20 mg, 40 mg, 80 mg tablets 
azilsartan medoxomil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Edarbi is and what it is used for 
2. What you need to know before taking Edarbi 
3. How to take Edarbi 
4. Possible side effects 
5. How to store Edarbi 
6. Contents of the packaging and other information 

1. What Edarbi is and what it is used for

Edarbi contains an active substance called azilsartan medoxomil which belongs to a group of medicines called angiotensin II receptor inhibitors. Angiotensin II is a body-specific substance that causes the blood vessels to constrict, leading to a rise in blood pressure. Edarbi prevents this effect, which causes the blood vessels to dilate and the blood pressure to drop.

This medicine is used to treat high blood pressure ( essential hypertension ) in adult patients (older than 18 years).

A decrease in blood pressure will be measurable within 2 weeks of starting treatment and the full effect of a dose will be seen within 4 weeks.

2. What you need to know before taking Edarbi

Do NOT take Edarbi if you

  • is allergic (hypersensitive) to azilsartan medoxomil or any of the other ingredients of Edarbi (see section 6).
  • during the last 6 months of pregnancy (even earlier during pregnancy it is good to avoid Edarbi – see the section on pregnancy).
  • have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and cautions

Talk to your doctor before taking Erdabi, especially if you:

  • have kidney problems,
  • undergoing dialysis or a recent kidney transplant,
  • had severe liver disease,
  • have heart problems (including heart failure  recent heart attack),
  • have had a stroke,
  • have low blood pressure, or feel dizzy or close to fainting,
  • have vomiting, recently had vomiting or have diarrhea,
  • have elevated potassium levels in the blood (manifested in blood tests),
  • have an adrenal disease called primary hyperaldosteronism
  • have been told that you have narrowing of the heart valves (called aortic or mitral valve stenosis) or that your heart muscle is abnormally thick (called obstructive hypertrophic cardiomyopathy )
  • take any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take Edarbi”.

If you think you are or will become pregnant during treatment, consult your doctor. Edarbi is not recommended in early pregnancy and should NOT be taken during the last 6 months of pregnancy as it may cause birth defects (see section “Pregnancy and breast-feeding”). Edarbi may be less effective in lowering blood pressure in black patients.

Children and young people

There are limited data on the use of Edarbi in children and adolescents under 18 years of age. Therefore, this medicine should not be given to children or adolescents.

Other medicines and Edarbi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Edarbi may affect the effectiveness of other medicines and some medicines may affect the effect of Edarbi.

In particular, tell your doctor if you are taking any of the following medicines:

  • lithium (a medicine for mental illness),
  • non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen, diclofenac, or celecoxib (medicines to relieve pain and inflammation ),
  • acetylsalicylic acid if taken more than three times a day (medicines to relieve pain and inflammation )
  • medicines that increase the level of potassium in the blood, including potassium supplements, potassium-sparing medicines (certain “diuretic tablets”), or salt substitutes containing potassium,
  • heparin (a blood-thinning drug),
  • diuretics ( diuretic tablets),
  • aliskiren or other medications to lower blood pressure Et (angiotensinkovertashämmare such as enalapril , lisinopril, ramipril, angiotensin -II- receptor blocker such as valsartan, telmisartan and irbesartan).

Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Edarbi” and “Warnings and precautions”).

Pregnancy and breastfeeding

Pregnancy

If you think you are or will become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking this medicine before pregnancy or as soon as you know you are pregnant and instead recommend a medicine other than Edarbi to you.

Edarbi is not recommended in early pregnancy and should NOT be taken during the last 6 months of pregnancy as it may cause mumps.

Breast-feeding

Tell your doctor if you are breast-feeding. Edarbi is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.

Driving and using machines

Edarbi probably does not affect the ability to drive or use machines. However, some people may experience fatigue or dizziness while taking this medicine and if this happens to you, do not drive or use any tools or machines.

3. How to take Edarbi

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. You must take Edarbi every day, at the same time. Edarbi should be swallowed. Take the tablet with plenty of water.

You can take this medicine with or without food.

  • The usual starting dose is 40 mg once a day. Depending on your blood pressure response, your doctor may increase the dose to a maximum of 80 mg once a day.
  • For patients who are much older (75 years and older), the doctor may recommend a lower starting dose of 20 mg once daily.
  • If you suffer from mild to moderate liver disease, your doctor may recommend a lower starting dose of 20 mg once a day.
  • For patients who have recently lost body fluids e.g. by vomiting or diarrhea, or having taken diuretic tablets, your doctor may recommend a lower starting dose of 20 mg once daily.
  • If you also suffer from other diseases such as severe kidney disease or heart failure, your doctor will choose the most appropriate starting dose.

