Edarclor 40 mg/12,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AZILSARTANMEDOXOMIL KALIUM 42,68 mg/stuk SAMENSTELLING overeenkomend met ; AZILSARTANMEDOXOMIL 40 mg/stuk ; CHLOORTALIDON 12,5 mg/stuk

Beschikbaar vanaf:

Takeda Pharma A/S Dybendal Alle 10 2630 TAASTRUP (DENEMARKEN)

ATC-code:

C09DA09

INN (Algemene Internationale Benaming):

AZILSARTANMEDOXOMIL KALIUM 42,68 mg/stuk SAMENSTELLING overeenkomend met ; AZILSARTANMEDOXOMIL 40 mg/stuk ; CHLOORTALIDON 12,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; FUMAARZUUR (E 297) ; GRIJZE INKT ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; FUMAARZUUR (E 297) ; GRIJZE INKT ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Azilsartan medoxomil and diuretics

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); FUMAARZUUR (E 297); GRIJZE INKT; HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-11-25

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EDARCLOR 40 MG/12,5 MG, FILMOMHULDE TABLETTEN
EDARCLOR 40 MG/25 MG, FILMOMHULDE TABLETTEN
azilsartan medoxomil/chlortalidone
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 Edarclor is and what it is used for
2.
What you need to know before you take Edarclor
3.
How to take Edarclor
4.
Possible side effects
5.
How to store Edarclor
6.
Contents of the pack and other information
1.
WHAT EDARCLOR IS AND WHAT IT IS USED FOR
Edarclor contains two active substances, azilsartan medoxomil and
chlortalidone, that are used for
treating high blood pressure (hypertension) in adult patients (over 18
years of age):
-
Azilsartan medoxomil belongs to a class of medicines called
angiotensin II receptor blockers. It
lowers the blood pressure by relaxing the blood vessels.
-
Chlortalidone belongs to a class of medicines called diuretics. It
lowers the blood pressure by
helping the body to get rid of extra fluid by making your kidneys
produce more urine.
You will only be given Edarclor if treatment with azilsartan medoxomil
alone has not adequately
controlled your blood pressure. When given together, the two active
substances in Edarclor help to
lower the blood pressure more than if either of them were given alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDARCLOR
DO NOT TAKE EDARCLOR IF YOU:
-
are ALLERGIC (hypersensitive) to azilsartan medoxomil or to
chlortalidone, or any of the other
ingredients of this medicine (listed in section 6).
-
are PREGNANT. (Edarclor should

Productkenmerken

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1. NAME OF THE MEDICINAL PRODUCT
Edarclor 40 mg/12,5 mg, filmomhulde tabletten
Edarclor 40 mg/25 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Edarclor 40 mg/12.5 mg film-coated tablets:
Each tablet contains 40 mg of azilsartan medoxomil (as potassium) and
12.5 mg chlortalidone.
Edarclor 40 mg/25 mg film-coated tablets:
Each tablet contains 40 mg of azilsartan medoxomil (as potassium) and
25 mg chlortalidone.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Edarclor 40 mg/12.5 mg film-coated tablets:
Pale red, round, (approximately 9.7 mm in diameter), biconvex,
film-coated tablet with A/C 40/12.5
on one side.
Edarclor 40 mg/25 mg film-coated tablets:
Light red, round, (approximately 9.7 mm in diameter), biconvex, film
coated tablet with A/C 40/25 on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension in adults.
Edarclor is a fixed-dose combination indicated in adults whose blood
pressure is not adequately
controlled by azilsartan medoxomil monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
Adults
The recommended starting dose is 40 mg/12.5 mg once daily in patients
whose blood pressure is not
adequately controlled with current antihypertensive monotherapy such
as Edarbi 40 mg or
Edarbi 80 mg.
If needed the dose may be increased to a maximum of 40 mg/25 mg once
daily.
Near-maximal antihypertensive effect is usually evident within 1-2
weeks of dosing, with maximal
effects attained by 4 weeks.
2
Special populations
Older people (65 years and over)
No initial dose adjustment with Edarclor is necessary in elderly
patients; caution should be exercised
and close medical monitoring is recommended in the very elderly (≥
75 years), who may be at
increased risk of adverse events (see section 5.2).
Renal impairment
Chlortalidone, a component drug of Edarclor, should not be used in
patients with severe renal
impairment (GFR <30 mL/min/1.73m
2
) and anuria (see section