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Komboglyze 2.5mg-1000mg Tablets

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Updated on 19 February 2024

File name

20240208 SPC IE MT Komboglyze 2.5 mg850 mg and 2.5 mg1000 mg Film-Coated Tablets Update Vit B12 Deficiency CV 24 0006.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 10 - Date of revision of the text

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

Updated on 19 February 2024

File name

20240208 Package Leaflet IE MT Komboglyze 2.5 mg1000 mg Film-Coated Tablets Update Vit B12 Deficiency CV 24 0005.pdf

Reasons for updating

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

Updated on 22 May 2023

File name

20230516 SPC IE MT Komboglyze 2.5 mg-850 mg and 2.5 mg-1000 mg Film-Coated Tablets Removal of NI details CV 23 0018.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Removal of Norther Ireland adverse reporting details

Updated on 22 May 2023

File name

20230516 Package Leaflet IE MT Komboglyze 2.5 mg-1000 mg Film-Coated Tablets Postcode update CV 23 0017.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

4.      Possible side effects

[...]

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

 

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

 

Malta

ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store


6.        Contents of the pack and other information

[...]

Marketing Authorisation Holder

 

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

 

Manufacturer

 

AstraZeneca AB

Gärtunavägen

SE-151 85152 57 Södertälje

Sweden

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

 

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

 

 

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

 

 

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

 

This leaflet was last revised in 11/202105/2023

Updated on 24 January 2023

File name

20211126 SPC IE MT Komboglyze 2.5mg-850mg and 2.5mg-1000mg NI Details, BR Site CV 21 0044.pdf

Reasons for updating

  • Document format updated

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

Updated on 03 December 2021

File name

20211126 PIL IE MT Komboglyze Film Coated Tablets 2.5-1000mg NI,BR site, CV210046.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 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Inserted text, Deleted text

[..]

4. Possible side effects

[..]

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.  This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[..]

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

[..]

6. Contents of the pack and other information

[..]

Manufacturer:

[..]

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

[..]

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

[..]

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

 

 

This leaflet was last revised in 02/2021 11/2021

 

Updated on 03 December 2021

File name

20211126 SPC IE MT Komboglyze 2.5mg-850mg and 2.5mg-1000mg NI Details, BR Site CV 21 0044.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Inserted text, Deleted text

[..]

4.8         Undesirable effects

[..]

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

[..]

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

[..]

8.            MARKETING AUTHORISATION NUMBER(S)

Komboglyze 2.5 mg/850 mg film‑coated tablets

EU/1/11/731/001 28 film‑coated tablets

EU/1/11/731/002 56 film‑coated tablets

EU/1/11/731/003 60 film‑coated tablets

EU/1/11/731/004 112 (2 packs of 56) film‑coated tablets

EU/1/11/731/005 196 (7 packs of 28) film‑coated tablets

EU/1/11/731/006 60x1 film‑coated tablets

EU/1/11/731/013 14 film‑coated tablets

 

Komboglyze 2.5 mg/1,000 mg film‑coated tablets

EU/1/11/731/007 28 film‑coated tablets

EU/1/11/731/008 56 film‑coated tablets

EU/1/11/731/009 60 film‑coated tablets

EU/1/11/731/010 112 (2 packs of 56) film‑coated tablets

EU/1/11/731/011 196 (7 packs of 28) film‑coated tablets

EU/1/11/731/012 60x1 film‑coated tablets

EU/1/11/731/014 14 film‑coated tablets

[..]

10.      DATE OF REVISION OF THE TEXT

12th March 2020 26th November 2021

Updated on 24 February 2021

File name

20210223 Package Leaflet IE MT Komboglyze Film-Coated Tablets 2.5mg-1000mg BR Site Update CV 21 0009.pdf

Reasons for updating

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

Updated on 20 March 2020

File name

20200312 SPC IE MT Komboglyze 2.5 mg-850 mg and 2.5 mg-1000 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0011.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 10 - Date of revision of the text

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

Updated on 20 March 2020

File name

20200312 Package Leaflet IE MT Komboglyze 2.5 mg-1000 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0013.pdf

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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 August 2018

File name

2018-08-13 cSPC Komboglyze 2.5-850mg & 2.5-1000mg Tabs UIM CV18 0039.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 23 August 2018

File name

2018-08-02 cSPC Komboglyze 2.5-850mg & 2.5-1000mg Tabs UIM CV180039.pdf

Reasons for updating

  • 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 10 was 28th June 2018 is now 2nd August 2018

Updated on 10 July 2018

File name

2018-06-28 cSPC Komboglyze 2.5-850mg & 2.5-1000mg Tablets UIM CV 18 0039.docx

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

Sections 2 & 3  -  admin/editorial changes

Section 4.2 – saxagliptin dosing for patients with GFR<30 is no longer contraindicated, now max daily dose of 2.5mg.

Section 4.4 – Moderate renal impairment now defined as GFR>30 to <45mL/min.

Section 4.8 – MHRA AE reporting updated

Section 5.2 – Study results for renal impairment patients updated

Sections 6.1 & 8 – admin/editorial changes

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 20 July 2017

File name

PIL_15590_864.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 July 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 12 July 2017

Reasons for updating

  • 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 4.5 - 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.1- indication re-written to incorporate updated information in section 5.1

Section 4.2  information on ‘For patients inadequately controlled on dual combination therapy of dapagliflozin and metformin, or for patients switching from triple combination therapy of saxagliptin, metformin and dapagliflozin taken as separate tablets’ added and editorial changes.

