Kerendia

Package leaflet: Information for the patient

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

finerenone
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Kerendia is and what it is used for

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

2. What you should know before taking Kerendia

Do not take Kerendia

• if you are allergic to finerenone or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines belonging to the group of "strong CYP3A4 inhibitors", for example:
• itraconazole or ketoconazole (used to treat fungal infections),
• ritonavir, nelfinavir, or cobicistat (used to treat HIV infections),
• clarithromycin, telithromycin (used to treat bacterial infections),
• nefazodone (used 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 the blood
• have severe loss of kidney function or kidney failure
• have moderate or severe liver problems
• have mild, moderate, or severe heart failure. This occurs when the heart does not pump blood properly, failing to pump enough blood with each heartbeat.

Blood tests
These tests are used to check your potassium levels and assess how well your kidneys are working.
Your doctor will decide whether you can start treatment with Kerendia based on the results of these blood tests.
Four weeks after starting treatment with Kerendia, you will have further blood tests.
Your doctor may also carry out blood tests 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 of age, as it is currently unknown 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 advise you which medicines you can take. Your doctor may need to carry out new blood tests for safety reasons.
Do not take medicines belonging to the group of "strong CYP3A4 inhibitors" during treatment with Kerendia (see section 2 "Do not take Kerendia...").
Talk to your doctor or pharmacist if you are taking other medicines during treatment with Kerendia, especially:

• if you are taking, for example:
• amiloride or triamterene (used to remove excess fluid from the body through urine)
• eplerenone, esaxerenone, spironolactone, or canrenone (medicines similar to finerenone)
• trimethoprim or a combination of trimethoprim and sulfamethoxazole (used to treat bacterial infections)
• potassium supplements, including certain salt substitutes, or if you are taking other medicines that may increase potassium levels in the blood. These medicines could be dangerous for you.
• if you are taking, for example:
• erythromycin (used to treat bacterial infections)
• verapamil (used to treat high blood pressure, chest pain, and rapid heartbeat)
• fluvoxamine (used to treat depression and "obsessive-compulsive disorder")
• rifampicin (used to treat bacterial infections)
• carbamazepine, phenytoin, or phenobarbital (used to treat epilepsy)
• St. John’s wort ( Hypericum perforatum ) (a herbal remedy used to treat depression)
• efavirenz (used to treat HIV infections), or if you are taking other medicines belonging to the same groups listed above (some "CYP3A4 inhibitors" and "CYP3A4 inducers"). You may experience more side effects, or Kerendia may not have the intended effect.
• if you are taking other medicines that lower blood pressure. Your doctor may need to monitor your blood pressure.

Kerendia with food and drink
Do not eat grapefruit and do not drink grapefruit juice during the entire duration of treatment with Kerendia.
Otherwise, you may have excessive levels 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy, unless your doctor considers it absolutely necessary. There may be a risk to the fetus; your doctor will explain this to you.
If you are of childbearing age, use a reliable method of contraception. Your doctor will explain the different types of contraceptive methods you can use.

Breastfeeding
Do not breastfeed during treatment with this medicine, as it may be harmful to the infant.

Driving and using machines
Kerendia has no effect on the ability to drive or use machinery.

Kerendia contains lactose
If your doctor has diagnosed you with an intolerance to certain 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 exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

What dose to take
The recommended and 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 of finerenone.
• The starting dose depends on how well your kidneys are working. To determine this, your doctor will order blood tests. The test results will help your doctor decide whether to start treatment with 1 tablet of 20 mg or 10 mg once daily.
• After 4 weeks, your doctor will perform further blood tests and determine the correct dose, which may be 1 tablet of 20 mg or 10 mg once daily. Your doctor may also instruct you to stop or discontinue taking Kerendia.

Your doctor may decide to adjust your treatment following any blood tests. For more information, see “Blood tests” in section 2.

How to take this medicine
Kerendia is taken by mouth. Take Kerendia at the same time each day; this will help you remember to take your medicine.
Swallow the tablet whole.

• You may take the tablet with a glass of water.
• You may 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 drink” in section 2.

If you are unable to swallow the tablet whole, it may be crushed.

• Mix the crushed tablet with water or a soft, semi-liquid food such as apple puree.
• Take the mixture immediately.

If you take more Kerendia than you should
If you think you have taken too much of this medicine, contact your doctor or pharmacist immediately.

If you forget to take Kerendia
If you forget to take the tablet at your usual time
► take it as soon as you remember, on the same day.
If you skip a whole day
► take the tablet the next day at your usual time.
Do not take two tablets to make up for a missed dose.

If you stop taking Kerendia
Stop taking Kerendia only if your doctor has instructed you to do so.
Your doctor may decide to stop treatment after reviewing your blood test results.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Side effects your doctor may detect from blood test results

Very common (may affect more than 1 in 10 people)

• high levels of potassium (hyperkalaemia). Possible signs of high potassium levels in the blood may include: weakness or tiredness, feeling unwell (nausea), numbness in hands and lips, muscle cramps, slowing of the pulse.

Common (may affect up to 1 in 10 people)

• low levels of sodium (hyponatraemia). Possible signs of low sodium levels in the blood may include: feeling unwell (nausea), tiredness, headache, confusion; muscle weakness, spasms or cramps.
• reduced kidney function in filtering 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 may include: dizziness, lightheadedness, fainting.
• itching

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the blister, the label of the bottle, and the carton after Scad./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kerendia contains

• The active substance is finerenone.
• Each tablet of Kerendia 10 mg film-coated tablets contains 10 mg of finerenone.
• Each tablet of Kerendia 20 mg film-coated tablets contains 20 mg of finerenone.
• The other components are:
• Tablet core: microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium lauryl sulfate. For further information see “Kerendia contains lactose” and “Kerendia contains sodium” in section 2.
• Tablet coating: hypromellose 2910, titanium dioxide, talc, iron oxide red (E 172, only in Kerendia 10 mg film-coated tablets), iron oxide yellow (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 mg are pink, oval-shaped, 10 mm long and 5 mm wide, with “10” engraved on one side and “FI” on the other side.
The film-coated tablets (tablets) of Kerendia 20 mg are yellow, oval-shaped, 10 mm long and 5 mm wide, with “20” engraved on one side and “FI” on the other side.
Kerendia is available in packs 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, unit-dose divisible blister 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel. +37 05 23 36 868

България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359 02 4247280 Tél/Tel: +32-(0)2-535 63 11

Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel: +36 14 87-41 00

Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05

Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: 31-(0)23-799 1000

Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 23 13 05 00

Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30-210-61 87 500 Tel: +43-(0)1-711 46-0

España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel: +48 22 572 35 00

France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00

Hrvatska România
Bayer d.o.o. SC Bayer SRL
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00

Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (0)1 58 14 400

Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel. +421 2 59 21 31 11

Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 8 1 Puh/Tel: +358- 20 785 21

Κύπρος Sverige
NOVAGEM Limited Bayer AB
Tηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00

Latvija United Kingdom (Northern Ireland)
SIA Bayer Bayer AG
Tel: +371 67 84 55 63 Tel: +44-(0)118 206 3000

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.