Edarbi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Azilsartan medoxomil

Available from:

Takeda Pharma A/S

ATC code:

C09CA09

INN (International Name):

azilsartan medoxomil

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Edarbi is indicated for the treatment of essential hypertension in adults.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2011-12-07

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER_ _
EDARBI 20 MG TABLETS
EDARBI 40 MG TABLETS
EDARBI 80 MG TABLETS
azilsartan medoxomil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. 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 pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN 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 EDARBI IS AND WHAT IT IS USED FOR
Edarbi contains an active substance called azilsartan medoxomil and
belongs to a class of medicines
called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is
a substance which occurs
naturally in the body and which causes the blood vessels to tighten,
therefore increasing your blood
pressure. Edarbi blocks this effect so that the blood vessels relax,
which helps lower your blood
pressure.
This medicine is used for treating high blood pressure (essential
hypertension) in adult patients (over
18 years of age).
A reduction in your blood pressure will be measureable within 2 weeks
of initiation of treatment and
the full effect of your dose will be observed by 4 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDARBI
DO NOT TAKE EDARBI IF YOU
-
are
ALLERGIC
to azilsartan medoxomil or any of the other ingredients of this
medicine (listed in
section 6).
-
are
MORE THAN 3 MONTHS PREGNANT.
(It is also better to avoid this medicine in early
pregnancy - see pregnancy section).
-
have diabetes or impaired kidney function and you are treated with a
blood pressure

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Edarbi 20 mg tablets
Edarbi 40 mg tablets
Edarbi 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Edarbi 20 mg tablets
Each tablet contains 20 mg of azilsartan medoxomil (as potassium).
Edarbi 40 mg tablets
Each tablet contains 40 mg of azilsartan medoxomil (as potassium).
Edarbi 80 mg tablets
Each tablet contains 80 mg of azilsartan medoxomil (as potassium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Edarbi 20 mg tablets
White to nearly white round tablets, 6.0 mm in diameter, debossed
“ASL” on one side and “20” on the
other.
Edarbi 40 mg tablets
White to nearly white round tablets, 7.6 mm in diameter, debossed
“ASL” on one side and “40” on the
other.
Edarbi 80 mg tablets
White to nearly white round tablets, 9.6 mm in diameter, debossed
“ASL” on one side and “80” on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Edarbi is indicated for the treatment of essential hypertension in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose in adults is 40 mg once daily. The dose
may be increased to a
maximum of 80 mg once daily for patients whose blood pressure is not
adequately controlled at the
lower dose.
Near-maximal antihypertensive effect is evident at 2 weeks, with
maximal effects attained by 4 weeks.
If blood pressure is not adequately controlled with Edarbi alone,
additional blood pressure reduction
can be achieved when this treatment is coadministered with other
antihypertensive medicinal products,
3
including diuretics (such as chlortalidone and hydrochlorothiazide)
and calcium channel blockers (see
sections 4.3, 4.4, 4.5 and 5.1).
_ _
_Special populations _
_Elderly (65 years and over) _
No initial dose adjustment with Edarbi is necessary in elderly
patients (see section 5.2), although
consideration can be given to 20 mg as a starting dose in the very
elderly (≥ 75 years), who may be at
risk of hypotension.
_