Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - jardiance

Document Subject

Generated Narrative: MedicinalProductDefinition mp3897ae464fed2d09fdccd118642cb036

identifier: http://ema.europa.eu/identifier/EU/1/14/930/010

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Jardiance 10 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

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type: Strength part

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3897ae464fed2d09fdccd118642cb036

identifier: http://ema.europa.eu/identifier/EU/1/14/930/010

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - jardiance

Attesters

What is in 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

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 adults 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 (another diabetes medicine).

Jardiance can also be used with other medicines for the treatment of diabetes. 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 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 diabetes 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 effectively. 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 attacking 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. 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 Contact a doctor or the nearest hospital straight away: Ketoacidosis

if you experience 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, 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 prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. 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 your 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:* if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink* if you are taking medicines that increase urine production [diuretics] or lower blood pressure* if you are 75 years old 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 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 immediately 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 life-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 below 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 medicines that increase urine production (diuretics). Your doctor may ask 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 your 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 advice 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 drive 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 (milk sugar). If you have been told by your doctor 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 sodium (23 mg) per tablet, that is to say essentially sodium free .

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, your 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 help you to 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 medicines as directed by your doctor to achieve the best results for your health. Appropriate diet 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 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 consulting your doctor. If you have type 2 diabetes mellitus, your 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or 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, tongue, 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 (hypoglycaemia), 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 sulphonylurea or insulin, your risk of getting low blood 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 can also be signs of urinary tract infection. If you note an increase in such symptoms, you should also contact your doctor. Dehydration, seen very commonly (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 consciousness 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.

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 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 packaging 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 longer use. These measures will help protect the environment.

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, croscarmellose 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 tablets are available in PVC/aluminium 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 GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany Boehringer Ingelheim Hellas Single Member S.A. 5th km Paiania Markopoulo Koropi Attiki, 19Greece Rottendorf Pharma GmbH Ostenfelder Strasse 51 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: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595 . -

: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Lilly Deutschland GmbH Tel. +49 (0) 6172 273 2Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 Lilly S.A. Tel: +34 91 663 50 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Lilly France SAS T l: +33 1 55 49 34 Lilly Portugal Produtos Farmac uticos, Lda Tel: +351 21 412 66 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 Eli Lilly and Company (Ireland) Limited Tel: +353 1 661 4 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 Eli Lilly Italia S.p.A. Tel: +39 05 5425
Boehringer Ingelheim A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Eli Lilly and Company (Ireland) Limited Tel: +353 1 661 4This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: