Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 40 mg/5 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C09DX03

INN (International Name):

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Dosage:

40 mg/5 mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

olmesartan medoxomil, amlodipine and hydrochlorothiazide

Authorization status:

Marketed

Authorization date:

2021-01-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 20 MG/5
MG/12.5 MG FILM COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/5
MG/12.5 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/10
MG/12.5 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/5
MG/25 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD 40 MG/10
MG/25 MG
FILM-COATED TABLETS
olmesartan medoxomil/amlodipine/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is and
what it is
used for
2.
What you need to know before you take Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide Accord
3.
How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide
Accord
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE ACCORD IS AND
WHAT IT
IS USED FOR
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord contains
three active substances
called olmesartan medoxomil, amlodipine (as amlodipine besilate) and
hydrochlorothiazide. All
three substances help to control high blood pressure.
•
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II receptor
antagonists”, which lowers blood pressure by relax

Summary of Product characteristics

Health Products Regulatory Authority
12 June 2023
CRN00DF4K
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 40 mg/5
mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 40 mg olmesartan medoxomil, 5 mg
amlodipine (as besilate) and 12.5 mg
hydrochlorothiazide.
Excipient with known effect:
Each film‑coated tablet contains 14.25 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Light yellow, approximate 9.50 mm in diameter, round, bevel-edged,
film-coated tablets debossed with "OC2" on one side and
plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
_ _
_Add-on therapy_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is
indicated in adult patients whose blood pressure is not
adequately controlled on the combination of olmesartan medoxomil and
amlodipine taken as dual-component formulation.
_Substitution therapy_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord is
indicated as substitution therapy in adult patients whose
blood pressure is adequately controlled on the combination of
olmesartan medoxomil, amlodipine and hydrochlorothiazide,
taken as a dual-component (olmesartan medoxomil and amlodipine or
olmesartan medoxomil and hydrochlorothiazide) and a
single-component formulation (hydrochlorothiazide or amlodipine).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS_
The recommended dose of Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide Accord is 1 tablet per day.
_ _
_Add-on therapy_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord 40 mg/5
mg/12.5 mg may be administered in patients whose
blood pressure is not adequately controlled on olmesartan medoxomil 40
mg and amlodipine 5 mg taken as dual-component
combination or in patients whose blood pressure is not adequately
controlled on Olmesartan
medox