Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/5 mg/25 mg film-coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

MAH:

KRKA, d.d., Novo mesto

ATC_code:

C09DX03

INN:

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

dosage:

40/5/25 milligram(s)

pharmaceutical_form:

Film-coated tablet

therapeutic_area:

olmesartan medoxomil, amlodipine and hydrochlorothiazide

authorization_status:

Not marketed

authorization_date:

2020-10-23

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 20 MG/5
MG/12.5 MG FILM-COATED
TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/5
MG/12.5 MG FILM-COATED
TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/5 MG/25
MG FILM-COATED
TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/10
MG/12.5 MG FILM-
COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/10
MG/25 MG FILM-COATED
TABLETS
olmesartan medoxomil/amlodipine/hydrochlorothiazide
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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka is and
what it is used for
2.
What you need to know before you take Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide Krka
3.
How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA IS AND
WHAT IT IS
USED FOR
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 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 relaxing the blood
vessels.
-
Amlod

SPC

Health Products Regulatory Authority
20 December 2023
CRN00DP2Q
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/5 mg/25
mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate) and 25 mg
hydrochlorothiazide.
Excipient(s) with known effect:
Each film-coated tablet contains 14.54 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale pinkish-orange, biconvex, capsule-shaped, film-coated tablets,
engraved with a mark C2 on one side of the tablet.
Tablet dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
_ADD-ON THERAPY_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 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 Krka 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 Krka is 1 tablet per day.
_ _
_ADD-ON THERAPY_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/5 mg/25
mg may be administered in patients whose
blood pressure is not adequately controlled on Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/5
mg/12.5 mg.
A step-wise titration of the dosage of the individua