Kerendia 10 mg film-coated tablets

Package leaflet: Information for the user

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 quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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. Finerenone 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 an abnormal presence of the protein albumin in the urine) associated with type 2 diabetes.

Chronic kidney disease is a long-term condition in which the kidneys gradually lose their ability to properly remove waste products and fluids from the blood.

Type 2 diabetes occurs when the body cannot maintain normal blood sugar levels. This happens because the body does not produce enough of the hormone insulin or cannot use insulin properly, leading to high levels of sugar in the blood.

2. What you need to 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 infection)
• clarithromycin, telithromycin (used to treat bacterial infections)
• nefazodone (used to treat depression).
• if you have Addison’s disease (when your body does not produce enough of the hormones “cortisol” and “aldosterone”).

Warnings and precautions

Talk to your doctor or pharmacist before starting Kerendia if:

• you have ever been told that you have high levels 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, meaning it does not pump enough blood out of the heart with each beat.

Blood tests

These tests check your potassium levels and kidney function.

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

Four weeks after starting Kerendia, you will have another blood test.

Your doctor may also perform blood tests at other times, for example, when you are taking certain medications.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it is not known 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 need to take any other medicines. Your doctor will advise you which medicines are safe to take. Your doctor may need to perform a blood test to make sure.

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

Consult your doctor or pharmacist if you are taking other medicines while on Kerendia, particularly:

• if you are taking, for example:
• amiloride or triamterene (to remove excess fluid from the body via 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 certain salt substitutes,

or if you are taking other medicines that may increase your blood potassium levels. These medicines may not be safe for you.

• if you are taking, for example:
• erythromycin (to treat bacterial infections),
• verapamil (to treat high blood pressure, chest pain, and rapid heart rate),
• fluvoxamine (to treat depression and “obsessive-compulsive disorder”),
• rifampicin (to treat bacterial infections),
• carbamazepine, phenytoin, or phenobarbital (to treat epilepsy),
• St. John’s wort (Hypericum perforatum) (a herbal medicine used to treat depression),
• efavirenz (to treat HIV infection),

or if you are taking other medicines belonging to the same groups as those listed above (certain “inhibitors” and “inducers” of CYP3A4). You may experience more side effects or Kerendia may not work as expected.

• if you are taking other medicines to lower blood pressure. Your doctor may need to monitor your blood pressure.

Taking Kerendia with food and drink

Do not eat grapefruit or drink grapefruit juice while taking Kerendia.

Doing so may lead to higher levels of finerenone in your blood. You may experience more side effects (possible side effects are listed in section 4).

Pregnancy and breastfeeding

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

Pregnancy

You must not take this medicine during pregnancy unless your doctor considers it clearly necessary. There may be a risk to your unborn baby. Your doctor will discuss this with you.

You should use a reliable method of contraception if you are capable of becoming pregnant. Your doctor will advise you on which type of contraception is suitable.

Breastfeeding

You must not breastfeed while taking this medicine. It may harm your baby.

Driving and using machines

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

Kerendia contains lactose

If your doctor has informed 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; hence, it is essentially “sodium-free”.

3. How to take Kerendia

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 starting dose depends on how well your kidneys are functioning. To check this, your doctor will perform a blood test. The results will help your doctor decide whether you should start with 1 tablet of 20 mg or 10 mg once a day.
• After 4 weeks, your doctor will perform another blood test. Your doctor will then decide the correct dose for you, which may be 1 tablet of 20 mg or 10 mg once a day. Your doctor may also instruct you to interrupt or stop taking Kerendia.

Your doctor may decide to make changes to your treatment after blood testing. 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 make it easier for you to remember.

Swallow the tablet whole.

• You may take it with a glass of water.
• You may take it with or without food.
• Do not take it with grapefruit juice or grapefruit. See "Taking Kerendia with food and drink" in section 2 for more information.

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

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

If you take more Kerendia than you should

Contact 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 the tablet at the usual time that day,

?taking 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 instructed you to do so. Your doctor may make this decision after performing a blood test.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects that your doctor may observe in the results of your blood tests

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

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

Common (may affect up to 1 in 10 people)

• low sodium levels (hyponatraemia)
  Possible signs of low sodium levels in the blood may include nausea, tiredness, headache, confusion, muscle weakness, spasms, or cramps.
• reduced kidney ability to filter blood (decreased glomerular filtration rate)
• high uric acid levels (hyperuricaemia)

Uncommon (may affect up to 1 in 100 people)

• decrease in a protein (haemoglobin) found in red blood cells

Other adverse effects

Common (may affect up to 1 in 10 people)

• low blood pressure (hypotension)
  Possible signs of low blood pressure may include dizziness, lightheadedness, or fainting.
• itching (pruritus)

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister, the label of the bottle, and the carton following EXP/CAD. The expiry date refers to the last day of the month indicated.

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 and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kerendia

• 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, 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 of the product and contents of the pack

Kerendia 10 mg film-coated tablets are pink, oval-oblong tablets, 10 mm long and 5 mm wide, marked with “10” on one side and “FI” on the other.

Kerendia 20 mg film-coated tablets are yellow, oval-oblong tablets, 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 × 1 film-coated tablets.

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

• 100 film-coated tablets in a plastic bottle.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bayer AG
51368 Leverkusen
Germany

Manufacturer

You can find out who manufactured Kerendia by checking what is printed after "Batch" on the carton, blisters or bottle label.

If the batch number starts with "BX", the manufacturer is:

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

If the batch number starts with "IT", the manufacturer is:

Bayer HealthCare Manufacturing S.r.l.
Via delle Groane, 126
20024 Garbagnate Milanese
Italy

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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