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AstraZeneca

Kerendia
finerenone

Package leaflet: Information for the patient


Kerendia 10 mg film-coated tablets Kerendia 20 mg film-coated tablets finerenone


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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.


Blood tests

These tests check your potassium level and how your kidneys are working.

Using the results of your blood tests, your doctor decides whether you can start to take Kerendia. After 4 weeks of taking Kerendia, you will have more blood tests.

Your doctor may test your blood at other times, for example while you are taking certain medicines.


Children and adolescents

Do not give this medicine to children and adolescents under 18 years because it is not known yet whether it is safe and effective in this age group.


Other medicines and Kerendia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines you can take. Your doctor may need to test your blood to make sure.


You must not take medicines that belong to the group of ‘strong CYP3A4 inhibitors,’ while taking Kerendia (see section 2 “Do not take Kerendia…”).


Talk to your doctor or pharmacist if you are taking other medicines while taking Kerendia, especially


Kerendia with food and drink

Do not eat grapefruit or drink grapefruit juice as long as you take Kerendia.

If you do, you may get too much finerenone in your blood. You may have more side effects (possible side effects are listed in section 4).

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.


Pregnancy

You should not take this medicine during pregnancy unless your doctor states it is clearly necessary. There might be a risk to your unborn baby. Your doctor will discuss that with you.

You should use reliable birth control if you are able to become pregnant. Your doctor will explain to you what type of birth control you can use.


Breast-feeding

You should not breast-feed while taking this medicine. It may harm your baby.


Driving and using machines

Kerendia has no effect on your ability to drive or use machines.


Kerendia contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


Kerendia contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.


  1. How to take Kerendia


    Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


    How much you have to take

    The recommended and the maximum daily dose of this medicine is 1 tablet of 20 mg.


    • Always take 1 tablet once daily. Each tablet contains 10 mg or 20 mg finerenone.

    • The starting dose depends on how well your kidneys work. To check this your doctor will test your blood. The results help your doctor to decide, if you can start with 1 tablet of 20 mg or 10 mg once daily.

    • After 4 weeks your doctor will test your blood again. Your doctor will decide on the correct dose for you. This might be 1 tablet of 20 mg or 10 mg once daily.

    Your doctor may also tell you to interrupt or stop taking Kerendia.


    Your doctor may decide on changes in your treatment after testing your blood. See “Blood tests” in section 2 for more information.


    How to take this medicine

    Kerendia is taken by mouth. Take Kerendia at the same time every day. This makes it easier for you to remember.


    Swallow the tablet whole.

    • You can take it with a glass of water.

    • You can take it with or without food.

    • Do not take it with grapefruit juice or grapefruit. See “Kerendia with food and drink” in section 2 for more information.


      If you cannot swallow the tablet whole, you can crush it.

    • Mix it with water or soft foods, such as apple sauce.

    • Take it right away.


      If you take more Kerendia than you should

      Talk to your doctor or pharmacist if you think you have taken too much of this medicine.


      If you forget to take Kerendia

      If you forget to take your tablet at your regular time that day

      ►take the tablet as soon as you notice it that day.


      If you miss a day

      ►take the next tablet on the next day, at your regular time. Do not take 2 tablets to make up for a forgotten tablet.

      If you stop taking Kerendia

      Only stop taking Kerendia if your doctor has told you. Your doctor may decide this after testing your blood.


      If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


  2. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them.


    Side effects that your doctor may see in your blood test results very common (may affect more than 1 in 10 people)

    • high potassium level (hyperkalaemia)

      Possible signs of high potassium level in the blood may include weakness or tiredness, feeling sick (nausea), numbness in the hands and lips, muscle cramps, decreased pulse rate.


      common (may affect up to 1 in 10 people)

    • low sodium level (hyponatraemia)

      Possible signs of low sodium level in the blood may include feeling sick (nausea), tiredness, headache, confusion; muscle weakness, spasms or cramps.

    • decrease in how well the kidneys filter blood (glomerular filtration rate decreased).


      uncommon (may affect up to 1 in 100 people)

    • decrease in a protein (haemoglobin) that is found in your red blood cells.


      Other side effects

      common (may affect up to 1 in 10 people)

    • low blood pressure (hypotension)

      Possible signs of low blood pressure may include dizziness, lightheadedness, fainting.

    • itching (pruritus)


      Reporting of side effects

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      If you get any side effects, talk to your doctor or pharmacist. 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.


  3. How to store Kerendia


    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, bottle label and 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 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.


  4. Contents of the pack and other information What Kerendia contains

iron oxide red (E 172, in Kerendia 10 mg film-coated tablets only), iron oxide yellow (E 172, in Kerendia 20 mg film-coated tablets only).


What Kerendia looks like and contents of the pack

Kerendia 10 mg film-coated tablets (tablets) are pink and oval-oblong, 10 mm long and 5 mm wide, marked ‘10’ on one side and ‘FI’ on the other side.


Kerendia 20 mg film-coated tablets (tablets) are yellow and oval-oblong, 10 mm long and a 5 mm wide, marked ‘20’ on one side and ‘FI’ on the other side.


Kerendia is available in cartons containing

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen Germany


Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee 51368 Leverkusen Germany

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


België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

България

Байер България ЕООД Tел.: +359 02 4247280

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Deutschland

Bayer Vital GmbH

Tel: +49 (0)214-30 513 48

Eesti

Bayer OÜ

Tel: +372 655 8565

Ελλάδα

Bayer Ελλάς ΑΒΕΕ Τηλ: +30-210-61 87 500

España

Bayer Hispania S.L. Tel: +34-93-495 65 00

France

Bayer HealthCare

Tél (N° vert): +33-(0)800 87 54 54

Hrvatska

Bayer d.o.o.

Tel: +385-(0)1-6599 900

Ireland

Bayer Limited

Tel: +353 1 216 3300

Ísland

Icepharma hf.

Sími: +354 540 8000

Italia

Bayer S.p.A.

Tel: +39 02 397 8 1

Κύπρος

NOVAGEM Limited

Tηλ: +357 22 48 38 58

Latvija

SIA Bayer

Tel: +371 67 84 55 63

Lietuva

UAB Bayer

Tel. +37 05 23 36 868

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Magyarország Bayer Hungária KFT Tel:+36 14 87-41 00

Malta

Alfred Gera and Sons Ltd. Tel: +35 621 44 62 05

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Norge

Bayer AS

Tlf: +47 23 13 05 00

Österreich

Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0

Polska

Bayer Sp. z o.o.

Tel: +48 22 572 35 00

Portugal

Bayer Portugal, Lda. Tel: +351 21 416 42 00

România

SC Bayer SRL

Tel: +40 21 529 59 00

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Slovenská republika

Bayer spol. s r.o.

Tel. +421 2 59 21 31 11

Suomi/Finland

Bayer Oy

Puh/Tel: +358- 20 785 21

Sverige

Bayer AB

Tel: +46 (0) 8 580 223 00

United Kingdom (Northern Ireland)

Bayer AG

Tel: +44-(0)118 206 3000


This leaflet was last revised in

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