Section 4.3- editorial changes

Section 4.5 minor editorial changes

Section 4.8 minor editorial changes

Section 5.1 information on ‘ saxagliptin add on to dapagliflozin plus metformin therapy’ added and ‘saxagliptin and dapagliflozin add on to metformin therapy’ added.

Section 5.2 editorial changes

Section 5.3 editorial changes

Section 10 date of revision updated

Updated on 07 July 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 01 February 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 03 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 6.5 - Nature and contents of container
  • 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

4.2 inclusion of statement ‘ Adults with normal renal function (GFR  ≥ 90 mL/min) and update to information on renal impairment following article 31 on metformin containing products.

4.3 information on diabeteic ketoacidosis updated to include examples of other acute metabolic acidosis, information on renal impairment updated following article 31 on metformin containing products.

4.4 information on lactic acidosis and renal impairment updated and text on administration of iodinated contrast agents and surgery reworded following article 31 for metformin containing products,

4.5 Repositioning of text, text on alcohol and iodinated contrast agents re-worded. Information on medicinal products which affect renal function/lactic acidosis added following article 31 for metformin containing products and minor editorial changes.

4.6 Minor editorial changes

4.8 minor editorial changes

5.1 Minor editorial changes

5.2 Minor editorial changes

5.3 Minor editorial changes

6.5 minor editorial changes

7 minor editorial changes

10 revision date

Updated on 23 December 2016

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

Updated on 05 August 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - 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 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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



Section 2: Minor editorial amendments following renewal

Section 4.1: Minor editorial amendments  following renewal

Section 4.2 Minor editorial amendements following renewal. ‘Komboglyze’ changed to ‘medicinal product’ throughout the section and information on adolescents added to paediatric population

Section 4.3: Minor editorial amendments following renewal

Section 4.4: Removal of information on substitute for insulin, minor editorial amendments following renewal, Komboglyze changed to medicinal product throughout section.

Section 4.5 minor editorial amendments following renewal.

Section 4.6 minor editorial following renewal, Komboglyze changed to medicinal product throughout this section.

Section 4.7 Minor editorial following renewal

Section 4.8 Minor editorial following renewal

Section 5.1 Minor editorial following renewal

Section 5.2 Minor editorial following renewal

Section 5.3: minor editorial following renewal

Section 6.3 minor editorial-change from 36 months to 3 years

Section 6.6 removal of no special requirements

Section 9; minor editorial following renewal

Section 10: date of revision updated

Updated on 03 August 2016

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 18 May 2016

Reasons for updating

  • 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 5.1 Savor all cause mortality data included.

Section 10 Revision date updated.

Updated on 13 May 2016

Reasons for updating

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

Updated on 02 December 2015

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

Section 4.4 –updated text on cardiac failure warnings.

Section 4.4 – addition of arthalgia warning.

Section 4.8 – addition of footnote referring to section 4.4 for arthalgia side effect.

Section 10 – date of revision updated.

Updated on 01 December 2015

Reasons for updating

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

Updated on 01 September 2015

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 addition of constipation as an adverse drug reaction.

Section 10 revision date updated.

Updated on 26 August 2015

Reasons for updating

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

Updated on 08 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.8 Malta AE reporting wording updated (no change to date of revision)

Updated on 03 June 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer
  • Addition of information on reporting a side effect.

Updated on 28 October 2014

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

Section 7 MAH change
Section 10 updated date of revision

Updated on 24 October 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 13 August 2014

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 4.8 - 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 4.2: Elderly populations wording updated in line with SAVOR study.

- Section 4.4: Elderly populations wording updated in line with SAVOR study.

- Section 4.8: Text updated in line with SAVOR study

- Section 4.8: AE reporting wording updated.

- Section 5.1: updated in line with SAVOR study.
- Section 10: updated date of revision

Updated on 07 August 2014

Reasons for updating

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

Updated on 14 July 2014

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

- Section 4.4 Acute Pancreatitis text added
- Section 10 updated date of revision

Updated on 09 July 2014

Reasons for updating

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

Updated on 20 November 2013

Reasons for updating

  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 05 March 2013

Reasons for updating

  • 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 4.6 - 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 6.6 - Special precautions for disposal and other handling
  • 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 4.1 – addition of Triple Oral Therapy indication

- Section 4.2 – posology included for patients inadequately controlled on dual combination therapy of a sulphonylurea and metformin, or for patients switching from triple combination therapy of saxagliptin, metformin and a sulphonylurea taken as separate tablets.

- Section 4.3 – cross reference to section 6.1 included

- Section 4.4 – sulphonylurea added to sub-section regarding use with medicinal products known to cause hypoglycaemia

- Section 4.6 – typographical change

- Section 4.7 – advice included to warn patients of the risk of hypoglycaemia when used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas)

- Section 4.8 – information provided in description of selected adverse reactions when used as an add-on to metformin plus a sulphonylurea; additional information regarding hypoglycaemia

- Section 5.1 additional information regarding Onglyza add-on combination therapy with metformin and sulphonylurea; Additional study data included in Table 4

- Section 6.6 – addition of standard statement regarding disposal of unused product or waste material

- Section 10 – updated date of revision

Updated on 04 March 2013

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 date of revision
  • Improved electronic presentation

Updated on 15 January 2013

Reasons for updating

  • 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 6.3
Shelf-life extended from 30 to 36 months

Section 10
Revision Date updated to reflect section 6.3 change.

Updated on 02 January 2013

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 02 January 2013

Reasons for updating

  • New PIL for new product

Product Notice

Discontinued Strength Notice

Supply of Komboglyze 2.5 mg/1,000 mg film coated tablets to the Irish market will be discontinued by October 2024.