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Jardiance (empagliflozin) – Package leaflet - A10BK03

Updated on site: 08-Oct-2017

Medication nameJardiance
ATC CodeA10BK03
Substanceempagliflozin
ManufacturerBoehringer Ingelheim International GmbH

Package leaflet: Information for the patient

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

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 illness 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 section 4.

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

1.What Jardiance is and what it is used for

Jardiance contains the active substance empagliflozin which works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). SGLT2 prevents glucose from being excreted in urine by absorbing glucose into the bloodstream as blood is being filtered in the kidneys. By blocking this protein, the medicine causes glucose (blood sugar), sodium (salt) and water to be removed via the urine. Blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.

Jardiance is used to treat type 2 diabetes in adult patients (aged 18 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.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

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.

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

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

about what you can do to prevent dehydration

if you have “type 1 diabetes”. This type usually starts when you are young and your body does not produce any insulin.

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 “diabetic ketoacidosis” – a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing diabetic 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.

if you have serious kidney problems – your doctor may ask you to take a different medicine.

if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration. Possible signs are listed in section 4, ‘Possible side effects’ under ‘dehydration’.

if you are 85 years old or older as you should not start taking Jardiance.

if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid.

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.

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.

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 is not recommended for children and adolescents under 18 years, 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 a medicine used to remove water from the body (diuretic). Your doctor may ask you to stop taking Jardiance. Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects’.

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).

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.

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 starting dose of Jardiance is one 10 mg tablet once a day. Your doctor will decide whether to increase your dose to 25 mg once a day.

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.

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.

Diet and exercise can 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. 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.

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 straight away if you have any of the following side effects:

Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people)

These are the signs of diabetic 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 (hypoglycemia), 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 sulfonylurea 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 uncommonly (may affect up to 1 in 100 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 changes in blood fat (cholesterol) levels in your blood

Uncommon

hives

straining or pain when emptying the bladder

blood tests may show changes related to kidney function (creatinine or urea)

blood tests may show increases in the amount of red blood cells in your blood (haematocrit)

Not known

severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)

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 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.

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’), cellulose microcrystalline, hydroxypropylcellulose, croscarmellose 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 173

55216 Ingelheim am Rhein Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173

55216 Ingelheim am Rhein Germany

Boehringer Ingelheim Ellas A.E. 5th km Paiania – Markopoulo Koropi Attiki, 19400

Greece

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

SCS Boehringer Ingelheim Comm.V

Boehringer Ingelheim RCV GmbH & Co KG

Tél/Tel: +32 2 773 33 11

Lietuvos filialas

 

Tel: +370 37 473922

България

Luxembourg/Luxemburg

Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ -

SCS Boehringer Ingelheim Comm.V

клон България

Tél/Tel: +32 2 773 33 11

Тел: +359 2 958 79 98

 

Česká republika

Magyarország

Boehringer Ingelheim spol. s r.o.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +420 234 655 111

Magyarországi Fióktelepe

 

Tel: +36 1 299 89 00

Danmark

Malta

Boehringer Ingelheim Danmark A/S

Boehringer Ingelheim Ltd.

Tlf: +45 39 15 88 88

Tel: +44 1344 424 600

Deutschland

Nederland

Boehringer Ingelheim Pharma GmbH & Co. KG

Boehringer Ingelheim b.v.

Tel: +49 (0) 800 77 90 900

Tel: +31 (0) 800 22 55 889

Lilly Deutschland GmbH

 

Tel. +49 (0) 6172 273 2222

 

Eesti

Norge

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Norway KS

Eesti filiaal

Tlf: +47 66 76 13 00

Tel: +372 612 8000

 

Ελλάδα

Österreich

Boehringer Ingelheim Ellas A.E.

Boehringer Ingelheim RCV GmbH & Co KG

Tηλ: +30 2 10 89 06 300

España

Polska

Boehringer Ingelheim España, S.A.

Boehringer Ingelheim Sp. z o.o.

Tel: +34 93 404 51 00

Tel: +48 22 699 0 699

Lilly S.A.

 

Tel: +34 91 663 50 00

 

France

Portugal

Boehringer Ingelheim France S.A.S.

Boehringer Ingelheim, Unipessoal, Lda.

Tél: +33 3 26 50 45 33

Tel: +351 21 313 53 00

Lilly France SAS

Lilly Portugal Produtos Farmacêuticos, Lda

Tél: +33 1 55 49 34 34

Tel: +351 21 412 66 00

Hrvatska

România

Boehringer Ingelheim Zagreb d.o.o.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +385 1 2444 600

Viena - Sucursala Bucureşti

 

Tel: +40 21 302 28 00

Ireland

Slovenija

Boehringer Ingelheim Ireland Ltd.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +353 1 295 9620

Podružnica Ljubljana

 

Tel: +386 1 586 40 00

Eli Lilly and Company (Ireland) Limited

 

Tel: +353 1 661 4377

 

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Eli Lilly Italia S.p.A.

Tel: +39 05 5425 71

Κύπρος

Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle

Tel: +371 67 240 011

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

Eli Lilly and Company Limited

Tel: +44 1256 315 000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for empagliflozin, empagliflozin / metformin, the scientific conclusions of CHMP are as follows:

Hypersensitivity reactions have been noted in association with empagliflozin use in post-marketing experience. Cumulative review of post-marketing data up to 17 October 2016 revealed that a total of 320 cases with 362 hypersensitivity adverse drug reactions (ADRs) have been spontaneously reported for empagliflozin and 7 non-serious cases for empagliflozin+metformin. Of the 362 hypersensitivity ADRs for empagliflozin, in 92 times, time to onset was within 1 month and in 153 de-challenge was positive. In addition, there were 6 re-challenge cases and 3 of them were cases of rash.

Furthermore, an increase in angioedema ADRs was observed. Up to 17 October 2016, a total of 12 ADRs (1 serious) have been spontaneously reported according to the summary tabulation of ADRs from post-marketing data submitted by the Marketing Authorisation Holder (MAH). Of these 12 ADRs, 6 were received during the Periodic Safety Update Report (PSUR) reporting period.

The other medicinal products of the same class either list a range of hypersensitivity reactions in their Summary of Product Characteristics (SmPC) (canagliflozin) or this is currently under assessment (dapagliflozin).

During the assessment, the MAH presented a review of Standardised MedDRA query (SMQ) ‘Angioedema’ including a specific review on urticaria and angioedema. There has been urticaria events reported in clinical trials (37, 0.44%) as well as urticaria ADRs in post-marketing (61 up to 15 March 2017).

Overall, in view of the data presented in the reviewed PSUR, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is sufficient evidence to suspect a causal relationship between rash, angioedema and urticaria and empagliflozin treatment. Therefore, changes to the product information of medicinal products containing empagliflozin are warranted with consequential changes in the packaged leaflet.

On the other hand, cumulatively seven fatal cases of Diabetic Ketoacidosis (DKA) were presented by the Marketing Authorisation Holder. In line with other Sodium-glucose co-transporter 2 (SGLT2) inhibitors indicated in the treatment of type 2 diabetes, the PRAC considered it necessary to update the existing warning of diabetic ketoacidosis (DKA) on the occurrence of fatal cases.

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing empagliflozin were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for empagliflozin, empagliflozin / metformin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing empagliflozin, empagliflozin / metformin is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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