Onglyza 5 mg Film-Coated Tablets

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

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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.

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4.2 Posology and method of administration

Posology

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Special populations

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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.

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Editorial and administrative changes:

Sodium statement moved from SmPC section 2 to section 4.4

Removal of Northern Ireland adverse reporting details

Removal of Northern Ireland adverse reporting details

Removal of Northern Ireland adverse reporting details

Removal of Northern Ireland adverse reporting details

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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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This leaflet was last revised in 02/2021 11/2021

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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

12^th March 2020 26^th November 2021