Synjardy - Empagliflozin and Metformin

What is Synjardy - Empagliflozin and Metformin and what is it used for?

Synjardy is an antidiabetic medicine indicated in adults to treat type 2 diabetes mellitus as an adjunct to diet and exercise to improve the control of blood glucose (sugar) levels. It contains two active substances, empagliflozin and metformin. Synjardy is indicated in the following groups:

  • in patients inadequately controlled on the maximum tolerated dose of metformin alone;
  • in patients inadequately controlled on metformin combined with other antidiabetic medicinal products, including insulin;
  • in patients who are already taking the combination of metformin and empagliflozin as separate tablets.

How are Synjardy - Empagliflozin and Metformin used?

Synjardy is available as tablets (5 or 12.5 mg of empagliflozin and 850 or 1 000 mg of metformin) and can only be obtained with a prescription. The recommended dose is one tablet twice a day. Therapy usually starts with a tablet providing the dose of metformin the patient is already taking, with the addition of the minimal dose (5 mg) of empagliflozin. Doses should be adjusted as needed.

When Synjardy is used in combination with insulin or with medicines that stimulate the body's production of insulin, a lower dose may be needed to reduce the risk of hypoglycaemia (low blood sugar). Treatment with this medicine is not recommended in some patients, including those aged 85 years or older or with moderate or severe renal impairment. For more information, see the package leaflet.

How does Synjardy - Empagliflozin and Metformin work?

Type 2 diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or in which the body cannot use insulin effectively, which leads to an increase blood glucose levels. The two active substances in Synjardy work differently to lower blood glucose and thus to control the symptoms of the disease. Empagliflozin works by blocking a protein found in the kidneys called the sodium-glucose cotransporter of type 2 (SGLT2), which normally reabsorbs glucose from the urine into the bloodstream. By blocking the action of this protein, empagliflozin induces the elimination of more glucose through the urine and, consequently, the reduction of blood glucose levels . Empagliflozin has been authorized in the EU under the trade name Jardiance since 2014. The active substance metformin works primarily by blocking the production of glucose in the liver and reducing its absorption in the intestine. Metformin has been available in the EU since the 1950s.

What benefit has Synjardy - Empagliflozin and Metformin shown during the studies?

The benefits of empagliflozin in combination with metformin have been demonstrated in 3 main studies involving 1,679 patients with type 2 diabetes and in which blood glucose levels were not adequately controlled by metformin, alone or in combination with others. antidiabetic medicines (including pioglitazone or a type of antidiabetic medicine called sulphonylurea). The studies compared the efficacy of empagliflozin and metformin with that of placebo (a dummy treatment) and metformin. The main measure of effectiveness was the change in the blood level of a substance called glycosylated hemoglobin (HbA1c), which provides an indication of how well the blood glucose is controlled after 24 weeks of treatment. Reduction in HbA1c in subjects treated with empagliflozin and metformin compared to the placebo and metformin group. Overall, there was a further decrease of 0.58% with a combination that provided a dose of 5 mg of empagliflozin twice daily and 0.62% with the 12.5 mg dose. In both cases, these were clinically relevant reductions. Similar benefits were seen in the studies regardless of the type of antidiabetic medicine used in the combination. Furthermore, the results indicate that the combination was associated with a beneficial reduction in body weight and blood pressure. Some other studies have provided further confirmation. Among these are the continuations of the main studies, which show that the benefits of the combination were maintained with continued therapy. Finally, the studies found that Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce hemoglobin HbA1c when added to insulin treatment.

What is the risk associated with Synjardy - Empagliflozin and Metformin?

The most common side effects of Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or with insulin, infections of the urinary tract or genitals, and increased urination. For the full list of side effects reported with Synjardy, see the package leaflet. Synjardy must not be used in patients:

  • with diabetic ketoacidosis or in diabetic pre-coma (severe complications of diabetes);
  • with moderate or severe renal impairment or rapidly changing conditions with potential for renal impairment such as dehydration, severe infection or shock;
  • have a condition that could lead to a reduced oxygen supply to the tissues (for example, heart or respiratory failure);
  • with liver impairment or alcoholism problems or alcohol intoxication. For the full list of restrictions, see the package leaflet.

Why has Synjardy - Empagliflozin and Metformin been 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 induce a clinically significant reduction in blood glucose in patients with type 2 diabetes and that its benefits and risks are consistent with those of the individual active substances. fixed dose combination, the CHMP recommended limiting the use of the medicine in these patients.

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

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 added to the summary of product characteristics and 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.

More information about Synjardy - Empagliflozin and Metformin

On 27 May 2015, the European Commission granted a "Marketing Authorization" for Synjardy, valid throughout the European Union. For more information on Synjardy therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 05-2015.

The information on Synjardy - Empagliflozin and Metformin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.

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