Jardiance – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Jardiance, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor , pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illne ss are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See secti on 4.
ℹ️ 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 co -transporter -2 (SGLT2) inhibitors.
What Jardiance is used for
Type 2 diabetes mellitus
- Jardiance is used to treat type 2 diabetes in adult s and children aged 10 years and older that cannot be controlled by diet and exercise alone .
- Jardiance can be used without other medicines in patients who cannot take metformin (an other diabetes medicine) .
- Jardiance can also be used with other medicines for the treatment of diabetes . These may be medicine s taken by mouth or given by injection such as insulin .
Jardiance works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Thereby Jardiance lowers the amount of sugar in your blood.
This medicine can also help prevent heart disease in patients with type 2 diab etes mellitus .
It is important that you continue with your diet and exercise plan as told 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 disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effective ly. This results in high levels of glucose in your blood which can lead to medical problems like 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 work properly . This can lead to serious medical problems and need for hospital care. The most common symptoms of heart failure are feeling breathless, feeling tired or very tired all the time, and ankle swelling.
Jardiance helps protect your heart from getting weaker and improves your symptoms.
What is chronic kidney disease?
Chronic kidney disease is a long -term condition. It might be caused by other diseases such as diabetes and high blood pressure or even by your own immune system att acking the kidneys. When you have chronic kidney disease, your kidneys may gradually lose their ability to clean and filter the blood properly. This can lead to serious medical problems such as swollen legs, heart failure or need for hospital care.
Jardi ance helps protect your 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
Contact a doctor or the nearest hospital straight away:
Ketoacidosis
- if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessiv e thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth , or a different odour to your urine or sweat , contact a doctor or the nearest hospital straight away . These symptoms could be a sign of “ketoacidosis”
- a serious, sometimes life -threatening problem you can get because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing ketoacidosis may be increased with prol onged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
If you suspect you have ketoacidosis, contact a doctor or the nearest hospital straight away and stop taking this medicine until further advice from your doctor.
Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
- if you have “type 1 diabetes”. This type usually starts when you are young and y our body does not produce any insulin. You should not take Jardiance if you have type 1 diabetes.
- if you have serious kidney problems – your doctor may limit your 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.
- might be at risk of dehydration , for example : o if you are being sick, have diarrhoea or fever, or if y ou are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure o if you are 75 years old or older .
Possible sign s are listed in section 4 under ‘dehydration ’. Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration.
- if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Jardiance until you have recovered.
Talk to your doctor immed iately if you develop 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 feeling generally unwell. These symptoms could be a sign of a rare but serious or even lif e-threatening infection, called necrotising fasciitis of the perineum or Fournier´s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.
Foot care Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine.
Urine glucose Because of how this medicine works, your urine will test positive for sugar 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. No data are available in children bel ow 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important to tell your doctor:
- if you are taking medicine s that increase urine production (diuretic s). Your doctor may as k you to stop taking Jardiance. Possible signs of losing too much fluid from your body are listed in section 4.
- if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent you r blood sugar levels from getting too low (hypoglycaemia) .
- if you are taking lithium because Jardiance can lower the amount of lithium in your blood .
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for ad vice before taking this medicine. Do not use Jardiance if you are pregnant. It is unknown if Jardiance is harmful to the unborn child. Do not use Jardiance if you are breast -feeding. It is not known if Jardiance passes into human breast milk.
Driving and using machines
Jardiance has minor influence on the ability to drive and use machines.
Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to d rive and use machines. Do not drive or use any tools or machines, if you feel dizzy while taking Jardiance .
Jardiance contains lactose
Jardiance contains lactose (mil k sugar). If you have been told by your doctor that you have an intolerance to some sugar s, contact your doctor before taking this medicine.
Jardiance contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.
💊 3. How to take Jardiance
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
- The recommended dose of Jardiance is one 10 mg tablet once a day . If you have type 2 diabetes mellitus, y our doctor will decide whether to increase your dose to 25 mg once a day , if needed to help to control your blood sugar .
- Your doctor may limit your dose to 10 mg once a day if you have a kidney problem .
- Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you to.
Taking 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 hel p you to remember to take it.
If you have type 2 diabetes mellitus, y our doctor may prescribe Jardiance together with another diabet es medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Approp riate d iet and exercise help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking Jardiance .
If you take more Jardiance than you should
If you take more Jardiance than you should, talk to a doctor immediately or go to a hospital immediately. Take the medicine pack with you.
