Onglyza 2.5 mg Film-Coated Tablets

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Updated on 01 May 2024

File name

20240419 Package Leaflet IE MT Onglyza Film-Coated Tablets 2.5 mg T2DM Paediatric Indication CV 24 0011.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision

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2. What you need to know before you take Onglyza

Children and adolescents

Onglyza is not recommended for children and adolescents under 18 years. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Onglyza contains Ssodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.


6.Contents of the pack and other information

...

This leaflet was last revised in 04/2023 04/2024.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

CV 23 0014 CV 24 0011

Updated on 01 May 2024

File name

20240419 SPC IE MT Onglyza Film-Coated Tablets 2.5 mg 5 mg T2DM Paediatric Indication CV 24 0010.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

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4.2 Posology and method of administration

Posology

[…]

Special populations

[…]

Paediatric population

The safety and efficacy of Onglyza in children aged birth10 to < 18 years hasve not yet been established. Therefore, treatment of children and adolescents with saxagliptin is not recommended. No data are available. Currently available data are described in sections 5.1 and 5.2. Onglyza has not been studied in children under 10 years of age.


5.1 Pharmacodynamic properties

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Onglyza in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use). In a paediatric study, patients aged 10 to < 18 years old with inadequately controlled type 2 diabetes mellitus were randomised to saxagliptin (88 patients) or placebo (76 patients) as add-on to metformin, insulin or a combination of metformin and insulin. In this 26-week, placebo-controlled, double-blind randomised clinical study with a 26 week safety extension, patients received 2.5 mg saxagliptin (with potential dose-increase to 5 mg) or placebo once daily following a lead-in period. The primary efficacy endpoint was the change in HbA1c from baseline to 26 weeks of treatment. The treatment difference from placebo was not statistically significant [-0.44% (95% CI: -0.93, 0.05)]. The safety profile was similar to that observed in the adult population treated with saxagliptin.


5.2 Pharmacokinetic properties

Paediatric population

The pharmacokinetics of saxagliptin and its major metabolite in paediatric patients aged 10 to < 18 years with type 2 diabetes mellitus were similar to that observed in adults with type 2 diabetes mellitus.


10.Date of revision of the text

26th November 2021 19th April 2024

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

CV 23 0028 CV 24 0010


Editorial and administrative changes:

Sodium statement moved from SmPC section 2 to section 4.4

 

Updated on 19 September 2023

File name

20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

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Removal of Northern Ireland adverse reporting details.

Updated on 19 September 2023

File name

20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf

Reasons for updating

  • 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

Removal of Northern Ireland adverse reporting details.

Updated on 19 September 2023

File name

20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf

Reasons for updating

  • 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

Removal of Northern Ireland adverse reporting details.

Updated on 13 April 2023

File name

20230406 Package Leaflet IE MT Onglyza 2.5 mg Film-Coated Tablets Swedish Postcode Update CV 23 0014.pdf

Reasons for updating

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

Updated on 24 January 2023

File name

20211126 SPC IE MT Ongylza 2.5mg 5mg Film-Coated Tablets NI Details, BR Site CV 21 0041.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 Package Leaflet IE MT Onglyza 2.5mg Film-Coated Tablets NI Detail CV 21 0042.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

[..]

  1. 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

[..]

  1. 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 Ongylza 2.5mg 5mg Film-Coated Tablets NI Details, BR Site CV 21 0041.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)

 

Onglyza 2.5 mg film coated tablets

EU/1/09/545/011-015 14 film-coated tablets (calendar blister)

EU/1/09/545/012 28 film-coated tablets (calendar blister)

EU/1/09/545/013 98 film-coated tablets (calendar blister)

EU/1/09/545/014 30x1 (unit dose) film-coated tablets

EU/1/09/545/015 90x1 (unit dose) film-coated tablets

 

Onglyza 5 mg film coated tablets

EU/1/09/545/001-010 14 film-coated tablets

EU/1/09/545/002 28 film-coated tablets

EU/1/09/545/003 56 film-coated tablets

EU/1/09/545/004 98 film-coated tablets

EU/1/09/545/005 14 film-coated tablets (calendar blister)

EU/1/09/545/006 28 film-coated tablets (calendar blister)

EU/1/09/545/007 56 film-coated tablets (calendar blister)

EU/1/09/545/008 98 film-coated tablets (calendar blister)

EU/1/09/545/009 30x1 (unit dose) film-coated tablets

EU/1/09/545/010 90x1 (unit dose) 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 Onglyza Film-Coated Tablets 2.5mg BR Site Update CV 21 0010.pdf

