JARDIANCE 25 mg FILM-COATED TABLETS

2. What you need to know before you take Jardiance

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

Contact a doctor or the nearest hospital immediately:

Ketoacidosis

• if you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual fatigue, sweet breath odor, sweet or metallic taste in the mouth, or distinct odor in urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may be a sign of "ketoacidosis," a serious and potentially life-threatening problem that can occur due to an increase in "ketone bodies" in your urine or blood, detected by analysis. The risk of developing 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 suspect you have ketoacidosis, contact a doctor or the nearest hospital immediately and stop taking this medicine until you speak with your doctor.

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

• if you have "type 1 diabetes." This type of diabetes usually starts when you are young, and your body does not produce any 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 a day or may prescribe a different medicine (see also section 3, "How to take Jardiance").

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

Possible signs include those 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 severe kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Jardiance until you recover.

Consult your doctor immediately if you experience a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general malaise. These symptoms could be a sign of a rare but serious and 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.

Foot care

As with all diabetic patients, it is important that you 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

Due to the way 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. There is no data available in 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 for the treatment of chronic kidney disease, as it has not been studied in these patients.

Other medicines and Jardiance

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

It is important that you 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 from the body are included in section 4.
• if you are taking other medicines that lower the amount of glucose in your blood, 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 becoming 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Jardiance if you are pregnant. It is not known if Jardiance is harmful to the unborn baby. Do not use Jardiance if you are breastfeeding. It is not known if Jardiance passes into breast milk.

Driving and using machines

The ability to drive and use machines may be affected by Jardiance.

Taking this medicine in combination with medicines called sulfonylureas or with insulin may cause your blood glucose levels to become too low (hypoglycemia), which can cause symptoms such as shaking, sweating, and changes in vision that can affect your ability to drive and use 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 an intolerance to some sugars, contact your doctor 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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

What dose to take

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

How to take this medicine

• Swallow the tablet whole with water
• You can take the tablet with or without food
• You can take the tablet at any time of 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 mellitus, your doctor may prescribe Jardiance with another medicine for diabetes. Remember to take all your medicines as directed by your doctor to get the best results for your health.

A suitable diet and exercise will help your body make better use of the glucose in your blood. It is important to follow the diet and exercise plan recommended by your doctor, pharmacist, or nurse 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 the hospital. Take the medicine pack with you.

If you forget to take Jardiance

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

• If it is 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 it is 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 forgotten dose.

If you stop taking Jardiance

Do not stop taking 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 taking Jardiance.

If you have any further questions on 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 have any of the following side effects:

Severe allergic reaction, observed rarely (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 rarely (may affect up to 1 in 100 people)

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

• increase in "ketone bodies" in your urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness or unusual fatigue
• sweet breath odor, sweet or metallic taste in the mouth, or distinct odor in urine or sweat.

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

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

Low blood glucose levels (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 levels, such as a sulfonylurea or insulin, the risk of having low blood glucose levels is higher. Signs of low blood glucose levels include:

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

Your doctor will tell you how to treat low blood glucose levels and what to do if you have any of the above signs. If you have symptoms of low blood glucose levels, take glucose tablets, have a snack with a high glucose content, or drink a fruit juice.

Measure your blood glucose levels if possible and rest.

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

Signs of a urinary tract infection are:

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

The need to urinate urgently or frequently may be due to the way Jardiance 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, observed very frequently (may affect more than 1 in 10 people)

Signs of dehydration are not specific but may include:

• unusual thirst
• dizziness or fainting 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 (pruritus)
• rash or redness of the skin that may cause itching and include bumps, fluid-filled blisters, or crusts
• thirst
• blood tests may show an increase in the levels of fats in the blood (cholesterol)
• constipation

Uncommon

• hives
• straining or pain when urinating
• blood tests may show a decrease in kidney function (creatinine or urea)
• blood tests may show an increase in the amount of red blood cells in your blood (hematocrit)

Rare

• necrotizing fasciitis of the perineum or Fournier's gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus

Very rare

• kidney inflammation (tubulointerstitial nephritis)

Reporting of side effects

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

5. Storing Jardiance

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

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

This medicine does not require any special storage conditions.

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

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

6. Package Contents and Additional Information

Jardiance Composition

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

• The other ingredients 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 subsection “Jardiance contains sodium”), colloidal anhydrous silica, magnesium stearate
• film coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E172)

Product Appearance and Package Contents

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 single-dose perforated PVC/aluminum blisters. The package 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 package 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: {MM/AAAA}.

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