Janumet 50 mg/1000 mg film-coated tablets | Patient Info | MSD Ireland (Human Health) Limited

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Janumet 50 mg/1000 mg film-coated tablets

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Name:
Janumet 50 mg/1000 mg film-coated tablets
Company:
MSD Ireland (Human Health) Limited
Active Ingredients:
Metformin Hydrochloride, sitagliptin phosphate monohydrate
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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Summary of Product Characteristics last updated on medicines.ie: 25/11/2020

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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

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

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

Reasons for updating

Correction of spelling/typing errors

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

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 10 - Date of revision of the text

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

Reasons for updating

Improved presentation of SmPC

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

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

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 SmPC 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

Change to section 4.4: add Bullous pemphigoid as a warning

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

Article 31 Referral

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 4.2 - 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 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

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 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

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

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 CONTAINER

Updated 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 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 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)