Reasons for updating

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

Updated on 19 March 2020

File name

20200312 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0008.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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 March 2020

File name

20200312 Package Leaflet IE MT Ongylza 2.5 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0009.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 6 - date of revision

Updated on 24 August 2018

File name

2018-08-02 cPIL Onglyza 2_5 & 5mg Tablets UIM CV 18 0042.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 August 2018

File name

2018-08-02 cSPC Onglyza 2_5 & 5mg Tablets UIM CV 18 0041.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 Onglyza 2_5 & 5mg Tablets UIM CV 18 0041.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 6.5 - Nature and contents of container
  • 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 – Renal impairment dosing – no dose adjustment needed for GFR<45mL/min. Dose reduced to 2.5mg for patients with GFR<45mL/min.

Section 4.4 –In patients with GFR<45mL/min recommended dose is 2.5mg.

Section 4.8 – MHRA AE reporting updated

Section 5.2 – Study results for renal impairment patients updated

Sections 6.1, 6.5 & 8 – admin/editorial changes

Updated on 10 July 2018

File name

2018-06-28 cPIL Onglyza 2_5 & 5mg Tablets UIM CV 18 0042.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use

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 18 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 18 October 2017

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- UK Reporting details amended to be aligned with Appendix V of QRD template

Updated on 17 October 2017

File name

PIL_15016_811.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017

Reasons for updating

  • Change to section 4 - how to report a side effect

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 4.5 - 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 9 - Date of first authorisation/renewal of the authorisation
  • 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 text re-written to reflect new text in section 5.1.

Section 4.2 Minor editorial changes

Section 4.5 Minor editorial update.

Section 4.8 Minor editorial update including correction of spelling.

Section 5.1 information on ‘saxagliptin add on to dapagliflozin plus metformin therapy ‘added  and also information on ‘saxagliptin and dapagliflozin added on to metformin therapy’ added. Some text repositioned within this section.

Section 5.2 Minor editorial update.

Section 9 correction of date of first authorisation

Section 10- revision of date of update

Updated on 07 July 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 12 April 2017

Reasons for updating

  • Change to other sources of information section
  • Correction of spelling/typing errors

Updated on 16 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 12 May 2016

Reasons for updating

  • Change to side-effects
  • 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
  • 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 26 May 2015

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 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 – Add constipation as unknown frequency a side effect. Update MT ADR reporting address in line with QRD Template.

Section 10 – Update to revision date.

Updated on 21 May 2015

Reasons for updating

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

Updated on 30 March 2015

Reasons for updating

  • Change of manufacturer
  • Change to further information section
  • Change to date of revision
  • 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

Section7 MAH change
section 10 revision date

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 1 - Name of medicinal product
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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 1: data presented in line with QRD wording

- Section 4.2: Elderly populations and renal impairment wording updated in line with SAVOR study.

- Section 4.2: Method of administration section updated in line with Renewal changes.

- Section 4.4: Elderly populations, renal impairment, cardiac failure wording updated in line with SAVOR study.

- Section 4.5: Text reordered.

- Section 4.7: wording updated in line with QRD text during renewal.

- Section 4.8: Text updated in line with SAVOR study

- Section 4.8: AE reporting wording updated.

- Section 4.9: Overdose wording updated in line with Renewal changes.

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

Updated on 11 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 15 May 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • 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 Additon of ‘Diarrhoea’ in Table 2 and associated footnote
- Section 4.8 Amended IMB address details for AE reporting

- Seciton 10 Revision date

Updated on 08 May 2014

Reasons for updating

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

Updated on 08 August 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - 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)

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- Section 4.1 – addition of monotherapy indication

-Section 4.2 – change of wording ‘elderly’ to ‘older people’

- Section 4.8 – change from 10.2% to 10.1% under the sub-heading Hypoglycaemia

                     – addition of Adverse event reporting wording as per Appendix 5

- Section 5.1 – addition of the following text: (see Table 3). The findings of these studies were confirmed with two subsequent 24‑week regional (Asian) monotherapy studies comparing saxagliptin 5 mg with placebo.

