JARDIANCE 25 mg Film-Coated Tablets

Зміст інструкції

1. Jardiance 10 mg film-coated tablets, 25 mg film-coated tablets
   1. What is Jardiance and what is it used for
   2. What you need to know before you take Jardiance
   3. How to take Jardiance
   4. Possible side effects
   5. How to store Jardiance
   6. Contents of the pack and other information

Jardiance 10 mg film-coated tablets, 25 mg film-coated tablets

empagliflozin

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

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Jardiance is and what it is used for
• 2. What you need to know before you take 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 is Jardiance and what is it used for

What is Jardiance
Jardiance contains the active ingredient empagliflozin.
Jardiance belongs to a group of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors.

What is Jardiance used for
Type 2 diabetes mellitus

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

Jardiance blocks the SGLT2 protein in the kidneys, causing the removal of sugar from the blood
(glucose) through the urine. In this way, Jardiance reduces 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 continue the diet and exercise program recommended by your doctor, pharmacist or nurse.

Heart failure

• Jardiance is used to treat heart failure in adult patients with symptoms due to reduced 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 disease that results from genes and lifestyle. If you have type 2 diabetes, your
pancreas does not produce enough insulin to control blood glucose levels, and
the body cannot use its insulin effectively. This results in high blood glucose levels, which can cause health problems such as heart or kidney disease, blindness, and circulation problems in the limbs.

What is heart failure?
Heart failure occurs when the heart is too weak or stiff and is unable to
function properly. This can lead to serious medical problems and the need for hospital care. The most common symptoms of heart failure are feeling short of breath,
feeling constantly tired or very tired, and swelling of the ankles.
Jardiance helps protect the heart from weakening and improves symptoms.

What is chronic kidney disease?
Chronic kidney disease is a long-lasting condition. It can be caused by other diseases, such as
diabetes and high blood pressure, or even by your own immune system, which attacks the kidneys. When you have
chronic kidney disease, the kidneys may gradually lose their ability to clean and filter the
blood as they should. This can lead to serious medical problems, such as swelling of the legs or
heart failure, or the need for hospital care.
Jardiance helps protect the kidneys from losing their function.

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
Seek immediate medical attention or go to the nearest hospital:
Ketoacidosis

• if you experience rapid weight loss, if you have nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual tiredness, breath with a fruity odour, a metallic or sweet taste in your mouth or a different odour of your sweat or urine, seek immediate medical attention or go to the nearest hospital. These symptoms may indicate the presence of “ketoacidosis”, a serious and potentially life-threatening problem that can occur when levels of “ketone bodies” increase in the blood or urine found in laboratory analyses. The risk of developing ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, a sudden reduction in the dose of insulin, or an increased need for insulin caused by major surgery or serious illness. If you suspect you have ketoacidosis, seek immediate medical attention or go to the nearest hospital and stop taking this medicine until your doctor has given you further advice.

Talk to your doctor, pharmacist or nurse before taking this medicine, and
during treatment:

• if you have “type 1 diabetes”. This type of diabetes usually develops in youth and means that your body does not produce insulin. You should not take Jardiance if you have type 1 diabetes.
• if you have serious kidney problems - your doctor may limit the dose to 10 mg once a day or ask you to take a different medicine (see also section 3, “How to take Jardiance”).
• if you have serious liver problems - your doctor may ask you to take a different medicine.
• if you may be at risk of dehydration, for example: if you have vomiting, diarrhoea or fever or if you are unable to eat or drink or if you are taking medicines that increase urine production (diuretics) or lower blood pressure or if you are 75 years of age or older. The possible signs are listed in section 4, under “dehydration”. Your doctor may ask you not to take Jardiance until the condition has resolved, to prevent loss of too much body fluid. Ask how to prevent dehydration.
• if you have a serious kidney or urinary tract infection, with fever. Your doctor may ask you not to take Jardiance until the infection has healed.

Immediately inform your doctor if you observe a set of symptoms such as pain, tenderness,
redness or swelling of the genitals or the area between the genitals and the anus, with fever or a feeling of
general malaise. These symptoms may 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 the
subcutaneous tissue. Fournier's gangrene must be treated immediately.
Foot care
As in all diabetic patients, it is important to check your feet regularly and to follow any other advice
regarding foot care provided by healthcare professionals.
Kidney function
Your kidneys must be checked before starting and during treatment with this medicine.
Glucose in urine
Due to the mechanism of action of this medicine, your urine will test positive for sugar
while you are being treated with this medicine.

