Prescribing Information for the Patient

Jardiance 10Film-Coated Tablets

Jardiance 25Film-Coated Tablets

empagliflozina

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this prescribing information. See section4.

What is Jardiance

Jardiance contains the active ingredient empagliflozina.

Jardiance is a member of a group of medicines known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.

What is Jardiance used for

Type 2 diabetes

• Jardiance is used to treat type 2 diabetes in adults and children aged 10 years and older who cannot control their condition with diet and exercise alone.
• Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
• Jardiance can also be used with other diabetes medicines. These may be taken orally or administered via injection, such as insulin.

Jardiance works by blocking the SGLT2 protein in the kidneys. This causes the removal of sugar (glucose) from the blood in the urine. As a result, Jardiance reduces the amount of sugar in the blood.

This medicine may also help prevent heart disease in patients with type 2 diabetes.

It is essential to follow the diet and exercise plan recommended by your doctor, pharmacist, or nurse.

Heart failure

• Jardiance is used to treat heart failure in adult patients with symptoms due to altered heart function.

Chronic kidney disease

• Jardiance is used to treat chronic kidney disease in adult patients.

What is type 2 diabetes?

Type 2 diabetes is a condition that results from a combination of genetic and lifestyle factors. If you have type 2 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 serious health problems such as heart disease, kidney disease, blindness, and poor circulation in your limbs.

What is heart failure?

Heart failure occurs when the heart is too weak or stiff and cannot function properly. This can lead to serious health problems and may require hospital care. The most common symptoms of heart failure are shortness of breath (dyspnea), persistent fatigue or intense fatigue, and swelling of the ankles.

Jardiance helps protect your heart from increased weakness and improves symptoms.

What is chronic kidney disease?

Chronic kidney disease is a long-term condition. It may be caused by other diseases such as diabetes and high blood pressure or even by the patient's immune system attacking the kidneys. When you have chronic kidney disease, your kidneys may gradually lose their ability to clean and filter your blood properly. This can cause serious health problems such as swollen legs, heart failure, or the need for hospital care.

Jardiance helps protect your kidneys from losing their function.

Do not take Jardiance

-if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Seek medical attention immediately:

Cetoacidosis

• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or a different odor in urine or sweat, seek medical attention immediately. These symptoms may be a sign of “cetoacidosis”, a serious and sometimes life-threatening condition that can occur due to increased levels of “ketones” in your urine or blood, detected by analysis. The risk of developing cetoacidosis 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 suspect you have cetoacidosis, seek medical attention immediately and stop taking this medicine until you speak with your doctor.

Consult your doctor, pharmacist, or nurse before starting to take this medicine and during treatment:

• if you have “type 1 diabetes”. This type of diabetes typically begins when you are young and your body does not produce any insulin. Do not take Jardiance if you have type 1 diabetes.
• if you have severe kidney problems; your doctor may limit your dose to 10 mg once a day or advise you to take a different medicine (see also section 3, “How to take Jardiance”).

• if you have severe liver problems; your doctor may ask you to take another medicine.
• you may be at risk of dehydration, for example:

• if you have nausea, diarrhea, or fever, or if you are unable to eat or drink
• if you are taking medicines that increase urine production (diuretics) or reduce blood pressure
• if you are 75 years of age or older.

The possible signs are included in section 4 in the subsection “dehydration”. Your doctor may ask you to stop taking Jardiance until you recover to prevent excessive fluid loss. Ask how to prevent dehydration.

• if you have a severe kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Jardiance until you recover.

Seek medical attention immediately if you experience 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, even potentially life-threatening, condition called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene must be treated immediately.

Foot care

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

Renal function

Your kidney function should be checked before starting this medicine and during treatment with it.

Urine glucose

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

Children and adolescents

Jardiance can be used in children aged 10 years or older for the treatment of type 2 diabetes. There are no data available for children under 10 years of age.

Jardiance is not recommended for children and adolescents under 18 years of age for the treatment of heart failure or for the treatment of chronic kidney disease because it has not been studied in these patients.

Other medicines and Jardiance

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

It is essential to inform your doctor in the following cases:

• if you are taking medicines that increase urine production (diuretics). Your doctor may ask you to stop taking Jardiance. The possible signs of excessive fluid loss from the body are included in section 4.
• if you are taking other medicines that lower your blood glucose levels, such as insulin or a “sulfonilurea”. Your doctor may decide to reduce the dose of these other medicines to prevent your blood glucose levels from dropping too low (hypoglycemia).
• if you are taking lithium, as Jardiance may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use Jardiance if you are pregnant. It is unknown whether Jardiance is harmful to the fetus. Do not use Jardiance if you are breastfeeding. It is unknown whether Jardiance passes into breast milk.

