Patient Information Leaflet

Synjardy 5mg/850mg Film-Coated Tablets

Synjardy 5mg/1.000mg Film-Coated Tablets

Synjardy 12,5mg/850mg Film-Coated Tablets

Synjardy 12,5mg/1.000mg Film-Coated Tablets

empagliflozina/hidrocloruro de metformina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Synjardy and what it is used for

2. What you need to know before you start taking Synjardy

3. How to take Synjardy

4. Possible side effects

5. Storage of Synjardy

6. Contents of the pack and additional information

What is Synjardy

Synjardy contains two active ingredients: empagliflozina and metformina. Both belong to a group of medications called “oral antidiabetic drugs”. These medications are taken by mouth to treat type2 diabetes.

What is type2 diabetes?

Type2 diabetes is a disease that is caused by a combination of genetic and lifestyle factors. If you have type2 diabetes, your pancreas does not produce enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This leads to high levels of glucose in your blood, which can cause medical problems such as heart disease, kidney disease, blindness, and poor circulation in your extremities.

How Synjardy works

Empagliflozina belongs to a group of medications called sodium‑glucose cotransporter type2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in the kidneys. This causes the removal of sugar (glucose) from the blood in the urine. Metformina works differently to reduce glucose levels in the blood, primarily by blocking the production of glucose in the liver.

As a result, Synjardy reduces the amount of sugar present in the blood. This medication may help prevent heart disease.

What is Synjardy used for

• Synjardy is added to diet and exercise to treat type2 diabetes in adult and pediatric patients aged 10 years and older who cannot be controlled by adding metformina alone or metformina with other diabetes medications.

• Synjardy can also be combined with other diabetes medications. These may be oral medications or injected medications, such as insulin.

• Additionally, Synjardy can be used as an alternative to taking empagliflozina and metformina as separate tablets. To avoid overdose, do not continue taking the separate tablets of empagliflozina and metformina if you are taking this medication.

It is essential that you follow the diet and exercise plan that your doctor, pharmacist, or nurse has recommended.

Do not take Synjardy

• if you are allergic to empagliflozina, metformina, or any of the other components of this medication (listed in section 6);
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis.Ketoacidosis is a condition in which ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor on the breath;
• if you have had diabetic precoma;
• if you have severe kidney problems. Your doctor may limit your daily dose or ask you to take another medication (see also section 3, "How to take Synjardy");
• if you have a severe infection, such as a lung or bronchial infection, or a kidney infection. Severe infections can lead to kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions");
• if you have lost a large amount of body water (dehydration), for example, due to severe or prolonged diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions");
• if you are being treated for acute heart failure or have recently had a heart attack, have severe circulation problems (such as "shock"), or have difficulty breathing. This can lead to a lack of oxygen supply to tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions");
• if you have liver problems;
• if you drink large amounts of alcohol, either daily or occasionally (see section "Taking Synjardy with alcohol").

Warnings and precautions

Risk of lactic acidosis

Synjardy may cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Synjardy for a short period of time if you have a condition that may be associated with dehydration (significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor, pharmacist, or nurse before starting this medication and during treatment:

• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or unusual fatigue, unusual sweet odor on the breath, sweet or metallic taste in the mouth, or unusual odor in urine or sweat, contact a doctor or the nearest hospital immediately and stop taking this medication until you speak with your doctor. These symptoms may be a sign of "diabetic ketoacidosis", a rare but serious condition that can occur with diabetes due to an increase in ketone bodies in the urine or blood, detected by analysis. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need for insulin due to major surgery or severe illness;
• if you have "type 1 diabetes": this type of diabetes usually begins when you are young and your body does not produce any insulin. Do not take Synjardy if you have type 1 diabetes;
• if you may be at risk of dehydration, for example:

• if you have vomiting, diarrhea, or fever, or if you cannot eat or drink;
• if you are taking medications that increase urine production (diuretics) or reduce blood pressure;
• if you are 75 years of age or older;

The possible signs are listed in section 4 in the subsection "dehydration". Your doctor may tell you to stop taking Synjardy until you recover to avoid excessive loss of body fluids. Ask them for ways to prevent dehydration.

• if you have a severe kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Synjardy until you recover;
• if you need to undergo a contrast medium examination with iodine (such as an X-ray or a gammagraphy). More information is provided below in the subsection "Other medications and Synjardy".

Consult your doctor immediately if you present a combination of symptoms such as pain, tenderness, redness, or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. These symptoms may be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene should be treated immediately.

Surgery

If you need to undergo major surgery, stop taking Synjardy while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Synjardy and when to resume it.

Kidney function

During treatment with Synjardy, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Care of the feet

As with all diabetic patients, it is essential to regularly monitor your feet and follow any other foot care advice provided by your healthcare professional.

Blood glucose in urine

Due to how this medication works, your urine will test positive for glucose while taking this medication.

