Jardiance 25 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Jardiance 10 mg film-coated tablets

Jardiance 25 mg film-coated tablets

empagliflozin

Read all of this leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Jardiance is and what it is used for
2. What you need to know before taking Jardiance
3. How to take Jardiance
4. Possible side effects
5. How to store Jardiance
6. Contents of the pack and other information

1. What Jardiance is and what it is used for

What Jardiance is

Jardiance contains the active substance empagliflozin.

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

What Jardiance is used for

Type 2 diabetes mellitus

• Jardiance is used to treat type 2 diabetes in adults and children aged 10 years and older when blood sugar cannot be controlled by diet and exercise alone.
• Jardiance can be used without other diabetes medications in patients who cannot take metformin (another medicine used to treat diabetes).
• Jardiance can also be used together with other diabetes medicines. These may be medicines taken by mouth or given by injection, such as insulin.

Jardiance works by blocking the SGLT2 protein in your kidneys. This causes sugar (glucose) to be removed from the blood into the urine. In this way, Jardiance lowers the amount of sugar in the blood.

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

It is important that you 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 impaired 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 caused by your genes and lifestyle. 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 medical 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 too stiff to function properly. This can lead to serious medical problems and may require hospitalization. The most common symptoms of heart failure are shortness of breath (dyspnea), persistent or severe tiredness, and swelling of the ankles.

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

What is chronic kidney disease?

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

Jardiance helps protect your kidneys from losing their function.

2. What you need to know before taking Jardiance

Do not take Jardiance

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

Warnings and precautions

Contact a doctor or the nearest hospital immediately:

Ketoacidosis

• if you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, deep and rapid breathing, confusion, unusual drowsiness or tiredness, sweet-smelling breath, sweet or metallic taste in the mouth, or an unusual odour in your urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may be signs of “ketoacidosis”, a serious and sometimes potentially life-threatening condition that can occur due to increased levels of “ketone bodies” in your blood or urine, detected by laboratory tests. The risk of developing ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or serious illness.

If you suspect you have ketoacidosis, contact a doctor or the nearest hospital immediately and stop taking this medicine until you have spoken with your doctor.

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

• if you have “type 1 diabetes”. This type of diabetes usually starts at a young age and your body produces no insulin. You should 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 daily or recommend a different medicine (see also section 3, “How to take Jardiance”).

• if you have severe liver problems; your doctor may advise you to take a different medicine.

• if you may be at risk of dehydration, for example:

• if you have nausea, diarrhoea, or fever, or if you are unable to eat or drink,

• if you are taking medicines that increase urine production (diuretics) or lower blood pressure,

• if you are 75 years of age or older.

Possible signs are listed in section 4 under “dehydration”. Your doctor may ask you to stop taking Jardiance until you recover to prevent excessive fluid loss. Ask your doctor how to prevent dehydration.

• if you have a serious infection in the kidneys or urinary tract accompanied by fever. Your doctor may ask you to stop taking Jardiance until you recover.

Contact your doctor immediately if you develop a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, together with fever or general malaise. These symptoms could be signs of a rare but serious, even potentially life-threatening, infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys tissue under the skin. Fournier’s gangrene requires immediate treatment.

Foot care

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

Kidney function

Your kidney function should be checked before you start taking this medicine and during treatment with it.

Glucose in urine

Because of 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 and older for the treatment of type 2 diabetes. Data are not available for children under 10 years of age.

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

Other medicines and Jardiance

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

It is important 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. Possible signs of excessive fluid loss are listed in section 4.
• if you are taking other medicines that lower blood glucose levels, such as insulin or a “sulfonylurea”. Your doctor may decide to reduce the dose of these other medicines to prevent your blood glucose levels from dropping too low (hypoglycaemia).
• 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, think you may be pregnant, or are planning 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 unborn baby. Do not use Jardiance if you are breastfeeding. It is unknown whether Jardiance passes into breast milk.

Driving and using machines

The effect of Jardiance on the ability to drive and use machines is minor.

