KERENDIA 10 mg Film-Coated Tablets

Зміст інструкції

1. Kerendia 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Kerendia and what is it used for
   2. What you need to know before you take Kerendia
   3. How to take Kerendia
   4. Possible side effects
   5. How to store Kerendia
   6. Package contents and other information

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

finerenone

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before 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 or pharmacist.
• 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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Kerendia is and what it is used for
• 2. What you need to know before you take Kerendia
• 3. How to take Kerendia
• 4. Possible side effects
• 5. How to store Kerendia
• 6. Contents of the pack and other information

1. What is Kerendia and what is it used for

Kerendia contains the active ingredient finerenone, which works by blocking the action of certain hormones
(mineralocorticoids) that can damage the kidneys and the heart.
Kerendia is used for the treatment of adults with chronic kidney disease(with abnormal presence of the protein albumin in the urine) associated with type 2 diabetes.
Chronic kidney disease is a long-lasting condition. The kidneys gradually lose their
ability to remove waste and fluids from the blood.
Type 2 diabetes is a disease in which the body cannot maintain normal blood sugar levels. The body does not produce the hormone insulin or cannot use insulin
correctly. This leads to a high level of sugar in the blood.

2. What you need to know before you take Kerendia

Do not take Kerendia

• if you are allergicto finerenone or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines that belong to the group of “strong CYP3A4 inhibitors”, for example:
• itraconazoleor ketoconazole(to treat fungal infections),
• ritonavir, nelfinaviror cobicistat(to treat HIV infections),
• clarithromycin, telithromycin(to treat bacterial infections),
• nefazodone(to treat depression).
• if you have Addison's disease(a condition in which the body does not produce enough “cortisol” and “aldosterone” hormones).

Warnings and precautions
Talk to your doctor or pharmacist before taking Kerendia if you have

• ever been diagnosed with high levels of potassium in your blood
• severe loss of kidney function or kidney failure
• moderate or severe liver problems
• mild, moderate or severe heart failure. This happens when the heart does not pump blood as it should, does not pump enough blood with each heartbeat

Blood tests
These tests are used to check your potassium levelsand the degree of kidney function.
The doctor will decide if you can start treatment with Kerendia based on the results of the blood tests
.After 4 weeks of treatment with Kerendia you will undergo further blood tests.
The doctor may also perform blood tests on other occasions, for example while you are
taking certain medicines.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as it is
currently not known if use 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 medicine. The doctor will tell you which medicines you can take. The doctor may
need to perform new blood tests for safety.

Do not takemedicines that belong to the group of “strong CYP3A4 inhibitors” during the
treatment with Kerendia (see section 2 “Do not take Kerendia…”).

Talk to your doctoror pharmacist if you are takingother medicines during the treatment with
Kerendia, in particular

• if you take, for example
• amilorideor triamterene(to remove excess water from the body through urine)
• eplerenone, esaxerenone, spironolactoneor canrenone(medicines similar to finerenone)
• trimethoprimor a combination of trimethoprim and sulfamethoxazole(to treat bacterial infections)
• potassium supplements, including some salt substitutes or if you are taking other medicines that can increase potassium levels in the blood. These medicines could be dangerous for you.
• if you take, for example
• erythromycin(to treat bacterial infections)
• verapamil(to treat high blood pressure, chest pain and rapid heartbeat)
• fluvoxamine(to treat depression and “obsessive-compulsive syndrome”)
• rifampicin(to treat bacterial infections)
• carbamazepine, phenytoinor phenobarbital(to treat epilepsy)
• St John's Wort( Hypericum perforatum) (a herbal medicine to treat depression)
• efavirenz(to treat HIV infections) or if you are taking other medicines that belong to the same groups of medicines listed above (some “CYP3A4 inhibitors” and “CYP3A4 inducers”). You may experience more side effects or Kerendia may not have the expected effect.
• if you take other medicines that lower blood pressure. The doctor may need to check your blood pressure.

Kerendia with food and drink
Do not eat grapefruit and do not drink grapefruit juicethroughout the duration of treatment with
Kerendia.
Otherwise, you may have an excessive amount of finerenone in your blood and experience more
side effects(possible side effects are listed in section 4).

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.
Pregnancy

Do not takethis medicine during pregnancy unlessyour doctor considers it absolutely
necessary. There may be a risk to the fetus; the doctor will explain this to you.
If you are of childbearing potential, use a reliable method of contraception. The doctor will explain the different types of
contraceptive methods you can use.
Breastfeeding

Do not breastfeedduring treatment with this medicine, it may be harmful
to the baby.

Driving and using machines
Kerendia has no effects on the ability to drive and operate machines.

