Synjardy

empagliflozin / metformin

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Synjardy. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Synjardy.

For practical information about using Synjardy, patients should read the package leaflet or contact their doctor or pharmacist.

What is Synjardy and what is it used for?

Synjardy is a diabetes medicine that is used, in combination with diet and exercise, in adults with type 2 diabetes to improve the control of their blood glucose (sugar) levels. It contains two active substances, empagliflozin and metformin.

Synjardy is used in the following groups:

  • patients whose blood glucose levels are not satisfactorily controlled by the maximum tolerated dose of metformin alone;
  • patients taking metformin as an add-on to other diabetes medicines, including insulin, when combinations of these with metformin alone are insufficient;
  • patients who are already taking metformin and empagliflozin as separate tablets.
How is Synjardy used?

Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1000 mg of metformin, and can only be obtained with a prescription. The recommended dose is one tablet twice a day, and treatment is normally started with a tablet that supplies the dose of metformin the patient is already taking, together with the lowest dose (5 mg) of empagliflozin. Doses are adjusted as necessary.

If Synjardy is used in combination with insulin or medicines that make the body produce insulin, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels). Treatment with this medicine is not recommended in some patients, such as those aged above 85 years or with moderately or severely impaired kidney function. For further information, see the package leaflet.

How does Synjardy work?

Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood. The two active substances in Synjardy work in different ways to lower this, and thus to control symptoms of the disease.

Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2), which normally absorbs glucose back from the urine into the bloodstream. By blocking the action of this protein, empagliflozin causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood. Empagliflozin has been authorised in the EU under the trade name Jardiance since 2014.

The active substance metformin works mainly by blocking glucose production in the liver and reducing its absorption in the gut. Metformin has been available in the EU since the 1950s.

What benefits of Synjardy have been shown in studies?

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea). The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin. The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, after 24 weeks of treatment.

The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin. Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant. Similar benefits were seen in the studies regardless of the other diabetes medicines being taken. In addition, the results indicated that the combination was associated with a beneficial decrease in body weight and blood pressure.

Supportive evidence was provided from several further studies. Some of these were continuations of the main studies that suggested the benefits of the combination continued with longer therapy. Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.

What are the risks associated with Synjardy?

The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract or genitals, and increased urination. For the full list of all side effects reported with Synjardy, see the package leaflet.

Synjardy must not be used in patients with:

  • diabetic ketoacidosis or diabetic pre-coma (dangerous complications of diabetes);
  • moderately or severely reduced kidney function or with rapidly developing conditions that could affect the kidneys such as dehydration, severe infection or shock;
  • a condition that could lead to reduced supply of oxygen to body tissues (such as in patients who are being treated for worsening heart failure, have recently had a heart attack, have breathing problems or a steep fall in blood pressure);
  • liver impairment, or problems with alcoholism or alcohol intoxication.

For the full list of restrictions, see the package leaflet.

Why is Synjardy approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances. There were some concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed dose combination, and the CHMP recommended restricting its use in these patients.

What measures are being taken to ensure the safe and effective use of Synjardy?

A risk management plan has been developed to ensure that Synjardy is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Synjardy, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Synjardy

The European Commission granted a marketing authorisation valid throughout the European Union for Synjardy on 27 May 2015.

For more information about treatment with Synjardy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Synjardy : EPAR - Summary for the public BG = bălgarski 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public ES = español 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public CS = čeština 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public DA = dansk 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public DE = Deutsch 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public ET = eesti keel 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public EL = elliniká 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public EN = English 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public FR = français 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public IT = italiano 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public LV = latviešu valoda 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public LT = lietuvių kalba 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public HU = magyar 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public MT = Malti 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public NL = Nederlands 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public PL = polski 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public PT = português 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public RO = română 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public SK = slovenčina 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public SL = slovenščina 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public FI = suomi 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public SV = svenska 12/06/2015 16/06/2016
Synjardy : EPAR - Summary for the public HR = Hrvatski 12/06/2015 16/06/2016
Name Language First published Last updated
Synjardy : EPAR - Risk-management-plan summary (English only) 12/06/2015  

This EPAR was last updated on 20/07/2016 .

Authorisation details

Product details

Product details for Synjardy
NameSynjardy
Agency product numberEMEA/H/C/003770
Active substance

empagliflozin / metformin

International non-proprietary name (INN) or common name

empagliflozin / metformin

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD20
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Synjardy
Marketing-authorisation holder

Boehringer Ingelheim GmbH

Revision4
Date of issue of marketing authorisation valid throughout the European Union27/05/2015

Contact address:

Boehringer Ingelheim GmbH
Binger Strasse 173 
55216 Ingelheim am Rhein 
Germany

Product information

Product information

15/07/2016  Synjardy -EMEA/H/C/003770 -PSUSA/00010388/201510

Name Language First published Last updated
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016
Synjardy : EPAR - Product Information EN = English 12/06/2015 20/07/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015
Synjardy : EPAR - All Authorised presentations EN = English 12/06/2015 20/11/2015

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Synjardy is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients inadequately controlled on their maximally tolerated dose of metformin alone;
  • in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;
  • in patients already being treated with the combination of empagliflozin and metformin as separate tablets. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Synjardy : EPAR - Procedural steps taken and scientific information after authorisation EN = English 20/11/2015 20/07/2016
Synjardy-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations EN = English 20/07/2016  
Synjardy-H-C-3770-A20-1419-0001 : EPAR - Assessment Report - Article 20 EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  
Synjardy : EPAR - Scientific Conclusion EN = English 19/05/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Synjardy : EPAR - Public assessment report EN = English 12/06/2015  
CHMP summary of positive opinion for Synjardy EN = English 27/03/2015