AMLODIPINE/VALSARTAN TEVA 10/160 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN, AMLODIPINE BESILATE

Available from:

Teva B.V.

ATC code:

C09DB01

INN (International Name):

VALSARTAN, AMLODIPINE BESILATE

Dosage:

10/160 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and calcium channel blockers

Authorization status:

Authorised

Authorization date:

2016-09-16

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Teva 10 mg/160 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate) and 160 mg of valsartan.
Excipient with known effect:
Each 10 mg/160 mg film-coated tablet contains 5.4 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Amlodipine/Valsartan Teva 10 mg/160 mg are oval, yellow, film-coated
tablets with bevelled edges, ~14.5 mm x
7.5mm, with debossing 10 and 160 divided with break line.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/Valsartan Teva 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 Teva is one tablet per
day.
Amlodipine/Valsartan Teva 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 Teva 5 mg/160 mg.
Amlodipine/Valsartan Teva 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 Teva 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.
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