Kerendia contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

Kerendia 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 Kerendia

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

What dose to take
The recommended dose and the maximum daily doseof this medicine is 1 tabletof 20 mg.

• Always take 1 tablet once a day. Each tablet contains 10 mg or 20 mg of finerenone.
• The initial dosedepends on how your kidneys are functioning. To determine this, your doctor will prescribe blood tests. The results of the tests will help your doctor decide whether to start treatment with 1 tabletof 20 mgor10 mgonce a day.
• After 4 weeks, your doctor will perform new blood tests and establish the correct dose, which may be 1 tabletof 20 mg or 10 mgonce a day. Your doctor may also tell you to stop or discontinue taking Kerendia.

The doctor may decide to modify the treatmentafter any blood tests. For
more information see “Blood tests” in section 2.

How to take this medicine
Kerendia is taken orally. Take Kerendia every day at the same time; this will help you
remember to take the medicine.
Swallow the tablet whole.

• You can take the tablet with a glass of water.
• You can take the tablet with or without food.
• Do not take the tablet with grapefruit juice or grapefruit. For more information see “Kerendia with food and beverages” in section 2.

If you cannot swallow the tablet whole, it is possible to crush it.

• Mix the tablet with water or with semi-liquid food, such as applesauce.
• Take the tablet immediately.

If you take more Kerendia than you should
If you think you have taken an excessive dose of this medicine, contact your doctor or pharmacist.

If you forget to take Kerendia
If you forget to take the tablet at the usual time
►take the tablet as soon as you remember on the same day.
If you miss a day
►take the tablet the next day at the usual time.
Do not take two tablets to make up for forgetting the tablet.

If you stop taking Kerendia
Stop taking Kerendia only if your doctor has told you to do so.
The doctor may decide to stop the treatment after blood tests.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects that your doctor can recognise from blood tests
very common(may affect more than 1 in 10 people)

• high levels of potassium (hyperkalaemia) Possible signs of a high level of potassium in the blood can include: weakness or fatigue, feeling unwell (nausea), numbness of the hands and lips, muscle cramps, decreased pulse rate.

common(may affect up to 1 in 10 people)

• low levels of sodium (hyponatraemia) Possible signs of a low level of sodium in the blood can include: feeling unwell (nausea), fatigue, headache, confusion; muscle weakness, spasms or cramps.
• reduced ability of the kidneys to filter the blood (reduced glomerular filtration rate)
• high levels of uric acid (hyperuricaemia).

uncommon(may affect up to 1 in 100 people)

• decrease in a protein (haemoglobin) found in 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 can include: dizziness, lightheadedness, fainting.
• itching

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Kerendia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister, on the label of the bottle
and on the box after Scad./EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What Kerendia contains

• The active ingredient is finerenone.
• Each Kerendia 10 mg film-coated tabletcontains 10 mg of finerenone.
• Each Kerendia 20 mg film-coated tabletcontains 20 mg of finerenone.
• Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium lauryl sulfate. For more information see “Kerendia contains lactose” and “Kerendia contains sodium” in section 2.
• Tablet coating: hypromellose 2910, titanium dioxide, talc, red iron oxide (E 172, only in Kerendia 10 mg film-coated tablets), yellow iron oxide (E 172, only in Kerendia 20 mg film-coated tablets).

Description of the appearance of Kerendia and package contents
The film-coated tablets(tablets) of Kerendia 10 mgare pink in color, oval in shape
oblong, 10 mm long and 5 mm wide, with “10” imprinted on one side and “FI” on the other side.
The film-coated tablets(tablets) of Kerendia 20 mgare yellow in color, oval in shape
oblong, 10 mm long and 5 mm wide, with “20” imprinted on one side and “FI” on the other side.
Kerendia is available in boxes containing

• 14, 28 or 98 film-coated tablets. Each transparent calendar blister contains 14 film-coated tablets.
• 100 × 1 film-coated tablet. Each transparent perforated blister divisible for a single dose contains 10 film-coated tablets.
• 100 film-coated tablets in a plastic bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +37 05 23 36 868

България
Байер България ЕООД
Tел.: +359 02 4247280

Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

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

Danmark
Bayer A/S
Tlf: +45 45 23 50 00

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

Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48

Nederland
Bayer B.V.
Tel: 31-(0)23-799 1000

Eesti
Bayer OÜ
Tel: +372 655 8565

Norge
Bayer AS
Tlf: +47 23 13 05 00

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

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

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

Polska
Bayer Sp. z o.o.
Tel: +48 22 572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

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

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel: +40 21 529 59 00

Ireland
Bayer Limited
Tel: +353 1 216 3300

Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39 02 397 8 1

Suomi/Finland
Bayer Oy
Puh/Tel: +358- 20 785 21

Κύπρος
NOVAGEM Limited
Tηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .