Amlodipine/Valsartan/Hydrochlorothiazide Rowex 5 mg/160 mg/12.5 mg Film-coated tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Amlodipine besilate; Valsartan; Hydrochlorothiazide

Доступно од:

Rowex Ltd

АТЦ код:

C09DX; C09DX01

INN (Међународно име):

Amlodipine besilate; Valsartan; Hydrochlorothiazide

Дозирање:

5/160/12.5 milligram(s)

Фармацеутски облик:

Film-coated tablet

Терапеутска област:

Angiotensin II antagonists, other combinations; valsartan, amlodipine and hydrochlorothiazide

Статус ауторизације:

Not marketed

Датум одобрења:

2019-08-19

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX 5 MG/160 MG/12.5 MG
FILM-COATED TABLETS
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX 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 Rowex is and what it is
used for
2.
What you need to know before you take
Amlodipine/Valsartan/Hydrochlorothiazide Rowex
3.
How to take Amlodipine/Valsartan/Hydrochlorothiazide Rowex
4.
Possible side effects
5.
How to store Amlodipine/Valsartan/Hydrochlorothiazide Rowex
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX IS AND WHAT IT IS
USED FOR
Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 group of substances called
“thiazide diuretics”. Hydrochlorothiazide
inc

Карактеристике производа

Health Products Regulatory Authority
07 September 2022
CRN00D0TX
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan/Hydrochlorothiazide Rowex 5 mg/160 mg/12.5 mg
Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, ovaloid, biconvex tablets with bevelled edge, debossed "NVR" on
one side and "VCL" on the other side.
Length: approx. 15 mm
Width: approx. 5.9 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 Rowex
is one tablet per day, to be taken preferably in
the morning.
Before switching to Amlodipine/Valsartan/Hydrochlorothiazide Rowex
patients should be controlled on stable doses of the
monocomponents taken at the same time. The dose of
Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 Rowex is 10 mg/320 mg/25 mg.
_Special populations_
_Renal impairment_
Due to the hydrochlorothiazide component,
Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 m
2
) (see sections 4.3, 4.4 and 5.2).
No adjustment of the initial dose is required for patients with mild
to moderate renal impairm