Amlodipine/Valsartan Krka 10 mg / 320 mg film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Amlodipine; Valsartan

Prieinama:

KRKA, d.d., Novo mesto

ATC kodas:

C09DB01

INN (Tarptautinis Pavadinimas):

Amlodipine; Valsartan

Dozė:

10 mg/320 milligram(s)

Vaisto forma:

Film-coated tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

valsartan and amlodipine

Autorizacija statusas:

Not marketed

Leidimo data:

2016-02-05

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN KRKA 5 MG/320 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN KRKA 10 MG/320 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 is used to treat high blood pressure in
patients who are already taking
amlodipine and valsartan at these doses, instead of taking the two
medicines separately.
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.
2

Prekės savybės

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 10 mg / 320 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg amlodipine (as amlodipine
besilate) and 320 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Brownish yellow, biconvex, capsule shaped film-coated tablets with
possible dark spots (tablet dimesion: 16 mm x 8.5 mm,
thickness: 5.8 mm – 7.8 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amlodipine/Valsartan Krka is indicated as substitution therapy for
treatment of essential hypertension in patients already
controlled with valsartan and amlodipine given concurrently at the
same dose level as in the combination.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of Amlodipine/Valsartan Krka is one tablet per
day.
Amlodipine/Valsartan Krka can be used with or without food.
The fixed dose combination is not suitable for initial therapy.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before changing to the fixed dose
combination.
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
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 Krka is contraindicated in patients with severe
hepatic impairment (see section 4.3).
Caution should be exercised when administering Amlodipine/Valsartan
Krka to patients with hepatic impairment or biliary
obstructive disorders (see section 4.4). In patients with mild to
moderate hep