Jentadueto 2.5 mg/850 mg film-coated tablets and Jentadueto 2.5 mg/1,000 mg film-coated tablets
*Company:
Boehringer Ingelheim LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 March 2024
File name
002279-0070-PIL Text.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 26 March 2024
File name
J1-EU-SPC-19.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
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The main changes to the SmPC are as follows:
- Section 4.2: Addition of a statement that use in children and adolescents is not recommended
- Section 4.8: Addition of a statement indicating that the safety profile of linagliptin in the paediatric population is similar to the safety profile in the adult population
- Section 5.1: Addition of clinical trial related information stating that no significant improvement on HbA1c levels was provided with use of linagliptin in the paediatric population
- Section 5.2: Addition of paediatric pharmacokinetic and pharmacodynamic information
- Section 10: Date of revision was updated.
Plus, multiple administrative updates are made throughout the SmPC to align with the current EU annex template.
Updated on 05 May 2023
File name
002279-WS2377-PIL Text.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 May 2023
File name
J1-EU-SPC-18.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 02 March 2023
File name
J1-EU-SPC-17 - med.ie.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 March 2022
File name
002279-IAIN-0064-G-PIL Text.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 September 2021
File name
Jentadueto PIL Text.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 27 September 2021
File name
J1-EU-SPC-17 - med.ie.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Title of the SmPC: now states United Kingdom (Northern Ireland), Republic of Ireland, Malta
Section 3: Correction of a punctuation mistake
AE reporting: reordered and now states United Kingdom (Northern Ireland)
Date of revision of the text
Updated on 28 April 2020
File name
EMEA-H-C-002279-IAIN annex text.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 23 April 2020
File name
J1-ALL-SPC-16-medicines.ie.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To include an additional pack size for each strength of the product
Section 6.5 has been updated to include details of the additional pack size
Section 8 has been updated to include the licence details for the additional packs
Section 10 has been updated to 14/04/2020
Updated on 21 January 2020
File name
EMEA-H-C-002279-N-0054 annex text.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
- Correction of spelling/typing errors
Updated on 16 December 2019
File name
J1-ALL-SPC-15-medicines.ie.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 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: Deletion of a statement regarding limited clinical experience of the use of this medicine in 80 year old and older patients
· Section 4.8: Editorial changes within the section “Other adverse reactions”
· Section 5.1: Addition of study data
· Section 10: Date of revision has been updated to 31 October 2019
Updated on 08 August 2019
File name
IB-0052-Annex PIL text.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 07 August 2019
File name
J1-ALL-SPC-14.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
- Section 4.8: to merge ADR frequency columns + Update to Irish AE reporting information in line with Appendix V.
- Section 5.1: Consequential administrative changes to section 4.8.
- Section 10: Date of revision has been updated.
Updated on 07 May 2019
File name
002279-WS1461 Carmelina annex PIL text.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 02 May 2019
File name
J1-ALL-SPC-13.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
SmPC has been updated in sections 4.4, 4.8, 5.1, 10 and minor format changes in section 4.4, 5.1
Updated on 30 July 2018
File name
Jentadueto 0044-anx text.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 27 July 2018
File name
J1-ALL-SPC-12.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 only changes to the SmPC are:
Section 4.8 - Administrate update to the AE reporting details for the UK - inclusion of the reference to the Google Play/ Apple App Store.
Section 10 - Date of revision of the text has been aligned with the date of Positive Opinion
Updated on 08 September 2017
File name
PIL_15504_650.pdf
Reasons for updating
- New PIL for new product
Updated on 08 September 2017
Reasons for updating
- Improved presentation of PIL
Updated on 02 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 August 2017
Reasons for updating
- 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
The changes are as follows:
-Sections 5.2: Details regarding the phase 2 PK/PD study in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus has been added in the Paediatric population sub-section.
-Section 10: date of revision of the text, has also been aligned with the date of Positive Opinion, which was 22/06/2017.Updated on 04 July 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 03 July 2017
Reasons for updating
- 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 10 May 2017
Reasons for updating
- Improved presentation of PIL
Updated on 07 April 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- 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
- Removal of black triangle
Updated on 06 April 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 4.6 - Pregnancy and lactation
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Removal of black triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4 a warning relating to bullous pemphigoid has been added
Sections 4.2, 4.3, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1 and 6.5 have been revised due to the renewal procedure. Changes include:
The black triangle has been removed
Section 4.8 has been restructured
Minor editorial updates to most sections; sections 4.3 and 6.1 contain very minor typorgaphical corrections
Section 9 contains the renewal date
Updated on 23 February 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Sections 4.1 (Therapeutic indications) and 5.1 (Pharmacodynamic properties) have been updated due to an Indication extension – Use of Jentadueto as add-on to a combination of metformin and empagliflozin
Section 4.4 (Special warnings and precautions for use) has been updated to remove the statement that Jentadueto should not be used for the treatment of diabetic ketoacidosis.
Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been updated to clarify ‘combination requiring precautions for use’
Section 4.8 (Undesirable effects) has been updated with addition of the side effect ‘lipase increased’
In addition minor editorial changes were made to sections 4.8, 5.1 and 5.2.
Updated on 21 February 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Improved presentation of PIL
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 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 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 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
In section 4.3 contraindications were updated to include any type of acute metabolic acidosis and severe renal failure. Contraindication in patients with renal dysfunction has been deleted.
In section 4.4 information on increased risk of lactic acidosis was added. The statement on renal function was revised to request GFR assessment prior to treatment and to temporarily discontinue treatment in conditions that alter renal function. Information on use of metformin and surgery was updated.
In section 5 statements on non-recommendation of concomitant use of alcohol and iodinated contract agents were revised. A statement on combinations requiring precautions for use was added.
Sections 4.8 and 5.1 were updated with minor editorial changes to table headings.
Section 10 was updated to include approval date
Updated on 31 May 2016
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
To revise the ADR frequencies in section 4.8 of the SPC. Section 10, date of revision of the text has also been updated.
Updated on 31 May 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 11 March 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 10 March 2016
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
Section 4.8 has been updated with addition of the side effect bullous pemphigoid with frequency not known. Section 10, date of revision of the text has also been updated.
Updated on 26 November 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- 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
Section 4.3 Contraindications – updated regarding disease which may cause tissue hypoxia (includes decompressed heart failure)
Section 4.4 Special warnings and precautions – Updated information on lactic acidosis - additional cautionary information relating to situations where renal function may become impaired; update to clarify when precaution should be taken and when the product is contraindicated in patients with reduced renal function and those with heart failure; update to information on use of iodinated contrast agent as this can lead to renal failure (consequential update to section 4.5)
In addition minor editorial corrections/updates have been made to sections 4.2, 4.4, 5.1 and 5.2.
Following a recent update of the European SPC template the two strengths of tablet have also been consolidated into one SPC. As a consequence sections 1, 2, 3, 6.1 and 8 have been revised.
Section 10, date of revision of the text has been updatedUpdated on 20 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to drug interactions
- Change to date of revision
- Change to MA holder contact details
- Addition of information on reporting a side effect.
Updated on 10 December 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 31 October 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 29 October 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
These variations concerned the submission of updated Product information and RMP following CHMP recommendation of Art.5(3) procedure on GLP-1 based therapies and pancreatic issues (EMA/671092/2013) - class labelling. This affects section 4.4 of the SPCs.
In addition the adverse reporting information for Ireland in section 4.8 have been updated to reflect the current required details.
10. Date of revision
Updated to 09/2014
Updated on 28 August 2014
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 19 February 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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
The following paragraph has been added to the section:
“Jentadueto is indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin and metformin alone do not provide adequate glycaemic control.”
4.2 Posology and method of administration
The following paragraph has been added to the section:
“For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
The dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When linagliptin plus metformin hydrochloride is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).”
4.4 Special warnings and precautions for use
This section has been updated as a consequence of the add-on to insulin
4.8 Undesirable effects
This section has been updated as a consequence of the add-on to insulin as well as other additional minor updates.
5.1 Pharmacodynamic properties
This section has been updated as a consequence of the add-on to insulin
10. Date of revision
Updated to 01/2014
Updated on 14 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to date of revision
Updated on 27 September 2013
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 16 September 2013
Reasons for updating
- Addition of black triangle
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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
- Section 4.8 – statement relating to the reporting of suspected adverse reactions has been added and agency contact points added
minor changes have been made to section 4.2, 4.4, 5.1 and 5.2 to change ‘elderly’ to ‘older’
The wording of the associated paragraphs has been amendment to accommodate this change as required.
10. Date of revision
Updated to 08/2013
Updated on 14 May 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 5.1 – pharmacodynamic properties (update to the sub-section on cardiovascular meta-analysis plus other amendments).
Sections 4.5, 5.2 and 10 have also been updated – mainly editorial changes.
Updated on 14 May 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 April 2013
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- 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 5.1 - a typographical error has been corrected in Table 4
Section 6.3 - to increase the shelf life of the product from 2 to 3 years
Section 10 – date of revision have been updated to 03/2013
Updated on 10 October 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- 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 04 October 2012
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 01 October 2012
Reasons for updating
- New PIL for new product
Updated on 28 September 2012
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)