Driving and operating machines

The influence of Jardiance on your ability to drive and operate machines is small.

Taking this medicine in combination with medicines called sulfonilureas or with insulin may cause your blood glucose levels to drop too low (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 use tools or machines if you feel dizzy while taking Jardiance.

Jardiance contains lactose

Jardiance contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Jardiance contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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 recommended dose of Jardiance is a 10 mg tablet once a day. If you have type 2 diabetes, your doctor will decide if your dose should be increased to 25 mg once a day, if necessary, to help control your blood sugar level.
• Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
• Your doctor will prescribe the appropriate dose for you. Do not change your dose unless your doctor tells you to.

How to take this medication

• Swallow the tablet whole with water
• You can take the tablet with or without food
• You can take the tablet at any time of the day. However, try to take it at the same time every day. This will help you remember to take it.

If you have type 2 diabetes, your doctor may prescribe Jardiance along with another diabetes medication. Remember to take all your medications as instructed by your doctor to achieve the best results for your health.

A healthy 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 Jardiance.

If you take more Jardiance than you should

If you take more Jardiance than you should, consult a doctor immediately or go to the hospital. Bring the medication packaging with you.

If you forget to take Jardiance

If you forget to take a tablet, what to do depends on the time left until the next dose.

• If 12 hours or more are left until the next dose, take Jardiance as soon as you remember. Then, take the next dose at the usual time.
• If less than 12 hours are left until the next dose, skip the missed dose. Then, take the next dose at the usual time.
• Do not take a double dose of Jardiance to make up for the missed doses.

If you interrupt treatment with Jardiance

Do not interrupt treatment with Jardiance without consulting your doctor first, unless you suspect you have ketoacidosis (see "Ketoacidosis" in "Warnings and precautions"). If you have type 2 diabetes, your blood glucose levels may increase if you interrupt treatment with Jardiance.

If you have any other questions about using 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 a doctor or the nearest hospital immediately if you experience any of the following side effects:

Severe allergic reaction, observed infrequently (may affect up to 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

Cetoacidosis, observed infrequently (may affect up to 1 in 100 people)

These are the signs of cetoacidosis (see also section 2 "Warnings and precautions"):

• 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-smelling breath, sweet or metallic taste in the mouth, or unusual odor in urine or sweat

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

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

Low blood glucose (hypoglycemia), observed very frequently (may affect more than 1 in 10 people)

If you take Jardiance 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 extremely anxious or confused, or rapid heartbeat
• Excessive hunger, headache

Your doctor will instruct you on 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, observed frequently (may affect 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)

Increased urgency to urinate or urinating more frequently may be due to the way Jardiance works, but may also be signs of a urinary tract infection. If you experience an increase in these symptoms, get in touch with your doctor.

Dehydration, observed very frequently (may affect more than 1 in 10 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 Jardiance:

Frequent

• Genital fungal infections (candidiasis)
• Urinating more than usual or needing to urinate more frequently
• Itching
• Rash or skin redness that may cause itching and include bumps, fluid discharge, or blisters
• Thirst
• Increased levels of fats in the blood (cholesterol)
• Constipation

Infrequent

• Rashes
• Difficulty or pain when urinating
• Increased levels of fats in the blood (cholesterol)
• Decreased kidney function (creatinine or urea)
• Increased levels of red blood cells in the blood (hematocrit)

Rare

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

Very rare

• Tubulointerstitial nephritis, inflammation of the kidneys

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 thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on 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.

This medication does not require special conditions for conservation.

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

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

Composition of Jardiance

• The active ingredient is empagliflozina.
• Each tablet contains 10 mg or 25 mg of empagliflozina.

• The other components are:

• tablet core: lactose monohydrate (see end of section 2, in "Jardiance contains lactose"), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose (see end of section 2 in the section “Jardiance contains sodium”), anhydrous colloidal silica, magnesium stearate
• film coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E172)

Appearance of the product and contents of the pack

Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex, and have a beveled edge. They are engraved with the inscription "S10" on one side and the Boehringer Ingelheim logo on the other. The tablets measure 9.1 mm in diameter.

Jardiance 25 mg film-coated tablets are oval, pale yellow, and biconvex. They are engraved with the inscription "S25" on one side and the Boehringer Ingelheim logo on the other. The tablet measures 11.1 mm in length and 5.6 mm in width.

Jardiance tablets are available in perforated PVC/Al blisters. The pack sizes are 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 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

Responsible for manufacturing

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

Rottendorf Pharma GmbH

Ostenfelder Strasse 51 – 61

59320 Ennigerloh

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

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

Last update of the summary of product characteristics: {MM/AAAA}.

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