Children and adolescents

Synjardy can be used in children aged 10 years and older for the treatment of type 2 diabetes mellitus.

Due to limited data, caution is recommended when using the medication in children between 10 and 12 years of age.

No data are available for children under 10 years of age.

Other medications and Synjardy

If you need to receive an intravenous injection of a contrast medium containing iodine, such as during an X-ray or a gammagraphy, stop taking Synjardy before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Synjardy and when to resume it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Synjardy. It is especially important to mention the following:

• medications that increase urine production (diuretics), as Synjardy may increase the risk of excessive fluid loss. Your doctor may ask you to stop taking Synjardy. The possible signs of excessive fluid loss from your body are listed in section 4.
• other medications that lower blood glucose, such as insulin or a "sulfonilurea". Your doctor may decide to reduce the dose of these other medications to prevent low blood glucose (hypoglycemia).
• medications that may modify the levels of metformin in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• bronchodilators (beta-2 agonists), used to treat asthma.
• corticosteroids (administered orally, injected, or inhaled), used to treat inflammation in conditions such as asthma and arthritis.
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medications that contain alcohol (see section "Taking Synjardy with alcohol").
• contrast media containing iodine (medications used during an X-ray; see section 2, "Warnings and precautions").
• if you are taking lithium, as Synjardy may reduce the amount of lithium in your blood.

Taking Synjardy with alcohol

Avoid excessive alcohol consumption while taking Synjardy, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Synjardy if you are pregnant. The safety of this medication for the fetus is unknown.

Metformin passes into breast milk in small amounts. The safety of empagliflozina in breast milk is unknown. Do not take Synjardy if you are breastfeeding.

Driving and operating machines

The influence of Synjardy on the ability to drive and operate machines is small.

Taking this medication in combination with sulfonilureas or insulin may cause low blood glucose (hypoglycemia), which can cause symptoms such as shakiness, sweating, and changes in vision that may affect your ability to drive and operate machines. Do not drive or operate tools or machines if you feel dizzy while taking Synjardy.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

The dose of Synjardy varies depending on your condition and the doses of diabetes medications you are currently taking. Your doctor will adjust the dose as needed and will indicate exactly what concentration of the medication you should take.

The recommended dose is one tablet twice a day. Normally, your doctor will start treatment with Synjardy by prescribing the tablet concentration that provides the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozina (5 mg twice a day). If you are already taking the two medications separately, your doctor will start treatment with the Synjardy tablets that provide the same amount of both. If you have reduced renal function, your doctor may prescribe a lower dose or decide to use an alternative medication.

Taking this medication

• Swallow the tablet whole with water.
• Take the tablets with food to reduce the likelihood of stomach discomfort.
• Take the tablet twice a day orally.

Your doctor may prescribe Synjardy along with another diabetes medication. Remember to take all medications as indicated by your doctor to achieve the best results for your health. Your doctor may need to adjust your doses to control your blood glucose levels.

A suitable diet and exercise help your body use your blood glucose better. It is essential to follow the diet and exercise plan recommended by your doctor while taking Synjardy.

If you take more Synjardy than you should

If you take more Synjardy tablets than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are nonspecific, such as nausea, vomiting, stomach pain with muscle cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Other symptoms are reduced body temperature and heart rate.If this happens, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medication immediately and contact a doctor or the nearest hospital right away (see section 2). Bring the medication packaging with you.

If you forget to take Synjardy

If you forget a dose, take it as soon as you remember. If you do not remember until it is time to take the next dose, omit the missed dose and return to the usual schedule. Do not take a double dose of this medication.

If you interrupt treatment with Synjardy

Do not stop taking Synjardy without consulting your doctor first, unless you suspect you have diabetic ketoacidosis, lactic acidosis, or a condition that can be associated with dehydration (see section 2 "Warnings and precautions"). Your blood glucose levels may increase if you interrupt treatment with Synjardy.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Get in touch with your doctor or the nearest hospital immediately if you experience any of the following side effects:

Severe allergic reaction, which has been observed at a frequency of less than 1 in 100 people.

The possible signs of a severe allergic reaction may include:

• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing.

Lactic acidosis, which has been observed at a frequency of less than 1 in 10,000 people.

Synjardy may cause a rare but serious side effect called lactic acidosis (see section 2). If this happens to you, you should stop taking Synjardy and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Diabetic ketoacidosis, which has been observed at a frequency of less than 1 in 1,000 people.

These are the signs of diabetic ketoacidosis (see section 2):

• Increased levels of "ketone bodies" in your urine or blood.
• Rapid weight loss.
• Nausea or vomiting.
• Abdominal pain.
• Excessive thirst.
• Deep and rapid breathing.
• Confusion.
• Unusual drowsiness or fatigue.
• Sweet or metallic taste in your mouth, or a different odor in your urine or sweat.

