Kerendia 10 mg comprimidos recubiertos con pelicula

Product Information for the Patient

Kerendia 10 mg Film-Coated Tablets

Kerendia 20 mg Film-Coated Tablets

finerenona

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. See section 4.

Kerendia contains the active ingredient finerenone. Finerenone acts by blocking the action of certain hormones (mineralocorticoids) that may damage the kidneys and heart.

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

Chronic kidney disease is a long-term disease. The kidneys are gradually eliminating the blood's waste and liquids less effectively.

Type 2 diabetes is produced when the body cannot maintain normal blood sugar levels. The body does not produce sufficient amounts of the hormone insulin or cannot use insulin properly. This leads to elevated blood sugar levels.

Do not take Kerendia

• if you areallergicto 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
• itraconazoleorketoconazole(to treat fungal infections)
• ritonavir,nelfinavirorcobicistat(to treat HIV infection)
• clarithromycin, telithromycin(to treat bacterial infections)
• nefazodone(to treat depression).
• if you haveaddison's disease(when your body does not produce enough of the hormones “cortisol” and “aldosterone”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kerendia if

• you have ever been told that you have high levels of potassium in your blood.
• you have severe kidney function loss or renal insufficiency.
• 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 testscheck your potassium level and 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 test your blood at other times, for example, when you take certain medicines.

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age because it has not yet been proven to be safe and effective in this age group.

Other medicines and Kerendia

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine. 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 taking Kerendia (see section 2 “Do not take Kerendia…”).

Consult your doctoror pharmacistif you are takingother medicines while taking Kerendia, particularly

• if you take, for example
• amilorideortriamterene(to eliminate excess water from the body through urine),
• eplerenone, esaxerenone, spironolactone or canrenone (similar medicines to finerenone),
• trimethoprim, or acombination 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, phenytoinorphenobarbital(to treat epilepsy),
• St. John's Wort(Hypericum perforatum) (a plant-based 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 othermedicines to lower blood pressure. Your doctor may need to monitor your blood pressure.

Taking Kerendia with food and drinks

Do not eat grapefruit or drink grapefruit juicewhile taking Kerendia.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

You mustuse a reliable contraceptive methodif you can become pregnant. Your doctor will explain which type of contraceptive you can use.

Breastfeeding

Do not breastfeedwhile taking this medicine. It may harm your baby.

Driving and operating machines

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

Kerendia contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Kerendia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much do I have to take

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

• Take always1 tablet once a day. Each tablet contains 10 mg or 20 mg of finerenone.
• Theinitial dosedepends on how your kidneys are functioning. For this, your doctor will make a blood test. The results will help your doctor decide if you can start with1 tablet of 20 mg or 10 mg once a day.
• After 4 weeks, your doctor will make another blood test. Your doctor will decide the correct dose for you. This may be1 tablet of 20 mg or 10 mg once a day. Your doctor may also tell you to interrupt or stop taking Kerendia.

Your doctor may decide to introducechanges in your treatmentafteranalyzing your blood. See “Blood test” in section 2 for more information.

How to take this medication

Kerendia is taken by mouth. Take Kerendia at the same time every day. This will make 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 “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 applesauce.
• Take it immediately.

If you take more Kerendia than you should

Consult your doctor or pharmacist if you think you have taken too much of this medication.

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 next day, atthe usual time.

Do not take 2 tablets to make up for a missed tablet.

If you interrupt the treatment with Kerendia

Only interruptthe treatment with Kerendia if your doctor has told you to do so. Your doctor may decide this after analyzing your blood.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects that your doctor may observe in your blood test results

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

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

Common(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

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

Other adverse effects

Common(may affect up to 1 in 10 people)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, bottle label, and box after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Kerendia

• The active ingredient is finerenone.
• Each film-coated tablet ofKerendia 10 mg film-coated tabletscontains 10 mg of finerenone.
• Each film-coated tablet ofKerendia 20 mg film-coated tabletscontains 20 mg of finerenone.
• The other components 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 Kerendia10 mg film-coated tablets) and yellow iron oxide (E 172, only in Kerendia20 mg film-coated tablets).

Appearance of the product and contents of the pack

Kerendia10 mg film-coated tabletsare pink, ovaloid-oblong tablets, 10 mm in length and 5 mm in width, marked with “10” on one face and “FI” on the other.

Kerendia20 mg film-coated tabletsare yellow, ovaloid-oblong tablets, 10 mm in length and 5 mm in width, marked with “20” on one face and “FI” on the other.

Kerendia is available in packs containing

• 14, 28 or 98 film-coated tablets.

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

• 100 × 1 film-coated tablet.

Each pre-cut, single-dose transparent blister pack contains 10 film-coated tablets.

• 100 film-coated tablets in a plastic bottle.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of the last revision of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.