EDARBI 20 мг Таблетка

Содержание инструкции

1. Edarbi 20 mg tablets, 40 mg tablets, 80 mg tablets
   1. What is Edarbi and what is it 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. Package contents and other information

Edarbi 20 mg tablets, 40 mg tablets, 80 mg tablets

azilsartan medoxomil

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Edarbi is and what it is used for
• 2. What you need to know before you take Edarbi
• 3. How to take Edarbi
• 4. Possible side effects
• 5. How to store Edarbi
• 6. Contents of the pack and other information

1. What is Edarbi and what is it used for

Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of
medicines called angiotensin II receptor blockers (AIIRAs). Angiotensin II is a
substance found naturally in the body that causes narrowing of the blood vessels,
consequently increasing blood pressure. Edarbi blocks this effect resulting in
relaxation of the blood vessels which helps to reduce blood pressure.
This medicine is used for the treatment of high blood pressure (essential hypertension) in adult
patients (over 18 years of age).
A reduction in blood pressure will be noticeable within 2 weeks of starting therapy and
the full effect will be seen within 4 weeks.

2. What you need to know before taking Edarbi

DO NOT take Edarbi

• if you are allergicto azilsartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months.(It is best to avoid taking this medicine even in the early stages of pregnancy - see the pregnancy section).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Edarbi, especially

• if you have kidney problems.
• if you are on dialysis or have recently had a kidney transplant.
• if you have serious problems with your liver.
• if you have heart problems (including heart failure, recent heart attack).
• if you have had a stroke.
• if you have low blood pressure or feel dizzy or lightheaded.
• if you have vomiting or have recently suffered from severe vomiting or diarrhea.
• if you have high levels of potassium in your blood (evident in blood tests).
• if you have a disorder of the adrenal gland called primary hyperaldosteronism.
• if you have been found to have a narrowing of the heart valves (called “aortic or mitral valve stenosis”) or an abnormal thickening of the heart muscle (called “obstructive hypertrophic cardiomyopathy”).
• if you are taking any of the following medicines used to treat high blood pressure: o an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes. o aliskiren.

Talk to your doctor if, after taking Edarbi, you experience abdominal pain, nausea, vomiting or diarrhea.
The doctor will decide about continuing the treatment. Do not stop taking Edarbi
on your own.
The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(for example potassium) in your blood at regular intervals.
See also what is stated under “Do not take Edarbi”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Edarbi is not recommended in early pregnancy and MUST NOT be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the “Pregnancy and breastfeeding” section). Edarbi may be less effective in
reducing blood pressure in patients of black race.

Children and adolescents
Data on the use of Edarbi in children or adolescents under the age of 18 are limited.
This medicine should therefore 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 medicine.
Edarbi can have effects on the functioning of other medicines and other medicines can have effects
on Edarbi.
In particular, tell your doctor if you are taking any of the following medicines:

• Lithium (a medicine for mental health problems)
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib (painkillers and anti-inflammatory medicines)
• Acetylsalicylic acid if taken in doses higher than 3 g per day (painkiller and anti-inflammatory medicine)
• Medicines that increase the level of potassium in the blood; these include potassium supplements, potassium-sparing medicines (some diuretics) or salt substitutes containing potassium
• Heparin (a medicine to make the blood more fluid)
• Diuretics
• Aliskiren or other medicines that lower blood pressure (angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, such as enalapril, lisinopril, ramipril or valsartan, telmisartan).

The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: “Do not take
Edarbi” and “Warnings and precautions”).

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking this
medicine before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Edarbi.
Edarbi is not recommended in early pregnancy, and MUST NOT be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken after the third
month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding. Edarbi is not recommended for women who are breastfeeding and
the doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is
newborn or premature.

Driving and using machines
It is unlikely that Edarbi will have an effect on driving or using machines. However, some
people may feel tired or dizzy while taking this
medicine and, if this happens, you should avoid driving vehicles or using machines.

Edarbi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Edarbi

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. It is important to take Edarbi every day at the same time.
Edarbi is for oral use. Take the tablet with a glass of water.
You can take this medicine with or without food.

• The usual starting dose is 40 mg once a day. Your doctor may increase this dose up to a maximum of 80 mg once a day depending on the blood pressure response.
• For elderly patients (75 years and over) your doctor may recommend a lower starting dose of 20 mg once a day.
• If you suffer from mild to moderate hepatic impairment, your doctor may recommend a lower starting dose of 20 mg once a day.
• For patients who have recently experienced a loss of body fluids, e.g. due to vomiting or diarrhea or due to the use of diuretics, your doctor may recommend a lower starting dose of 20 mg once a day.
• If you suffer from other concomitant diseases, such as severe kidney disease or heart failure, your doctor will decide what is the appropriate starting dose.

If you take more Edarbi than you should
If you accidentally take too many tablets, or if another person takes your medicine, contact your
doctor immediately. If you take more tablets than you should, you may experience a feeling of
fainting or dizziness.

If you forget to take Edarbi
Do not take a double dose to make up for a missed tablet. Simply continue with the next dose.

If you stop taking Edarbi
If you stop taking Edarbi, your blood pressure may increase again. It is therefore recommended that you do not stop treatment with Edarbi without first agreeing with your doctor on an
alternative treatment.
If you have any further questions on the use of this medicine, 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 and contact your doctor immediately if you experience any of the following allergic reactions, which are rare (may affect up to 1 in 1,000 users):

• Difficulty breathing or swallowing, or swelling of the face, lips, tongue and/or throat (angioedema)
• Itchy skin with rash.

Other possible side effects include:

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

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

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

• Low blood pressure, which can cause a feeling of fainting or dizziness
• Feeling tired
• Swelling of hands, ankles or feet (peripheral edema)
• Skin rash and itching
• Nausea
• Muscle spasms
• Increased 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 the levels of a protein in red blood cells (hemoglobin).

Not known (frequency cannot be estimated from available data):

• Joint pain
• Intestinal angioedema: swelling in the intestine has been reported after use of similar products, manifesting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

If Edarbi is taken with chlortalidone (a diuretic), higher levels of certain chemicals in the blood (such as creatinine), indicators of kidney function, and low blood pressure have been commonly observed (in less than 1 in 10 users).
Swelling of hands, ankles or feet is more common (affects less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium antagonist for the treatment of hypertension) compared to when Edarbi is taken alone (less than 1 in 100 users). The frequency of this effect is higher when amlodipine is taken alone.

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

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 pack after SCAD. The expiry
date refers to the last day of that month.
Store Edarbi in the original package to protect the medicine from light and moisture.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Edarbi contains

• The active substanceis 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, hypromellose, sodium croscarmellose, microcrystalline cellulose and magnesium stearate.

Description of Edarbi and package contents
The tablets are white, round, with “ASL” imprinted on one side and “20”, “40” or “80” on the other.
Edarbi is supplied in blisters of 14 tablets or 15 tablets each in cardboard cartons containing
14, 28, 56 or 98 tablets and in blisters with desiccant of 14 tablets or 15 tablets each in
cardboard cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark

Manufacturer
Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
Ireland
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf.: +45 46 77 10 10
[email protected]

Malta
Τakeda Pharma A/S
Τηλ: +45 46 77 10 10
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma OÜ
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 80 09 111

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España, S.A.
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Tecnimede ‑ Sociedade Técnico‑Medicinal, S.A.
Tel: +351 21 041 41 00
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba
d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
Τakeda Pharma A/S
Τηλ: +45 46 77 10 10
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 3333 000 181
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu/ .