KERENDIA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Kerendia 10 mg Film-Coated Tablets

Kerendia 20 mg Film-Coated Tablets

finerenone

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of Kerendia
6. Contents of the pack and other information

1. What is Kerendia and what is it used for

Kerendia contains the active substance finerenone. Finerenone works by blocking the action of certain hormones (mineralocorticoids) that can damage the kidneys and heart.

Kerendia is used to treat adults with chronic kidney disease(with an abnormal presence of the protein albumin in the urine) associated with type 2 diabetes.

Chronic kidney disease is a long-term disease. The kidneys are gradually failing to remove waste and fluids from the blood.

Type 2 diabetes occurs when the body cannot maintain normal blood sugar levels. The body does not produce enough insulin or cannot use insulin properly. This leads to high blood sugar levels.

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 infection)
• clarithromycin, telithromycin(to treat bacterial infections)
• nefazodone(to treat depression).
• if you have Addison's disease(when your body does not produce enough "cortisol" and "aldosterone" hormones).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Kerendia if

• you have ever been told you have a high level of potassium in your blood.
• you have severe kidney impairment or kidney failure.
• you have moderate or severe liver problems.
• you have mild, moderate or severe heart failure. This occurs when your heart does not pump blood as well as it should. It does not pump enough blood out of the heart with each beat.

Blood tests

These tests check your potassium level and your kidney function.

Based on the results of your blood tests, your doctor will decide if you can start taking Kerendia.

After 4 weeks of taking Kerendia, you will have new blood tests.

Your doctor may also have your blood tested at other times, for example when you take certain medicines.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because it is not known if 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 do a blood test to make sure.

Do not takemedicines that belong to the group of "strong CYP3A4 inhibitors" while you are taking Kerendia (see section 2 "Do not take Kerendia...").

Ask your doctoror pharmacist if you are takingother medicines while taking Kerendia, especially

• if you take, for example
• amilorideor triamterene(to remove excess water from the body through urine),
• eplerenone, esaxerenone, spironolactone or canrenone (medicines similar to finerenone),
• trimethoprim, or a combination of trimethoprim and sulfamethoxazole(to treat bacterial infections),
• potassium supplements, including some salt substitutes,

or if you take other medicines that may increase your potassium level in the blood. These medicines may not be safe for you.

• if you take, for example

• erythromycin(to treat bacterial infections),
• verapamil(to treat high blood pressure, chest pain and rapid heartbeats),
• fluvoxamine(to treat depression and "obsessive-compulsive disorder"),
• 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 infection),

or if you take other medicines that belong to the same groups of medicines as those mentioned above (certain "inhibitors" and "inducers" of CYP3A4). You may have more side effects or Kerendia may not work as expected.

• if you take other medicines to lower blood pressure. Your doctor may need to check your blood pressure.

Taking Kerendia with food and drinks

Do not eat grapefruit or drink grapefruit juicewhile you are taking Kerendia.

If you do, you may have too much finerenone in your blood. You may have more side effects(the 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

Do not takethis medicine during pregnancy unless your doctor considers it clearly necessary. There may be a risk for your unborn baby. Your doctor will discuss this with you.

You should use a reliable method of contraceptionif you can become pregnant. Your doctor will tell you which contraceptive method you can use.

Breast-feeding

Do not breast-feedwhile you are taking this medicine. It may harm your baby.

Driving and using machines

Kerendia does not affect your ability to drive or use machines.

Kerendia contains lactose

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

Kerendia contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Kerendia

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

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

• Always take 1 tablet once a day. Each tablet contains 10 mg or 20 mg of finerenone.
• The initial dosedepends on how well your kidneys are working. To check this, your doctor will do a blood test. The results will help your doctor decide if you can start with 1 tablet of 20 mg or 10 mgonce a day.
• After 4 weeks, your doctor will do another blood test. Your doctor will decide the correct dose for you. This may be 1 tablet of 20 mg or 10 mgonce a day. Your doctor may also tell you to stop or interrupt taking Kerendia.

Your doctor may decide to change your treatmentafter having your blood tested. 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 will help you remember it.

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 "Taking Kerendia with food and drinks" in section 2 for more information.

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

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

If you take more Kerendia than you should

Ask your doctor or pharmacist for advice if you think you have taken too much of this medicine.

If you forget to take Kerendia

If you forget to take the tablet at the usual time that day

take the tablet as soon as you remember that day.

If you miss a day

take the next tablet the following day, at the usual 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 to do so. Your doctor may decide this after having your blood tested.

If you have any other questions 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 may see in your blood test results

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

• high level of potassium (hyperkalemia)
• The possible signs of a high level of potassium in the blood may be weakness or tiredness, nausea, numbness of the hands and lips, muscle cramps or decreased heart rate.

Common(may affect up to 1 in 10 people)

• low level of sodium (hyponatremia)
• The possible signs of a low level of sodium in the blood may include nausea, tiredness, headache, confusion; muscle weakness, spasms or cramps.
• decreased kidney function (decreased glomerular filtration rate)
• high level of uric acid (hyperuricemia).

Uncommon(may affect up to 1 in 100 people)

• decreased level of a protein (hemoglobin) found in red blood cells.

Other side effects

Common(may affect up to 1 in 10 people)

• low blood pressure (hypotension)
• The possible signs of low blood pressure may be dizziness, lightheadedness or fainting.
• itching (pruritus)

Reporting of side effects

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.

5. Storage of 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, label of the bottle and the carton after EXP/CAD. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Kerendia contains

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

Appearance and packaging

Kerendia 10 mg film-coated tabletsare pink, oval, 10 mm long and 5 mm wide, marked with "10" on one side and "FI" on the other.

Kerendia 20 mg film-coated tabletsare yellow, oval, 10 mm long and 5 mm wide, marked with "20" on one side and "FI" on the other.

Kerendia is available in packs containing

• 14, 28 or 98 film-coated tablets.

Each transparent calendar blister pack contains 14 film-coated tablets.

• 100 x 1 film-coated tablet.

Each transparent unit-dose blister pack 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

You can ask for more information about this medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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