If you forget to take Jardiance
What to do if you forget to take a tablet depends on how long it is until your next dose.
- If it is 12 hours o r 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 consulting your doctor , unless you suspect you have ketoacidosis (see “ketoacidosis” under “warnings and precau tions”). If you have type 2 diabetes mellitus, y our blood sugar levels may increase when 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 o r the nearest hospital straight away if you have any of the following side effects:
Severe allergic reaction, seen uncommonly (may affect up to 1 in 100 people) Possible signs of severe allergic reaction may include:
- swelling of the face, lips, mouth, tong ue, or throat that may lead to difficulty breathing or swallowing) Ketoacidosis, seen uncommonly (may affect up to 1 in 100 people) These are the signs of ketoacidosis (see also section 2 , ‘Warnings and precautions ’):
- increased levels of “ketone bodies” in your urine or blood
- rapid weight loss
- feeling sick or being sick
- stomach pain
- excessive thirst
- fast and deep breathing
- confusion
- unusual sleepiness or tiredness
- a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Jardiance .
Contact your doctor as soon as possible if you notice the following side effects:
Low blood sugar (hypoglyc aemia) , seen very commonly (may affect more than 1 in 10 people) If you take Jardiance with another medicine that can cause low blood sugar, such as a sul phonylurea or insulin, your risk of getting low bloo d sugar is higher. The signs of low blood sugar may include:
- shaking, sweating, feeling very anxious or confused, fast heart beat
- excessive hunger, headache Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.
Urinary tract infection , seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
- burning sensation when passing urine
- urine that appears cloudy
- pain in the pelvis, or mid -back pain (when kidneys are infected) An urge to pass urine or more frequent urination may be due to the way Jardiance works, but they c an also be signs of urinary tract infection . If you note an increase in such symptoms, you should also contact your doctor.
Dehydration , seen very common ly (may affect more than 1 in 10 people) The signs of dehydration are not specific, but may include:
- unusual thirst
- lightheadedness or dizziness upon standing
- fainting or loss of cons ciousness
Other side effects while taking Jardiance
Common
- genital yeast infection (thrush)
- passing more urine than usual or needing to pass urine more often
- itching
- rash or red skin – this may be itchy and include raised bumps, oozing fluid or blisters
- thirst
- blood tests may show an increase in blood fat (cholesterol) levels in your blood
- constipation
Uncommon
- hives
- straining or pain when emptying the bladder
- blood tests may show a decrease in kidney function (creatinine or urea)
- blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
Rare
- necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet . You can also report side effects directly via 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. How to store Jardiance
Keep this m edicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP ’.
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 packag ing is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longe r use. These measures wil l 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 empagliflozin.
- The other ingredients are :
- tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose’) , microcrystalline cellulose , hydroxypropylcellulose, croscarmello se sodium
(see end of section 2 under ‘Jardiance contains sodium’) , colloidal anhydrous silica, magnesium stearate
- film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
What Jardiance looks like and contents of the pack
Jardiance 10 mg film -coated tablets are round , pale yellow , biconvex and bevel -edged . They have “S10” on one side and the Boehringer Ingelheim logo on the other side. The tablets are 9.1 mm in diameter.
Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex . They have “S25” on one side and the Boehringer Ingelheim logo on the other side. The tablet is 11.1 mm long and has a width of 5.6 mm.
Jardiance table ts are available in PVC/alumin ium perforated unit dose 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 .
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Boehringer Ingelheim International G mbH 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 any information about this medicine, 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 Nederland Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889 Lilly Deutschland GmbH Tel. +49 (0) 6172 273 2222 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.
Tηλ: +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 Polska Boehringer Ingelheim Sp. z o.o.
Tel: +48 22 699 0 699 Lilly S.A.
Tel: +34 91 663 50 00 France Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33 Portugal Boehringer Ingelheim Portugal , Lda.
Tel: +351 21 313 53 00 Lilly France Tél: +33 -(0) 1 55 49 34 34 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 Bucure şti Tel: +40 21 302 28 00 Ireland Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 Eli Lilly and Company (Ireland) Limited Tel: +353 -(0) 1 661 4377 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 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800 Eli Lilly Italia S.p.A.
Tel: +39 05 5425 71 Κύπρος Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Tηλ: +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 This leaflet was last revised i n {MM/YYYY }.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Jardiance (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/930).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.