Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/12.5 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Amlodipine; Valsartan; Hydrochlorothiazide

Tillgänglig från:

KRKA, d.d., Novo mesto

ATC-kod:

C09DX01

INN (International namn):

Amlodipine; Valsartan; Hydrochlorothiazide

Dos:

5/160/12.5 milligram(s)

Läkemedelsform:

Film-coated tablet

Terapiområde:

valsartan, amlodipine and hydrochlorothiazide

Bemyndigande status:

Marketed

Tillstånd datum:

2020-10-16

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 5 MG/160 MG/12.5 MG
FILM-COATED TABLETS
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 5 MG/160 MG/25 MG
FILM-COATED TABLETS
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 10 MG/160 MG/12.5 MG
FILM-COATED TABLETS
amlodipine/valsartan/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 Amlodipine/Valsartan/Hydrochlorothiazide Krka is and what it is
used for
2.
What you need to know before you take
Amlodipine/Valsartan/Hydrochlorothiazide Krka
3.
How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka
4.
Possible side effects
5.
How to store Amlodipine/Valsartan/Hydrochlorothiazide Krka
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS
USED FOR
Amlodipine/Valsartan/Hydrochlorothiazide Krka tablets contain three
substances called amlodipine,
valsartan and hydrochlorothiazide.
All 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.
-
Hydrochlorothiazide belongs to a gro

Produktens egenskaper

Health Products Regulatory Authority
14 December 2023
CRN00DPCL
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/12.5 mg
film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg amlodipine (as amlodipine
besilate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White or almost white, oval, biconvex, film-coated tablets, engraved
with mark K1 on one side of the tablet, dimensions
approximately 13 x 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is adequately controlled on
the combination of amlodipine, valsartan and hydrochlorothiazide
(HCT), taken either as three single-component formulations
or as a dual-component and a single-component formulation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka
is one tablet per day, to be taken preferably in the
morning.
Before switching to Amlodipine/Valsartan/Hydrochlorothiazide Krka
patients should be controlled on stable doses of the
monocomponents taken at the same time. The dose of
Amlodipine/Valsartan/Hydrochlorothiazide Krka should be based on
the doses of the individual components of the combination at the time
of switching.
The maximum recommended dose of
Amlodipine/Valsartan/Hydrochlorothiazide Krka is 10 mg/320 mg/25 mg.
Special populations
_Renal impairment _
Due to the hydrochlorothiazide component,
Amlodipine/Valsartan/Hydrochlorothiazide Krka is contraindicated for
use in
patients with anuria (see section 4.3) and in patients with severe
renal impairment (glomerular filtration rate (GFR) <30
ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
No adjustment of the initial dose is required for patients with mild
to moderate renal impairment (see secti