-Section 5.2 – change of wording ‘elderly’ to ‘older people’

- Section 10 – updated date of revision

Updated on 05 August 2013

Reasons for updating

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

Updated on 20 June 2013

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 – information provided in ‘Post marketing experience from clinical trials and spontaneous reports’ under Table 2; addition of ‘Abdominal pain’ and frequency ‘Unknown’

- Section 10 – updated date of revision

Updated on 18 June 2013

Reasons for updating

  • Change to date of revision

Updated on 14 June 2013

Reasons for updating

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

Updated on 05 March 2013

Reasons for updating

  • 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
  • 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 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

- Section 2 – administrative changes to comply with EU template

- Section 4.1 – addition of Triple Oral Therapy indication

- Section 4.2 – modified to include advice not to split of cut tablets and also when using Onglyza in combination with insulin or sulphonylurea

- Section 4.3 – cross reference to section 6.1 included

- Section 4.5 – combined oral contraceptive included in list of products that Onglyza does not meaningfully alter the pharmacokinetics of

- 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 Onglyza 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 3

- Section 6.6 – minor update to comply with EU-template

- Section 10 – updated date of revision

 

Updated on 04 March 2013

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
  • Improved electronic presentation

Updated on 19 June 2012

Reasons for updating

  • Improved electronic presentation

Updated on 12 January 2012

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)

Free text change information supplied by the pharmaceutical company

Section 4.4

 

Additional Text

 

Pancreatitis

In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of saxagliptin. If pancreatitis is suspected, Onglyza and other potentially suspect medicinal products should be discontinued.

 

 

Section 4.8

 

Table 2           Frequency of additional adverse reactions by system organ class

 

Addition of:

 

Gastrointestinal disorders

Nausea                                    Common

Pancreatitis                             Uncommon

 

Dermatitis                                Uncommon

Pruritus                                    Uncommon

 

 

Section 10

 

Date of revision changed to 22nd December 2011

 

Updated on 11 January 2012

Reasons for updating

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

Updated on 02 December 2011

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

Section 4.1

 

New paragraph added

 

·         in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

 

 

Section 4.2

 

Addition of word insulin to first paragraph.

 

 

Section 4.4

 

General

 

New paragraph added.

 

 Onglyza is not a substitute for insulin in insulin‑requiring patients.

 

Hepatic impairment

 

Text amended to:

 

Use with medicinal products known to cause hypoglycaemia

Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.  

 

Section 4.8

 

New Paragraph added before “Investigations” paragraph

 

When used as add‑on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for Onglyza 5 mg and 19.9% for placebo.

 

Section 5.1

 

New paragraph added after paragraph 10

 

Saxagliptin add‑on combination therapy with insulin (with or without metformin)

A total of 455 patients with type 2 diabetes participated in a 24‑week randomised, double‑blind, placebo‑controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314). Saxagliptin 5 mg add‑on to insulin with or without metformin provided significant improvements after 24 weeks in HbA1c and PPG compared with placebo add‑on to insulin with or without metformin. Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add‑on to insulin regardless of metformin use (−0.4% for both subgroups). Improvements from baseline HbA1c were sustained in the saxagliptin add‑on to insulin group compared to the placebo add‑on to insulin group with or without metformin at Week 52. The HbA1c change for the saxagliptin group (n=244) compared to placebo (n=124) was ‑0.4% at Week 52.

 

Paragraph 12 Text amended to:

 

Patients with renal impairment

A 12 week, multi-centre, randomised, double-blind, placebo controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [n=90]; severe [n=41]; or ESRD [n=39]). In this study, 98.2% of the patients received other antihyperglycaemic treatments (75.3% on insulin and 31.2% on oral antihyperglycaemics; some received both). Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo). Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatments was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group). The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups. There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.

 

Table 3

 

Add-on Combination Studies updated.

 

New Paragraph at end of Section 5.1

 

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Onglyza in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).

 

 

Section 10

 

Date of revision changed to 22nd November 2011

 

European Medicines Agency website address updated.

 

Updated on 30 November 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 09 November 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.3

 Additional text.

 

or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase 4 (DPP4) inhibitor (see sections 4.4 and 4.8).

 

Section 4.4

 Addition of new text

 

During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema. If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes (see sections 4.3 and 4.8).

 

 

Section 4.8

New text and table (2)

 

Deletion of text under ‘Description of selected adverse reactions’.

 

In addition to the adverse reactions described above, adverse events reported regardless of causal relationship to the medicinal product and occurring more commonly in patients treated with Onglyza include hypersensitivity (0.6% vs. 0%) and rash (1.4% vs. 1.0%) as compared with placebo.

 

Section 10

Date of revision updated to 24th October 2011.

Updated on 08 November 2011

Reasons for updating

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

Updated on 14 June 2011

Reasons for updating

  • Addition of 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

None provided

Updated on 10 June 2011

Reasons for updating

  • New PIL for medicines.ie

Product Notice

Discontinued Strength Notice

Supply of Onglyza 2.5 mg Film-Coated Tablets to the Irish market will be discontinued by July 2024.