Onglyza 5 mg Film-Coated Tablets *
Pharmacy Only: Prescription

Updated on 24 January 2023

File name

63d00af8d03af.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 5mg Film-Coated Tablets NI Detail CV 21 0043_1638533335.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

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4. Possible side effects

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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.

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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

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6. Contents of the pack and other information

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Manufacturer:

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AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

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

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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_1638530912.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

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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:

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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

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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

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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 5mg BR Site Update CV 21 0011_1614188124.pdf

Reasons for updating

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

Updated on 19 March 2020

File name

20200312 Package Leaflet IE MT Ongylza 5 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0010_1584639607.pdf

Reasons for updating

  • New PIL for new product

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_1584639307.pdf

Reasons for updating

  • New SPC for new product

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