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Janumet 50 mg/1000 mg film-coated tablets

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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MSD Ireland (Human Health) Limited

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Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
Medicine Name Gardasil 9 suspension for injection in a pre-filled syringe Active Ingredients Human papillomavirus 9-valent vaccine
Medicine Name HALF SINEMET CR 25mg/100mg Prolonged-Release Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name HBVAXPRO 10mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name HBVAXPRO 40mcg Active Ingredients Hepatitis B vaccine (rDNA)
1 - 0 of 75 items.Total: Infinity pages

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

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)

Free text change information supplied by the pharmaceutical company

None provided

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