This can occur regardless of your blood glucose level. Your doctor may decide to temporarily or permanently discontinue treatment with Synjardy.

Get in touch with your doctor as soon as possible if you experience the following side effects:

Hypoglycemia (low blood glucose), which has been observed at a frequency of more than 1 in 10 people.

If you take Synjardy with another medicine that can cause low blood glucose, such as a sulfonylurea or insulin, the risk of low blood glucose is higher. The signs of low blood glucose include:

• Trembling, sweating, feeling anxious or confused, or rapid heartbeat.
• Excessive hunger, headache.

Your doctor will tell you how to treat low blood glucose and what to do if you experience any of the above symptoms. If you have symptoms of low blood glucose, take glucose tablets, eat a high-glucose snack, or drink fruit juice. Measure your blood glucose if possible and rest.

Urinary tract infection, which has been observed at a frequency of up to 1 in 10 people.

The signs of a urinary tract infection are:

• Burning sensation while urinating.
• Cloudy urine.
• Pain in the pelvis or middle back (when the kidneys are infected).

The urgency to urinate or urinate more frequently may be due to the way Synjardy works, but it can also be a sign of a urinary tract infection. If you experience an increase in these symptoms, contact your doctor.

Dehydration, which has been observed at a frequency of less than 1 in 100 people.

The signs of dehydration are not specific, but may include:

• Unusual thirst.
• Dizziness or lightheadedness when standing up.
• Fainting or loss of consciousness.

Other side effects while taking Synjardy:

Very common

• Feeling unwell (nausea), vomiting.
• Diarrhea or abdominal pain.
• Loss of appetite.

Common

• Genital fungal infection (candidiasis).
• Urinating more frequently or needing to urinate more often.
• Itching (pruritus).
• Rash or redness of the skin that may cause itching and include blisters, fluid secretion, or vesicles.
• Changes in the taste of things.
• Thirst.
• Laboratory tests may show an increase in blood lipid levels (cholesterol).
• Constipation.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, inflamed and red tongue, tingling sensation, or pale or yellowish skin). Your doctor may request certain tests to identify the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Rare

• Cellulitis necroticans of the perineum or Fournier's gangrene, a severe infection of the soft tissues of the genitals or the area between the genitals and the anus.

Very rare

• Abnormalities in liver function tests, inflammation of the liver (hepatitis).
• Redness of the skin (erythema).
• Inflammation of the kidneys (tubulointerstitial nephritis).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe that the packaging is damaged or shows visible signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Synjardy

The active ingredients are empagliflozina and metformina.

Each Synjardy 5 mg/850 mg film-coated tablet contains 5 mg of empagliflozina and 850 mg of metformina hydrochloride.

Each Synjardy 5 mg/1,000 mg film-coated tablet contains 5 mg of empagliflozina and 1,000 mg of metformina hydrochloride.

Each Synjardy 12.5 mg/850 mg film-coated tablet contains 12.5 mg of empagliflozina and 850 mg of metformina hydrochloride.

Each Synjardy 12.5 mg/1,000 mg film-coated tablet contains 12.5 mg of empagliflozina and 1,000 mg of metformina hydrochloride.

The other components are:

• Core tablet: maize starch, copovidone, anhydrous colloidal silica, magnesium stearate.
• Film-coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.

Synjardy 5 mg/850 mg and Synjardy 5 mg/1,000 mg film-coated tablets also contain yellow iron oxide (E172). Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Synjardy 5 mg/850 mg film-coated tablets are white-yellowish, oval, biconvex tablets. They are engraved with the inscription “S5” and the Boehringer Ingelheim logo on one side and the inscription “850” on the other. The tablet measures 19.2 mm in length and 9.4 mm in width.

Synjardy 5 mg/1,000 mg film-coated tablets are yellowish-brown, oval, biconvex tablets. They are engraved with the inscription “S5” and the Boehringer Ingelheim logo on one side and the inscription “1,000” on the other. The tablet measures 21.1 mm in length and 9.7 mm in width.

Synjardy 12.5 mg/850 mg film-coated tablets are white-pink, oval, biconvex tablets. They are engraved with the inscription “S12” and the Boehringer Ingelheim logo on one side and the inscription “850” on the other. The tablet measures 19.2 mm in length and 9.4 mm in width.

Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish-purple, oval, biconvex tablets. They are engraved with the inscription “S12” and the Boehringer Ingelheim logo on one side and the inscription “1,000” on the other. The tablet measures 21.1 mm in length and 9.7 mm in width.

The tablets are available in PVC/PVDC/aluminium perforated unit dose blisters. The pack sizes are 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets and the multiple packs containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets.

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer responsible for batch release

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim Hellas Single Member S.A.

5th km Paiania – Markopoulo

Koropi Attiki, 19441

Greece

Patheon France

40 boulevard de Champaret

Bourgoin Jallieu, 38300

France

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.