Trajenta 5 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Boehringer Ingelheim Limited
  • Status:

    No Recent Update
  • Legal 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 05 January 2022

File name

trajenta-pil-text-0047-G_1641379724.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 September 2021

File name

Trajenta PIL Text_1632841180.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

Free text change information supplied by the pharmaceutical company

 

 

Updated on 27 September 2021

File name

T4-EU-SPC-12 medicines.ie_1632755425.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

Title of the SmPC: now states United Kingdom (Northern Ireland), Republic of Ireland, Malta

AE reporting: reordered and now states United Kingdom (Northern Ireland)

Date of revision of the text

Updated on 11 June 2020

File name

EMEA-H-C-002110-N-0043-man site annex text_1591874280.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 January 2020

File name

EMEA-H-C-002110-N-0041 annex text_1579624699.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
  • Correction of spelling/typing errors

Updated on 16 December 2019

File name

Trajenta PIL_1576505637.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 16 December 2019

File name

T4-ALL-SPC-11-medicines.ie_1576499622.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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

PIL text - IB-0039_1565175440.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

T4-ALL-SPC-10_1565167162.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

The SmPC has been updated in section 4.8 and minor format changes in section 4.8, 5.1 to merge ADR frequency columns.  In addition, in section 4.8 of the SmPC AE reporting details for Ireland have been updated to align with Appendix V.   Date of revision has been updated

Updated on 07 May 2019

File name

002110-WS1461 Carmelina annex PIL text2_1557237960.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 02 May 2019

File name

T4-ALL-SPC-9_1556803594.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 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

SmPC has been updated in sections 4.4, 4.8, 5.1, 10 and minor format changes in section 4.4, 5.1

In addition in section 4.8 AE reporting details for the United Kingdom have been updated

Updated on 29 June 2018

File name

N-0032 annex text.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 01 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 01 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 13 June 2017

File name

PIL_15174_88.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 June 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 06 April 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

In section 4.4 a warning relating to bullous pemphigoid has been added

Updated on 06 April 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 22 February 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Improved presentation of PIL

Updated on 10 February 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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 4.1 the indication has been extended to include use in combination with other medicinal products for the treatment of diabetes.

In section 4.5 a minor editorial update has been made.

In section 4.8 side effects have been updated to include use in combination with metformin and empafliflozin. The side effect 'lipase increased' has also been added. Editorial updates have been made to AE reporting details to align with the European template.

In section 5.1 a statement on use of linagliptin as add-on to a combination of metformin and empagliflozin has been added, plus minor editorial correction.

Updated on 10 February 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 June 2016

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors
  • Change to side-effects

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 06 April 2016

Reasons for updating

  • Change of inactive ingredient
  • 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
  • Removal of black triangle

Updated on 05 April 2016

Reasons for updating

  • Removal 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 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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



-        Removal of the black triangle symbol and associated statement relating to additional monitoring.

-        Update to Section 4.8 to remove statements relating to the number of patients evaluated with Trajenta and number of people included in placebo-controlled studies.

The remaining updates are editorial revisions to sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 6.5 and 8.

Section 9, date of first authorization/renewal of the authorisation has been updated.

 

 

Updated on 04 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 5.2 - 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

Update to section 4.8 with addition of the side effect bullous pemphigoid with frequency not known. Minor editorial revisions have also been made to align with the annex text (section 4.2 and 5.2).

Section 10, date of revision of the text has been updated

Updated on 24 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 05 February 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 31 October 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use

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 27 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • 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 4.8 - 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

- Black triangle and additional monitoring/adr reporting statement have been included preceding SPC section 1.
- 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, 5.1 and 5.2

10. Date of revision
Updated to 08/2013

Updated on 10 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 6.5 - Nature and contents of container
  • 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 - side effects (addition of skin and subcutaneous tissue disorders plus other amendments)

Section 5.1 – pharmacodynamic properties (update to the sub-section on cardiovascular meta-analysis plus other amendments)

Sections 4.5, 5.2, 6.5 and 10 have also been updated – mainly editorial changes

Updated on 10 May 2013

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 23 November 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 19 November 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • 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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minor editorial change only

3. PHARMACEUTICAL FORM
Minor editorial change only

4.1 Therapeutic indications
Addition of a new indication under “as combination therapy”
• in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

4.2 Posology and method of administration
“or with insulin” and “or insulin” has been added to the 2nd sentence under Posology section:

When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4)

A few headings have been changed to include more detail.

Under “Elderly patients” the years of age has been increased and a caution added.

4.3 Contraindications
The sections being referred to have changed from 4.4 and 4.8 to “listed in section 6.1”.

4.4 Special warnings and precautions for use
The section under “Hypoglycaemia” has been amended to add insulin.

A new section on “Pancreatitis” has been added into section 4.4.

4.7 Effects on ability to drive and use machines
This section has been reworded and “insulin” has been added.

4.8 Undesirable effects
This section has been substantially updated.

5.1 Pharmacodynamic properties
New paragraphs have been added to this section including:

Linagliptin as add on to insulin therapy
The efficacy and safety of the addition of linagliptin 5 mg to insulin alone or in combination with metformin and/or pioglitazone has been evaluated in a double blind placebo controlled study of 24 weeks duration. Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%. Linagliptin also provided significant improvements in fasting plasma glucose (FPG), and a greater proportion of patients achieved a target HbA1c of < 7.0%, compared to placebo. This was achieved with a stable insulin dose (40.1 UI). Body weight did not differ significantly between the groups. Effects on plasma lipids were negligible. The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).



Linagliptin as add on therapy in elderly patients (age ≥ 70 years) with type 2 diabetes
The efficacy and safety of linagliptin in elderly (age ≥ 70years) type 2 diabetes patients was evaluated in a double blind study of 24 weeks duration. Patients received metformin and/or sulphonylurea and/or insulin as background therapy. Doses of background antidiabetic medications were kept stable during the first 12 weeks, after which adjustments were permitted. Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%. Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo. Body weight did not differ significantly between the groups.

The section “Cardiovascular risk” has been amended substantially.

5.2 Pharmacokinetic properties
The heading under “Special populations” called “Renal insufficiency” has been changed to “Renal impairment”

8. MARKETING AUTHORISATION NUMBER(S)
Details of pack sizes have been added to each Marketing Authorisation Number listed

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
“Date of first authorisation” has been added to the section.

10. DATE OF REVISION OF THE TEXT
Date has been updated to 10/2012

Updated on 12 April 2012

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 19 October 2011

Reasons for updating

  • New SPC for new product

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 19 October 2011

Reasons for updating

  • New PIL for new product