Amlodipine/Valsartan Krka 5 mg/ 80 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Amlodipine; Valsartan

Dostupné s:

KRKA, d.d., Novo mesto

ATC kód:

C10BX; C10BX09

INN (Mezinárodní Name):

Amlodipine; Valsartan

Dávkování:

5 mg/80 milligram(s)

Léková forma:

Film-coated tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

HMG CoA reductase inhibitors, other combinations; ZZZ rosuvastatin and amlodipine

Stav Autorizace:

Marketed

Datum autorizace:

2016-02-05

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN KRKA 5 MG/80 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN KRKA 5 MG/160 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN KRKA 10 MG/160 MG FILM-COATED TABLETS
amlodipine/valsartan
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 Amlodipine/Valsartan Krka is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Krka
3.
How to take Amlodipine/Valsartan Krka
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Krka
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN KRKA IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Krka tablets contain two substances called
amlodipine and valsartan. Both of
these substances help to control high blood pressure.

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.

Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing the
blood pressure. Valsartan works by blocking the effect of angiotensin
II.
This means that both of these substances help to stop the blood
vessels tightening. As a result, the
blood vessels relax and blood pressure is lowered.
Amlodipine/Valsartan Krka is used to treat high blood pressure in
adults whose blood pressure is not
controlled enough with either

Charakteristika produktu

Health Products Regulatory Authority
29 March 2023
CRN00DFMD
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Krka 5 mg/ 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg amlodipine (as amlodipine
besilate) and 80 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Brownish yellow, round, slightly biconvex, film-coated tablets with
bevel edges and with possible dark spots (tablet diameter: 8
mm, thickness 3.0 mm – 4.3 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/Valsartan Krka is indicated in adults whose blood pressure
is not adequately controlled on amlodipine or valsartan
monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of Amlodipine/Valsartan Krka is one tablet per
day.
Amlodipine/Valsartan Krka 5 mg/80 mg may be administered in patients
whose blood pressure is not adequately controlled
with amlodipine 5 mg or valsartan 80 mg alone.
Amlodipine/Valsartan Krka 5 mg/160 mg may be administered in patients
whose blood pressure is not adequately controlled
with amlodipine 5 mg or valsartan 160 mg alone.
Amlodipine/Valsartan Krka 10 mg/160 mg may be administered in patients
whose blood pressure is not adequately controlled
with amlodipine 10 mg or valsartan 160 mg alone or with
Amlodipine/Valsartan Krka 5 mg/160 mg.
Amlodipine/Valsartan Krka can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before changing to the fixed
dose combination. When clinically appropriate, direct change from
monotherapy to the fixed-dose combination may be
considered.
For convenience, patients receiving valsartan and amlodipine from
separate tablets/capsules may be switched to
Amlodipine/Valsartan Krka containing the same component doses.
_Special populations_
Renal impairment
Health Products Regulator