Taking this medicine in combination with medicines called sulfonylureas or with insulin may cause your blood glucose levels to drop too low (hypoglycaemia), which may cause symptoms such as trembling, sweating, and changes in vision that could affect your ability to drive and use machines. Do not drive or operate tools or machinery if you feel dizzy while taking Jardiance.

Jardiance contains lactose

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

Jardiance contains sodium

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

3. How to take Jardiance

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

• The recommended dose of Jardiance is one 10 mg tablet once daily. If you have type 2 diabetes mellitus, your doctor may decide to increase your dose to 25 mg once daily, if necessary, to help control your blood sugar level.
• Your doctor may limit your dose to 10 mg once daily if you have kidney problems.
• Your doctor will prescribe the appropriate dose for you. Do not change your dose unless instructed by your doctor.

Taking this medicine

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

If you have type 2 diabetes mellitus, your doctor may prescribe Jardiance together with another diabetes medicine. Remember to take all your medicines exactly as directed by your doctor to achieve the best results for your health.

A proper diet and exercise help your body use blood glucose more effectively. It is important 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, contact a doctor immediately or go to a hospital immediately. Take the medicine packaging with you.

If you forget to take Jardiance

If you forget to take a tablet, what you should do depends on how long it is until your next dose.

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

If you stop taking Jardiance

Do not stop treatment with Jardiance without first talking to your doctor, unless you suspect you have ketoacidosis (see “Ketoacidosis” in “Warnings and precautions”). If you have type 2 diabetes mellitus, your blood glucose levels may increase if you stop treatment with Jardiance.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact 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)

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

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

These are signs of ketoacidosis (see also section 2, “Warnings and precautions”):

• increased levels of “ketone bodies” in your urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness or tiredness
• sweet breath odour, sweet or metallic taste in the mouth, or unusual odour in urine or sweat

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

Contact your doctor as soon as possible if you experience the following side effects:

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

If you take Jardiance with another medicine that can cause low blood glucose, such as a sulphonylurea or insulin, the risk of low blood glucose is higher. Signs of low blood glucose include:

• trembling, sweating, feeling very anxious or confused, or rapid heartbeat
• excessive hunger, headache

Your doctor will advise you on how to treat low blood glucose and what to do if you experience any of the signs listed above. If you have symptoms of low blood glucose, take glucose tablets, eat a snack high in glucose, or drink fruit juice.

Check your blood glucose if possible, and rest.

Urinary tract infection, frequently observed (may affect up to 1 in 10 people)

Signs of a urinary tract infection include:

• burning sensation when urinating
• cloudy-looking urine
• pain in the pelvis or middle of the back (when the kidneys are infected)

The urge to urinate or urinating more frequently may be due to how Jardiance works, but they may also be signs of a urinary tract infection. If you experience an increase in these symptoms, contact your doctor.

Dehydration, very commonly observed (may affect more than 1 in 10 people)

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 normal or need to urinate more frequently
• itching (pruritus)
• rash or redness of the skin which may be itchy and may include bumps, oozing, or blisters
• thirst
• blood tests may show increased levels of blood fats (cholesterol)
• constipation

Uncommon

• hives
• difficulty or pain when emptying the bladder
• blood tests may show reduced kidney function (creatinine or urea)
• blood tests may show increased number of red blood cells in your blood (haematocrit)

Rare

• necrotising fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissue of the genitals or the area between the genitals and the anus

Very rare

• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, including any possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Jardiance

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

Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows any signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jardiance

• The active substance is empagliflozin.

• Each tablet contains 10 mg or 25 mg of empagliflozin.

• The other components are:

• tablet core: lactose monohydrate (see end of section 2 under “Jardiance contains lactose”), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose (see end of section 2 under “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 bevel-edged. They are marked 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 marked 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 unit-dose PVC/aluminum blister packs. Pack sizes are 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1, and 100 × 1 film-coated tablets.

Only some pack sizes may be marketed in your country.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

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 Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.