Komboglyze 2.5mg-1000mg Tablets * Pharmacy Only: Prescription
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 May 2023
File name
646b4f283868d.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
646b4abd98244.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
63d00b41d0fc6.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_1638534038.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_1638533652.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_1614188618.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_1584707268.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_1584706625.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_1535117635.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_1535044015.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
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 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
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
Updated on 02 January 2013
Reasons for updating
- New PIL for new product