Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kerendia

Document Subject

Generated Narrative: MedicinalProductDefinition mpea2d9477557df2cb8572d829cd765247

identifier: http://ema.europa.eu/identifier/EU/1/21/1616/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kerendia 10 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ea2d9477557df2cb8572d829cd765247

identifier: http://ema.europa.eu/identifier/EU/1/21/1616/001-005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kerendia

Attesters

What is in 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

Kerendia contains the active substance finerenone. Finerenone works by blocking the action of certain hormones (mineralocorticoids) that can damage your kidneys and 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-term condition. Your kidneys keep getting worse at removing waste and fluids from your blood. Type 2 diabetes is when your body cannot keep your blood sugar levels normal. Your body does not produce enough of the hormone insulin or cannot use the insulin properly. This leads to a high level of sugar in your blood.

Do not take Kerendia if you

• are allergic to finerenone or any of the other ingredients of this medicine (listed in section 6).
• are taking medicines that belong to the group of strong CYP3A4 inhibitors , for example
• itraconazole or ketoconazole (to treat fungal infections)
• ritonavir, nelfinavir, or cobicistat (to treat HIV infection)
• clarithromycin, telithromycin (to treat bacterial infections)
• nefazodone (to treat depression).
• 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 taking Kerendia if you have

• ever been told you had a high level 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 is when your heart does not pump blood as well as it should. It does not pump enough blood out of the heart in one beat.

Blood tests These tests check your potassium level and how your kidneys are working. Using the results of your blood tests, your doctor decides whether you can start to take Kerendia. After 4 weeks of taking Kerendia, you will have more blood tests. Your doctor may test your blood 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 because it is not known yet 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 tell you which medicines you can take. Your doctor may need to test your blood to make sure.

You must not take medicines that belong to the group of strong CYP3A4 inhibitors, while taking Kerendia (see section 2 Do not take Kerendia ).

Talk to your doctor or pharmacist if you are taking other medicines while taking Kerendia, especially

• if you take for example

• amiloride or triamterene (to remove excess water from your body in the 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 the level of potassium in your blood. These medicines may be unsafe for you.

• if you take for example

• erythromycin (to treat bacterial infections)

• verapamil (to treat high blood pressure, chest pain, and fast heartbeat)

• 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 to treat depression)

• efavirenz (to treat HIV infection) or if you take other medicines that belong to the same groups of medicines as the ones listed above (certain CYP3A4 inhibitors and inducers ). You may have more side effects, or Kerendia may not work as expected.

• if you take several other blood pressure lowering medicines. Your doctor may need to watch your blood pressure.

Kerendia with food and drink Do not eat grapefruit or drink grapefruit juice as long as you take Kerendia. If you do, you may get too much finerenone in your blood. You may have more side effects (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 You should not take this medicine during pregnancy unless your doctor states it is clearly necessary. There might be a risk to your unborn baby. Your doctor will discuss that with you. You should use reliable birth control if you are able to become pregnant. Your doctor will explain to you what type of birth control you can use.

Breast-feeding You should not breast-feed while taking this medicine. It may harm your baby.

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

Kerendia contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Kerendia contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much you have to take The recommended and the 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 finerenone.
• The starting dose depends on how well your kidneys work. To check this your doctor will test your blood. The results help your doctor to decide, if you can start with 1 tablet of 20 mg or 10 mg once daily.
• After 4 weeks your doctor will test your blood again. Your doctor will decide on the correct dose for you. This might be 1 tablet of 20 mg or 10 mg once daily. Your doctor may also tell you to interrupt or stop taking Kerendia.

Your doctor may decide on changes in your treatment after testing your blood. 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 makes 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 Kerendia with food and drink in section 2 for more information.

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

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

If you take more Kerendia than you should Talk to 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 your tablet at your regular time that day take the tablet as soon as you notice it that day.

If you miss a day take the next tablet on the next day, at your regular 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. Your doctor may decide this after testing your blood.

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

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

common (may affect up to 1 in 10 people)

• low sodium level (hyponatraemia) Possible signs of low sodium level in the blood may include feeling sick (nausea), tiredness, headache, confusion; muscle weakness, spasms or cramps.
• decrease in how well the kidneys filter blood (glomerular filtration rate decreased).
• high uric acid level (hyperuricaemia)

uncommon (may affect up to 1 in 100 people)

• decrease in a protein (haemoglobin) that is found in your 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 (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.

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, bottle label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Kerendia contains

• The active substance is finerenone.

• Each tablet of Kerendia 10 mg film-coated tablets contains 10 mg finerenone.

• Each tablet of Kerendia 20 mg film-coated tablets contains 20 mg finerenone.

• The other ingredients are:

• Tablet core: microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate. See Kerendia contains lactose and Kerendia contains sodium in section 2 for more information.

• Tablet coat: hypromellose 2910, titanium dioxide, talc, iron oxide red (E 172, in Kerendia 10 mg film-coated tablets only), iron oxide yellow (E 172, in Kerendia 20 mg film-coated tablets only).

What Kerendia looks like and contents of the pack Kerendia 10 mg film-coated tablets (tablets) are pink and oval-oblong, 10 mm long and 5 mm wide, marked 10 on one side and FI on the other side.

Kerendia 20 mg film-coated tablets (tablets) are yellow and oval-oblong, 10 mm long and a 5 mm wide, marked 20 on one side and FI on the other side.

Kerendia is available in cartons containing

• 14, 28 or 98 film-coated tablets.

Each calendarised transparent blister contains 14 film-coated tablets.

• 100 1 film-coated tablets.

Each perforated transparent unit dose 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +37 05 23 36

T .: +359 02 4247Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel: +36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-(0)23-799 1Eesti Bayer O
Tel: +372 655 8Norge Bayer AS Tlf: +47 23 13 05
Bayer
: +30-210-61 87 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer SRL Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 8 1 Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785
NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: