EDARBI 40 mg TABLETS

Introduction

Prospect: Information for the User

Edarbi 20 mg Tablets

Edarbi 40 mg Tablets

Edarbi 80 mg Tablets

Azilsartan Medoxomil

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the Prospectus:

1. What Edarbi is and what it is used for

1. What you need to know before taking Edarbi

1. How to take Edarbi

1. Possible side effects

1. Storage of Edarbi

1. Package contents and additional information

1. What Edarbi is and what it is used for

Edarbi contains the active ingredient azilsartan medoxomil and belongs to a class of medications called angiotensin II receptor antagonists (ARAII). Angiotensin II is a substance that is naturally produced in the body and causes blood vessels to constrict, increasing blood pressure. Edarbi blocks this effect, causing blood vessels to relax, which helps to reduce blood pressure.

This medication is used to treat high blood pressure (essential hypertension) in adult patients (over 18 years of age).

A reduction in blood pressure should be observed within 2 weeks of starting treatment, and the full effect of the dose should be observed before 4 weeks have passed.

2. What you need to know before taking Edarbi

Do not take Edarbi if

• you are allergicto azilsartan medoxomil or any of the other components of this medication (listed in section 6).
• you are pregnant for more than 3 months.(It is also recommended to avoid taking this medication at the start of pregnancy; see the section on pregnancy).
• you have diabetes mellitus or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Edarbi, especially if:

• you have kidney problems

• you are being treated with dialysis or have recently undergone a kidney transplant.

• you have severe liver disease

• you have heart problems (such as heart failure or recent heart attack)

• you have had a stroke

• you have low blood pressure or feel dizzy or lightheaded

• you vomit, have recently had severe vomiting, or have diarrhea

• you have high levels of potassium in your blood (as shown by blood tests)

• you have a disease of the adrenal gland called primary hyperaldosteronism

• you have been told that you have a narrowing of the heart valves (called "aortic or mitral valve stenosis") or that the thickness of your heart muscle is abnormally increased (called "hypertrophic obstructive cardiomyopathy")

• you are taking any of the following medications used to treat high blood pressure (hypertension):

1. an angiotensin-converting enzyme inhibitor (ACEI) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

1. aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the headings "Do not take Edarbi" and "Warnings and precautions".

You should inform your doctor if you think you are pregnant (or if you plan to become pregnant). Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant, and will recommend taking a different medication instead of Edarbi. It is not recommended to use Edarbi at the start of pregnancy, and IN NO CASE should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see the section on pregnancy and breastfeeding).

Edarbi may be less effective in reducing blood pressure in black patients.

Children and adolescents

There is only limited data available on the use of Edarbi in children or adolescents under 18 years of age.

Therefore, this medication should not be administered to children or adolescents.

Other medications and Edarbi

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Edarbi may affect the way other medications work, and some medications may affect Edarbi.

In particular, inform your doctor if you are taking any of the following medications:

• Lithium (a medication used for mental health problems)

• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, or celecoxib (medications used to relieve pain and inflammation)

• Acetylsalicylic acid if you are taking more than 3 g per day (a medication used to relieve pain and inflammation)

• Medications that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing diuretics, or salt substitutes with potassium content

• Heparin (a medication used to thin the blood)

• Diuretics

• Aliskiren or other medications used to reduce blood pressure (angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, such as enalapril, lisinopril, ramipril, or valsartan, telmisartan, irbesartan).

Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also the information under the headings "Do not take Edarbi" and "Warnings and precautions").

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or if you plan to become pregnant). Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant, and will recommend taking a different medication instead of Edarbi. It is not recommended to use Edarbi at the start of pregnancy, and IN NO CASE should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see the section on pregnancy and breastfeeding).

Breastfeeding

Inform your doctor if you are breastfeeding, as it is not recommended to use Edarbi during breastfeeding. Your doctor may choose a different treatment for you that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

It is unlikely that Edarbi will affect your ability to drive or use machines. However, some people may feel tired or dizzy when taking this medication, and if this happens to you, do not drive or use tools or machines.

3. How to take Edarbi

Follow the instructions for taking this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. It is important to continue taking Edarbi every day at the same time.

Edarbi is for oral use. Take the tablet with a large amount of water.

You can take this medication with or without food.

• The usual initial dose is 40 mg once a day. Your doctor may increase this dose to a maximum of 80 mg once a day, depending on your blood pressure response.
• In patients who are very elderly, for example (over 75 years), your doctor may recommend a lower initial dose of 20 mg once a day.
• If you have mild or moderate liver disease, your doctor may recommend a lower initial dose of 20 mg once a day.
• In patients who have recently lost body fluid, for example due to vomiting or diarrhea or due to taking diuretics, your doctor may recommend a lower initial dose of 20 mg once a day.

• If you have any other underlying disease, such as kidney disease or heart failure, your doctor will decide on the most suitable initial dose.

If you take more Edarbi than you should

If you take too many tablets or if someone else takes your medication, contact your doctor immediately. You may feel weak or dizzy if you take more than you should.

If you forget to take Edarbi

Do not take a double dose to make up for forgotten doses. Simply take the next dose at the usual time.

