Edarbi Clo tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

azilsartan medoxomil, chlortalidone

Saatavilla:

Takeda Ireland Ltd.

ATC-koodi:

C09DA09

INN (Kansainvälinen yleisnimi):

azilsartan medoxomil, chlortalidone

Annos:

40mg+ 12,5mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(28/2x14/) in blister, (98/7x14/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2021-10-08

Valmisteyhteenveto

HEALTH PRODUCTS REGULATORY AUTHORITY
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how
to report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Edarbi Clo (Azilsartan medoxomil/Chlortalidone) 40 mg /12.5 mg
Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of Azilsartan medoxomil (as potassium) and
12.5 mg chlortalidone.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale red, round, (approximately 9.7 mm in diameter), biconvex,
film-coated tablet with A/C 40/12.5 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension in adults.
Azilsartan medoxomil/Chlortalidone 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.
Special populations
Older people (65 years and over)
No initial dose adjustment with Azilsartan medoxomil/Chlortalidone 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).
_______________________________________________________________________________________________________________________
_Date Printed 18/07/2018_
_CRN 2209632_
_page number: 1_
HEALTH PRODUCTS REGULATORY AUTHORITY
Renal impai