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

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Amlodipine; Valsartan

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

C09DB; C09DB01

INN (International Name):

Amlodipine; Valsartan

Dosering :

5mg/160 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists and calcium channel blockers; valsartan and amlodipine

Autorisasjon status:

Not marketed

Autorisasjon dato:

2016-09-02

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN ROWEX 5MG/80MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN ROWEX 5MG/160MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN ROWEX 10MG/160MG FILM-COATED TABLETS
Amlodipine (as amlodipine besylate) /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 Rowex is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Rowex
3.
How to take Amlodipine/Valsartan Rowex
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Rowex
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN ROWEX IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Rowex 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 Rowex is used to treat high blood pressure in
adults whose blood pressure is not

Preparatomtale

Health Products Regulatory Authority
04 October 2022
CRN00D0SF
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Rowex 5 mg/160 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 160 mg of valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Dark yellow, ovaloid film-coated tablet with beveled edges, debossed
with “NVR” on one side and “ECE” on the other side.
Dimension: approximately 14.2 mm x 5.7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/Valsartan Rowex 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 Rowex is one tablet per
day.
Amlodipine/Valsartan Rowex 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 Rowex 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 Rowex containing the same component doses.
_ _
_Renal impairment_
There are no available clinical data in severely renally impaired
patients. No dosage adjustment is required for patients with
mild to moderate renal impairment. Monitoring of potassium levels and
creatinine is advised in moderate renal impairment.
_Hepatic impairment_
Amlodipine/Valsartan Rowex is contraindicated in patients with severe
hepatic impairment (see section 4.3).
Caution should be exercised wh