If you stop taking Edarbi

If you stop taking Edarbi, your blood pressure may rise again. Therefore, do not stop taking Edarbi without consulting your doctor first about alternative treatment options.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Edarbi and consult a doctor immediately if you experience any of the following allergic reactions, which occur rarely (may affect up to 1 in 1,000 people):

• Difficulty breathing, or swallowing, or swelling of the face, lips, tongue, and/or throat (angioedema)

• Itching of the skin with hives.

Other possible side effects:

Common side effects (may affect up to 1 in 10 people):

• Dizziness

• Diarrhea

• Increased creatine phosphokinase in the blood (an indicator of muscle damage).

Uncommon side effects (may affect up to 1 in 100 people):

• Low blood pressure, which may make you feel weak or dizzy

• Feeling tired

• Swelling of the hands, ankles, or feet (peripheral edema)

• Skin rash, itching

• Nausea

• Muscle spasms

• Increased serum creatinine in the blood (an indicator of kidney function)

• Increased uric acid in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

• Changes in blood test results, including a decrease in hemoglobin levels (a protein in red blood cells).

When Edarbi is taken with chlorthalidone (a diuretic), the following have been commonly observed (in less than 1 in 10 users): higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, and low blood pressure.

Swelling of the hands, ankles, or feet is more common (in less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium channel blocker to treat hypertension) than when Edarbi is taken alone (less than 1 in 100 users). The frequency of this effect is higher when amlodipine is taken alone.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Edarbi

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Store Edarbi in its original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Edarbi

• The active ingredientis azilsartan medoxomil (as potassium).

Edarbi 20 mg:each tablet contains 20 mg of azilsartan medoxomil (as potassium)

Edarbi 40 mg:each tablet contains 40 mg of azilsartan medoxomil (as potassium)

Edarbi 80 mg:each tablet contains 80 mg of azilsartan medoxomil (as potassium)

• The other ingredientsare mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, sodium croscarmellose, microcrystalline cellulose, and magnesium stearate.

Appearance and packaging of the product

The tablets are round and white, engraved with "ASL" on one side and "20", "40", or "80" on the other.

Edarbi is available in blister packs, each containing 14 or 15 tablets, in boxes containing 14, 28, 56, or 98 tablets, or integrated blister packs with desiccant, each containing 14 or 15 tablets, in boxes containing 14, 28, 30, 56, 90, or 98 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark

Manufacturer:

Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland

You can obtain further information on this medication by contacting the local representative of the marketing authorization holder:

Belgium/Belgique/BelgienLithuania

Takeda Belgium Takeda UAB

Tel: +32 2 464 06 11 Tel: +370 521 09 070

takeda-belgium@takeda.com lt-info@takeda.com

BulgariaLuxembourg/Luxemburg

Takeda Pharma GmbH Takeda Belgium

Tel: +359 2 958 27 36; +359 2 958 15 29 Tel: +32 2 464 06 11

takeda-belgium@takeda.com

Czech RepublicHungary

Takeda Pharmaceuticals Czech Republic s.r.o Takeda Pharma Kft.

Tel: +420 234 722 722 Tel: +361 2707030

DenmarkMalta

Takeda Pharma A/S Takeda Italia S.p.A.

Tel: +45 46 77 11 11 Tel: +39 06 5026 01

GermanyNetherlands

Takeda GmbH Takeda Nederland bv

Tel: 0800 825 3325 Tel: +31 23 566 8777

medinfo@takeda.de nl.medical.info@takeda.com

EstoniaNorway

Takeda Pharma AS Takeda AS

Tel: +372 6177 669 Tel: +47 6676 3030

infonorge@takeda.com

GreeceAustria

ΒΙΑΝΕΞ Α.Ε. Takeda Pharma Ges.m.b.H.

Τηλ: +30 210 80 09 111 120 Tel: +43 (0) 800-20 80 50

SpainPoland

Takeda Farmacéutica España S.A Takeda Pharma sp. z o.o.

Tel: +34 917 90 42 22 Tel: +48 22 608 13 00

spain@takeda.com

FrancePortugal

Takeda France S.A.S Tecnimede - Sociedade Técnico-Medicinal, S.A

Tel: +33 1 46 25 16 16 Tel: +351 21 041 41 00

dmed.fv@tecnimede.pt

CroatiaRomania

Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL

Tel: +385 1 377 88 96 Tel: +40 21 335 03 91

IrelandSlovenia

Takeda Products Ireland Limited Takeda GmbH, Podružnica Slovenija

Tel: +44 (0) 1628 537 900 Tel: +386 (0) 59 082 480

IcelandSlovakia

Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o

Tel: +354 535 7000 Tel: +421 (2) 20 602 600

vistor@vistor.is

ItalyFinland

Takeda Italia S.p.A. Takeda Oy

Tel: +39 06 5026 01 Tel: +358 20 746 5000

CyprusSweden

Takeda Pharma A/S Takeda Pharma AB

Tel: +45 46 77 11 11 Tel: +46 8 731 28 00

infosweden@takeda.com

LatviaUnited Kingdom

Takeda Latvia SIA Takeda UK Ltd

Tel: +371 67840082 Tel: +44 (0) 1628 537 900

Date of the last revision of this prospectus:

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