Komboglyze 2.5mg-1000mg Tablets
- Name:
Komboglyze 2.5mg-1000mg Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/03/20
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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 20 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 24 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)
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 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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 20 July 2017 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 12 July 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 4.3 - 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 7 July 2017 PIL
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 1 February 2017 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 3 January 2017 SmPC
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 PIL
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 5 August 2016 SmPC
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 3 August 2016 PIL
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 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 13 May 2016 PIL
Reasons for updating
- 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 - 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 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 1 September 2015 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 addition of constipation as an adverse drug reaction.
Section 10 revision date updated.
Updated on 26 August 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 June 2015 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 3 June 2015 PIL
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 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 updated date of revision
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 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 7 August 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 14 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 20 November 2013 PIL
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 5 March 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 4.3 - 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 4 March 2013 PIL
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 SmPC
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
Shelf-life extended from 30 to 36 months
Section 10
Revision Date updated to reflect section 6.3 change.
Updated on 2 January 2013 SmPC
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
Updated on 2 January 2013 PIL
Reasons for updating
- New PIL for new product