Children and adolescents
Jardiance can be used in children aged 10 years and over for the treatment of type 2 diabetes. There are 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, because 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 to inform your doctor:

• 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 are listed in section 4.
• if you are taking other medicines that lower blood sugar levels, for example insulin or a medicine containing “sulfonylurea”. Your doctor may lower the dose of these medicines to prevent blood sugar from dropping too low (hypoglycaemia).
• if you are taking lithium, because Jardiance may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Do not use
Jardiance if you are pregnant. It is not known whether Jardiance is harmful to the fetus. Do not use
Jardiance if you are breastfeeding. It is not known whether Jardiance passes into breast milk.

Driving and using machines
Jardiance slightly impairs the ability to drive and use machines.
Taking this medicine in combination with medicines called sulfonylureas and/or insulin
can lower blood sugar levels too much (hypoglycaemia), which can cause symptoms such as
tremor, sweating and altered vision, affecting the 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 (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take Jardiance

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

How much medicine 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 whether to increase the dose to 25 mg once a day, if necessary to help control blood sugar levels.
• Your doctor may limit the dose to 10 mg once a day if you have a kidney problem.
• Your doctor will prescribe the right dosage for you. Do not change the dose without your doctor telling you to do so.

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 the 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 in combination with another
antidiabetic medicine. Remember to take all medicines as prescribed by your doctor in order to
achieve the best results for your health.
An appropriate diet and exercise can help the body use blood sugar better. It is important to continue the diet and exercise program recommended
by your doctor while you are being treated with Jardiance.

If you take more Jardiance than you should
If you take more Jardiance than you should, consult your doctor immediately or go to the hospital straight away.
Bring the medicine packaging with you.

If you forget to take Jardiance
What to do if you forget to take a tablet (depends on how much time is left until the next
dose):

• If there are 12 hours or more until the next dose, take Jardiance as soon as you remember. Then take the next dose at the usual time.
• If there are less than 12 hours until the next dose, skip the dose you forgot. Then take the 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 consulting your doctor, unless you suspect
you have ketoacidosis (see “Ketoacidosis” under “Warnings and precautions”). If you have type 2
diabetes mellitus, blood sugar levels may increase when you stop treatment
with Jardiance.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

If you experience any of these symptoms, seek medical attention immediately or go to the nearest hospital.
Serious allergic reaction, observed uncommonly (may affect up to 1 in 100 people):
Possible signs of a serious allergic reaction may include:

• swelling of the face, lips, mouth, tongue or throat that may make it difficult to breathe or swallow

Diabetic ketoacidosis, observed uncommonly (may affect up to 1 in 100 people).
The signs of diabetic ketoacidosis are (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 fatigue
• breath with a sweetish smell, a metallic or sweetish taste in your mouth, or a different smell to your sweat or urine.

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

See your doctor as soon as possible if you notice the following side effects:
Low blood sugar (hypoglycemia), very common (may affect more than
1 in 10 people)
If you take Jardiance with another medicine that can cause low blood sugar
(hypoglycemia), such as a sulfonylurea or insulin, your risk of having low blood sugar is higher. Signs of low blood sugar may include:

• tremor, sweating, feeling of anxiety or confusion, racing heartbeat
• excessive hunger, headache

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

Urinary tract infection, common (may affect up to 1 in 10 people)
Signs of a urinary tract infection are:

• a burning sensation when passing urine
• urine that looks cloudy
• pain in your back, or pain in the side of your back (if the kidneys are infected)

A more frequent or urgent need to urinate may be due to how Jardiance works;
however, it can also indicate a urinary tract infection. If you notice an increase in these symptoms, you should
see your doctor.

Dehydration, very common (may affect more than 1 in 10 people)
The signs of dehydration are not specific but may include:

• unusual thirst
• feeling dizzy or lightheaded when you stand up
• fainting or loss of consciousness

Other side effects of Jardiance:
Common

• genital yeast infection (candidiasis)
• increased amount of urine or more frequent need to urinate
• itching
• skin rash or redness of the skin that may be itchy and include bumps, oozing or blisters
• thirst
• blood tests may show an increase in blood fats (cholesterol)
• constipation

Uncommon

• urticaria (hives)
• effort or pain when emptying the bladder
• blood tests may show a decrease in kidney function (creatinine or urea)
• blood tests may show an increase in the number of red blood cells (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

• inflammation of the kidneys (tubulo-interstitial nephritis)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 after "EXP" and on the
pack after “Scad.”. The expiry date refers to the last day of that month.
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.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Jardiance contains

• The active substance is empagliflozin.
• Each tablet contains 10 mg or 25 mg of empagliflozin.
• The other ingredients are:
• tablet core: lactose monohydrate (see the end of paragraph 2 under “Jardiance contains lactose”), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose (see the end of paragraph 2 under “Jardiance contains sodium”), anhydrous colloidal silica, magnesium stearate
• tablet coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E172)

Description of the appearance of Jardiance and contents of the pack
Jardiance 10 mg film-coated tablets are round, biconvex tablets with beveled edges,
of light yellow color. “S10” is imprinted on one side and the Boehringer Ingelheim logo is imprinted on the other side.
The tablets have a diameter of 9.1 mm.
Jardiance 25 mg film-coated tablets are oval, biconvex tablets, of light yellow
color. “S25” is imprinted on one side and the Boehringer Ingelheim logo is imprinted on the other side. The
tablet is 11.1 mm long and 5.6 mm wide.
Jardiance tablets are supplied in perforated blister packs divisible for unit dose in PVC/aluminum. The
packs contain 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.
Not all pack sizes may be marketed in your country.

Marketing Authorisation 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 further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900
Lilly Deutschland GmbH
Tel. +49 (0) 6172 273 2222

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Τηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00
Lilly S.A.
Tel: +34 91 663 50 00

Polska
Boehringer Ingelheim Sp.zo.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: +351 21 412 66 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Eli Lilly and Company (Ireland) Limited
Tel: +353-(0) 1 661 4377

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Eli Lilly Italia S.p.A.
Tel: +39 055 42571

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Τηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Eli Lilly and Company (Ireland) Limited
Tel: +353-(0) 1 661 4377
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
AUTHORISATION/S TO PLACE THE MEDICINAL PRODUCT ON THE MARKET
Scientific conclusions
In light of the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for empagliflozin, empagliflozin / metformin, the PRAC’s scientific conclusions are as follows:

• In light of the available data on the risk of “necrotizing fasciitis of the perineum (Fournier’s gangrene)” emerging from the literature and from spontaneous reports of Fournier’s gangrene in the non-diabetic population, and in light of a plausible mechanism of action, the PRAC considers that there is sufficient evidence to justify a modification of the product information to indicate that this adverse reaction may occur independently of the indication. The PRAC concluded that the product information for medicines containing empagliflozin should be modified accordingly.
• In light of the available data on phimosis emerging from spontaneous reports, and in light of the plausible mechanism of action, the PRAC considers that there is sufficient evidence to justify a modification of the product information to highlight that genital infections can cause phimosis with consequent need for circumcision. The PRAC concluded that the product information for medicines containing empagliflozin should be modified accordingly.
• In light of the available data on increased hematocrit/polycythemia emerging from the literature and from spontaneous reports, and in light of a plausible mechanism of action, the PRAC considers that there is sufficient evidence to justify a modification of section 4.4 of the SmPC to include that patients with marked increases in hematocrit should be monitored and investigated for underlying hematological diseases. The PRAC concluded that the product information for medicines containing empagliflozin should be modified accordingly.
• In light of the available data on prolonged ketoacidosis and prolonged glucosuria emerging from the literature and from spontaneous reports, the PRAC considers that there is sufficient evidence to justify a modification of section 4.4 of the SmPC relating to the warning on ketoacidosis, to indicate that in some patients ketoacidosis may persist even after discontinuation of empagliflozin treatment. The PRAC concluded that the product information for medicines containing empagliflozin should be modified accordingly.

Having examined the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the related overall conclusions and with the justification for the recommendation.

Justification for the variation of the authorisation/s to place the medicinal product on the market
Based on the scientific conclusions on empagliflozin, empagliflozin / metformin, the CHMP considers that the benefit/risk ratio of the medicinal product/s containing empagliflozin, empagliflozin / metformin is unchanged, save for the proposed changes to the product information.
The CHMP recommends the variation of the authorisation/s to place the medicinal product on the market.