Synjardy

empagliflozin / metformin

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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 used with diet and exercise to treat adults with type 2 diabetes. It contains the active substances empagliflozin and metformin. Synjardy is used:

  • in patients whose diabetes is not sufficiently controlled by metformin alone;
  • in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;
  • in 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 1,000 mg of metformin, and can only be obtained with a prescription.

The recommended dose of Synjardy is one tablet twice a day with meals, 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 a sulphonylurea (a medicine that increases the body’s production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).

For further information, see the package leaflet.

How does Synjardy work?

In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the blood or the body is unable to use insulin effectively. This leads to a high level of glucose in the blood. The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, 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). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in 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.

Metformin works mainly by reducing the production of glucose in the body and reducing its absorption from 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 reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. HbA1c gives an indication of how well the blood glucose is controlled.

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.

Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects. The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke). The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. On average, patients in the study were followed up for 3.1 years. In those receiving empagliflozin, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo. Among these, in patients who were also taking metformin (the other active substance in Synjardy), the three major cardiovascular events occurred in 9.9% (344 out of 3,459) of patients receiving empagliflozin and in 10.9% (189 out of 1,734) of patients receiving placebo.

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 and 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:

  • metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma (dangerous complications of diabetes);
  • severely reduced kidney function or conditions that could affect the kidneys such as dehydration, severe infection or a steep fall in blood pressure;
  • a condition that could reduce the supply of oxygen to body tissues (such as in patients with worsening heart failure, recent heart attack, breathing difficulty 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. Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease. Because of concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed-dose combination, the CHMP recommended restricting its use in these patients.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synjardy have been included in the summary of product characteristics and the package leaflet.

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 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public ES = español 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public CS = čeština 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public DA = dansk 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public DE = Deutsch 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public ET = eesti keel 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public EL = elliniká 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public EN = English 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public FR = français 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public IT = italiano 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public LV = latviešu valoda 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public LT = lietuvių kalba 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public HU = magyar 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public MT = Malti 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public NL = Nederlands 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public PL = polski 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public PT = português 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public RO = română 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public SK = slovenčina 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public SL = slovenščina 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public FI = suomi 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public SV = svenska 2015-06-12 2017-07-05
Synjardy : EPAR - Summary for the public HR = Hrvatski 2015-06-12 2017-07-05
Name Language First published Last updated
Synjardy : EPAR - Risk-management-plan summary (English only) 2015-06-12  

This EPAR was last updated on 07/09/2017 .

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

Revision11
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

19/07/2017  Synjardy -EMEA/H/C/003770 -PSUSA/10388/201610

Name Language First published Last updated
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07
Synjardy : EPAR - Product Information EN = English 2015-06-12 2017-09-07

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 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20
Synjardy : EPAR - All Authorised presentations EN = English 2015-06-12 2015-11-20

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 2015-11-20 2017-09-07
Synjardy-H-C-PSUSA-00010388-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation EN = English 2017-08-03  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Assessment Report - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20 EN = English 2017-07-05  
Synjardy-H-C-3770-II-0015 : EPAR - Assessment Report - Variation EN = English 2017-05-10  
CHMP post-authorisation summary of positive opinion for Synjardy EN = English 2017-01-27  
Synjardy-H-C-3770-A-31-1432 : EPAR - Assessment Report - Article 31 EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy : EPAR - Scientific Conclusion EN = English 2017-01-09  
Synjardy-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations EN = English 2016-07-20  
Synjardy-H-C-3770-A20-1419-0001 : EPAR - Assessment Report - Article 20 EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  
Synjardy : EPAR - Scientific Conclusion EN = English 2016-05-19  

Initial marketing-authorisation documents

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