Onglyza 2.5 mg Film-Coated Tablets
- Name:
Onglyza 2.5 mg Film-Coated Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 19 March 2020 SmPC
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 August 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 23 August 2018 SmPC
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 SmPC
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 PIL
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2017 SmPC
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
Updated on 17 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 17 October 2017 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 12 July 2017 SmPC
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 7 July 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 12 April 2017 PIL
Reasons for updating
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 16 May 2016 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 2 December 2015 SmPC
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 1 December 2015 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 30 March 2015 PIL
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 SmPC
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 10 revision date
Updated on 24 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 13 August 2014 SmPC
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 7 August 2014 PIL
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 SmPC
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 9 July 2014 PIL
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 SmPC
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 8 May 2014 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 8 August 2013 SmPC
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)
Free text change information supplied by the pharmaceutical company
- 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 5 August 2013 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to date of revision
Updated on 14 June 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 5 March 2013 SmPC
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 4 March 2013 PIL
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 12 January 2012 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to warnings or special precautions for use
Updated on 2 December 2011 SmPC
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 PIL
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 9 November 2011 SmPC
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 8 November 2011 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 14 June 2011 SmPC
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
Updated on 10 June 2011 PIL
Reasons for updating
- New PIL for medicines.ie