25 November 2020 SPC
Reasons for 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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
WS/1898-Update SmPC sections 4.2, 4.8, 5.1 and 5.2 to include data from the pooled analysis of paediatric studies.
Updated on 26 June 2020 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2020 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 June 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To provide data on the sodium content per tablet in section 2.0 post approval of WS1803
Updated on 25 June 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC updated to include the results from WS1803, to provide data on the sodium content per tablet in section 4.4
Updated on 18 June 2019 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Converted the SPC from word document to pdf file format
Updated on 14 August 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 July 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The Marketing Authorisation holder has changed from Merck Sharp & Dohme Ltd UK to Merck Sharp & Dohme B.V. The Netherlands
Updated on 22 June 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 June 2018 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Thrombocytopenia is being added under the ‘Blood and lymphatic system’ disorders with a frequency ‘rare’.
Updated on 11 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 11 January 2018 SPC
Reasons for 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
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 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 10 January 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 10 August 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 August 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 January 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 5 January 2017 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 9 March 2016 SPC
Reasons for 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
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 8 March 2016 SPC
Reasons for 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
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
Change to Section 10 - Date of revision of the text
Reasons for submission: Type II, TECOS cardiovascular safety study (WS847)
Updated on 24 August 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 August 2015 SPC
Reasons for 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
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 (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 7 May 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
Updated on 10 April 2015 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 14 November 2014 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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 13 November 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 7 August 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Introduction of new pack/pack size
Updated on 14 July 2014 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
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 CONTAINERUpdated on 18 April 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
Updated on 15 April 2013 SPC
Reasons for 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
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 compositionChange 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 6 February 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 31 January 2013 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
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 25 October 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 10 October 2012 SPC
Reasons for 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
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 5 October 2012 SPC
Reasons for updating
- Addition of separate SPCs covering individual presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 5 July 2012 PIL
Reasons for updating
- Change to further information section
Updated on 17 November 2011 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 10 February 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 23 September 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 1 June 2010 PIL
Reasons for updating
- Change of manufacturer
- Change to further information section
Updated on 13 January 2010 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 7 October 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 30 September 2008 PIL
Reasons for updating
- New PIL for new product