Olmesartan/Amlodipine Krka 20 mg/5 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Olmesartan medoxomil; Amlodipine besilate

Disponibil de la:

KRKA, d.d., Novo mesto

Codul ATC:

C09DB; C09DB02

INN (nume internaţional):

Olmesartan medoxomil; Amlodipine besilate

Dozare:

20 mg/5 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine

Statutul autorizaţiei:

Marketed

Data de autorizare:

2017-08-18

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN/AMLODIPINE KRKA 20 MG/5 MG FILM-COATED TABLETS
OLMESARTAN/AMLODIPINE KRKA 40 MG/5 MG FILM-COATED TABLETS
OLMESARTAN/AMLODIPINE KRKA 40 MG/10 MG FILM-COATED TABLETS
Olmesartan medoxomil/Amlodipine
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/Amlodipine Krka is and what it is used for
2.
What you need to know before you take Olmesartan/Amlodipine Krka
3.
How to take Olmesartan/Amlodipine Krka
4.
Possible side effects
5.
How to store Olmesartan/Amlodipine Krka
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR
Olmesartan/Amlodipine Krka contains two substances called olmesartan
medoxomil and amlodipine
(as amlodipine besilate). Both of these substances help to control
high blood pressure.
-
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin II receptor
antagonists” which lower blood pressure by relaxing the blood
vessels.
-
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
stops calcium from moving into the blood vessel wall which stops the
blood vessels from
tightening thereby also reducing blood pressure.
-
The actions of both these substances contribute to stopping the
tightening of blood vessels, so that
blood vessels relax and blood pressure decreases.
Olmesartan/Amlodipine Krka is used for the treatment of high blood
pressure in patients whose blood
pressure is not controlled enough with either olme

Caracteristicilor produsului

Health Products Regulatory Authority
19 August 2022
CRN00D0Q7
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan/Amlodipine Krka 20 mg/5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil and 5 mg
amlodipine (as amlodipine besilate).
Excipient(s) with known effect:
Each film-coated tablet contains 4.20 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
White or almost white, round, biconvex, film-coated tablets with
bevelled edges. Tablet dimension: diameter: 7 mm, thickness:
2.5 – 4.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan/Amlodipine Krka is indicated in adult patients whose blood
pressure is not adequately controlled on olmesartan
medoxomil or amlodipine monotherapy (see section 4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dosage of Olmesartan/Amlodipine Krka is 1 tablet per
day.
Olmesartan/Amlodipine Krka 20 mg/5 mg may be administered in patients
whose blood pressure is not adequately controlled
by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.
Olmesartan/Amlodipine Krka 40 mg/5 mg may be administered in patients
whose blood pressure is not adequately controlled
by Olmesartan/Amlodipine Krka 20 mg/5 mg.
Olmesartan/Amlodipine Krka 40 mg/10 mg may be administered in patients
whose blood pressure is not adequately controlled
by Olmesartan/Amlodipine Krka 40 mg/5 mg.
A step-wise titration of the dosage of the individual components is
recommended before changing to the fixed combination.
When clinically appropriate, direct change from monotherapy to the
fixed combination may be considered.
For convenience, patients receiving olmesartan medoxomil and
amlodipine from separate tablets may be switched to
Olmesartan/Amlodipine Krka tablets containing the same component
doses.
Olmesartan/Amlodipine Krka can be taken with