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Janumet film-coated tablets

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Pharmacy Only: Prescription

Updated on 25 August 2023

File name

QRD-IE-MT-UKNI-JANUMET-LFT-WS-2407-IB-0111-G-082023.pdf

Reasons for updating

  • Correction of spelling/typing errors
  • Change to further information section

Updated on 09 August 2023

File name

JANUMET-H-C-0861-WS-2407-IB-111-G-SPC-IE-en-CRT-01082023.pdf

Reasons for updating

  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • 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

Update to section 4.4 of the SmPC to include a warning for vitamin B12 deficiency.

Update to section 4.8 of the SmPC to change the frequency of vitamin B12 deficiency from very rare to common.

Update to the storage conditions in section 6.4 of the SmPC from “Do not store above 30 °C” to: “Do not store above 25 °C”

Editorial updates also made to sections 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 of the SmPC.

Update to the date of revision of the text in section 10. 

Updated on 09 August 2023

File name

QRD-IE-MT-UKNI-JANUMET-LFT-WS-2407-IB-0111-G-01082023.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to improve clarity and readability

Updated on 30 January 2023

File name

JANUMET-H-C-0861-WS-2091-SPC-IE-en-Sept 2021.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC document format updated to html.

Updated on 13 May 2022

File name

QRD-IE-MT-UKNI-JANUMET-LFT-BRX-NIP clean FT18Mar22.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.

Updated on 04 October 2021

File name

JANUMET-H-C-0861-WS-2091-SPC-IE-en-Sept 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Formatting changes only in sections 2.0, 3.0 and 8.0 and a new date of revision.

 

Updated on 04 October 2021

File name

QRD-IE-MT-JANUMET-LFT-WS-2091-CRT-16092021.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Individual PILs superseded by joint PIL.

 

Updated on 25 November 2020

File name

QRD-IE-MT-JANUMET-50-850MG tablets-LFT-WS-1898-Sept2020 (002).pdf

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

File name

JANUMET-H-C-0861-WS-1898-SPC-IE-en-CRT Sept2020 (002).pdf

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

File name

JANUMET-H-C-0861-WS-1803-SPC-IE-en-CRT-May2020 (002).pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 June 2020

File name

IE-MT-QRD-PIL-JANUMET-50-850MG-WS-1803-en-CRT (002).pdf

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

File name

JANUMET-H-C-0861-WS-1803-SPC-IE-en-CRT-May2020 (002).pdf

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

File name

JANUMET-H-C-0861-T-090-MAT Brexit-SPC-IE-en-CRT-June2018.pdf

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

File name

50-850-QRD-JANUMET-H-C-0861-T090-201807-PI-en-CRT-PIL (2).pdf

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

File name

JANUMET-H-C-0861-T-090-MAT Brexit-SPC-IE-en-CRT-June2018 (2).docx

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

File name

50-850 mg-QRD-JANUMET-H-C-0861-PSUSA-201708-PI-en-CRT-PIL (2).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 June 2018

File name

JANUMET-H-C-0861-PSUSA-2003-201708-SPC-IE-en-CRT-May2018 (2).docx

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

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

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

File name

PIL_13716_83.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 January 2018

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

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

Change to section 4.4: add Bullous pemphigoid as a warning

Updated on 10 August 2017

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

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 05 January 2017

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

Article 31 Referral

Updated on 09 March 2016

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 08 March 2016

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 4.2 - 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 24 August 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 August 2015

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

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 07 May 2015

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

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

To align the Janumet SmPC following the outcome of renewal procedure for Janumet duplicate product Ristfor (R-47)

Updated on 14 November 2014

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

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 31 July 2014

Reasons for updating

  • Introduction of new pack/pack size

Updated on 14 July 2014

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 CONTAINER

Updated on 18 April 2013

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

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 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 06 February 2013

Reasons for updating

  • Change to side-effects

Updated on 31 January 2013

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

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

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 05 October 2012

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

None provided

Updated on 05 July 2012

Reasons for updating

  • Change to further information section

Updated on 17 November 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 10 February 2011

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

Reasons for updating

  • Change to side-effects

Updated on 01 June 2010

Reasons for updating

  • Change of manufacturer
  • Change to further information section

Updated on 13 January 2010

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 07 October 2009

Reasons for updating

  • Change to side-effects

Updated on 19 December 2008

Reasons for updating

  • Change to appearance of the medicine

Updated on 30 September 2008

Reasons for updating

  • New PIL for new product