If you take more Edarbi then you should

Contact your doctor immediately if you have taken too many tablets or if someone else has taken your medicine. You may feel dizzy or dizzy if you take more than you should.

If you forget to use Edarbi

Do not take a double dose to make up for a forgotten dose. Just 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 first talking to your doctor about alternative treatments.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Edarbi immediately and contact a doctor if you have 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 on the skin with raised calluses.

Other possible side effects are:

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

  • Dizziness
  • Diarrhea
  • Elevated creatine phosphokinase in the blood (indicates muscle damage).

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

  • Low blood pressure can make you feel dizzy or dizzy
  • Fatigue
  • Swollen hands, ankles, or feet (peripheral edema )
  • Skin rash and itching
  • Nausea
  • Muscle spasms
  • Elevated serum creatinine in the blood (shows your kidney function)
  • Increased levels of uric acid in the blood.

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

  • Altered blood test results, including lowering of a protein in the red blood cells ( hemoglobin ).

When Edarbi is taken with chlorthalidone (a diuretic ), higher levels of certain substances in the blood (eg creatinine, which shows kidney function) have been common (in less than 1 in 10 users) and low blood pressure is also common.

Swollen hands, ankles,s or feet are more common (in less than 1 in 10 people) when Edarbi is taken with amlodipine (a calcium antagonist used to treat high blood pressure ) than when only Edarbi is taken (less than 1 in 100 users). The effect occurs more often when amlodipine is taken alone.

5. How to store Edarbi

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 carton after EXP. The expiration date is the last day of the specified month.

Store Edarbi in the original package. Sensitive to light. Moisture sensitive.

No special temperature instructions.

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 packaging and other information

Content declaration

  • The active substance is azilsartan medoxomil (as potassium ).

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

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

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

  • The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

What the medicine looks like and the contents of the pack

The tablets are white and round, with “ASL” embossed on one side and “20”, “40” or “80” on the other side.

Edarbi is supplied in blister packs of either 14 tablets or 15 tablets in cartons containing 14, 28, 56, or 98 tablets and in blister packs of desiccant containing either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

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

Contact the representative of the marketing authorization holder to find out more about this medicine:


Belgium / Belgique / BelgienTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com
LithuaniaTakeda UABTel: +370 521 09 070lt-info@takeda.com

BulgariaTakade BulgariaTel .: +359 2 958 27 36; +359 2 958 15 29
Luxembourg / LuxemburgTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com

Czech RepublicTakeda Pharmaceuticals Czech Republic sroTel: +420 234 722 722
HungaryTakeda Pharma Kft.Tel: +361 2707030

DenmarkTakeda Pharma A / STel: +45 46 77 11 11
MaltaTakeda Italia SpATel: +39 06 5026 01

GermanyTakeda GmbHTel: 0800 825 3325medinfo@takeda.de
The NetherlandsTakeda Nederland bvTel: +31 23 566 8777nl.medical.info@takeda.com

EestiTakeda Pharma ASTel: +372 6177 669
NorwayTakeda ASTel: + 47 6676 3030infonorge@takeda.com

GreeceΒΙΑΝΕΞ Α.Ε.:Ηλ: +30 210 80 09 111 120
AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800-20 80 50
SpainTakeda Pharmacéutica España SATel: +34 917 90 42 22spain@takeda.com PolandTakeda Pharma sp. z ooTel: +48 22 608 13 00
FranceTakeda France SASTel: +33 1 46 25 16 16 PortugalTecnimede – Técnico-Medicinal Sociedade, SA Tel: +351 21 041 41 00dmed.fv@tecnimede.pt
CroatiaTakeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96 RomaniaTakeda Pharmaceuticals SRLTel: +40 21 335 03 91
IrelandTakeda Products Ireland LimitedTel: +44 (0) 1628 537 900 SloveniaTakeda GmbH, Podružnica SlovenijaTel: +386 (0) 59 082 480
IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600
ItalyTakeda Italia SpATel: +39 06 5026 01 Finland / FinlandTakeda OyPuh / Tel: +358 20 746 5000
LatviaTakeda Latvia SIATel: +371 67840082 United KingdomTakeda UK LtdTel: +44 (0) 1628 537 900

Muhammad Nadeem

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