Copalia

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

valsartan, amlodipine (as amlodipine besilate)

Dostopno od:

Novartis Europharm Limited

Koda artikla:

C09DB01

INN (mednarodno ime):

amlodipine, valsartan

Terapevtska skupina:

Agents acting on the renin-angiotensin system

Terapevtsko območje:

Hypertension

Terapevtske indikacije:

Treatment of essential hypertension. Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.,

Povzetek izdelek:

Revision: 29

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-01-15

Navodilo za uporabo

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
COPALIA 5 MG/80 MG FILM-COATED TABLETS
COPALIA 5 MG/160 MG FILM-COATED TABLETS
COPALIA 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 Copalia is and what it is used for
2.
What you need to know before you take Copalia
3.
How to take Copalia
4.
Possible side effects
5.
How to store Copalia
6.
Contents of the pack and other information
1.
WHAT COPALIA IS AND WHAT IT IS USED FOR
Copalia 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.
Copalia is used to treat high blood pressure in adults whose blood
pressure is not controlled enough
with either amlodipine or valsartan on its own.
53
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COPALIA
DO NOT TAKE COPALIA
−
if you are allergic to amlodipine or to any

Lastnosti izdelka

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Copalia 5 mg/80 mg film-coated tablets
Copalia 5 mg/160 mg film-coated tablets
Copalia 10 mg/160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Copalia 5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of valsartan.
Copalia 5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 160 mg of valsartan.
Copalia 10 mg/160 mg film-coated tablets
Each film-coated tablet contains 10 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
Copalia 5 mg/80 mg film-coated tablets
Dark yellow, round film-coated tablet with bevelled edges, imprinted
with “NVR” on one side and
“NV” on the other side. Approximate size: diameter 8.20 mm.
Copalia 5 mg/160 mg film-coated tablets
Dark yellow, oval film-coated tablet, imprinted with “NVR” on one
side and “ECE” on the other side.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
Copalia 10 mg/160 mg film-coated tablets
Light yellow, oval film-coated tablet, imprinted with “NVR” on one
side and “UIC” on the other side.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Copalia is indicated in adults whose blood pressure is not adequately
controlled on amlodipine or
valsartan monotherapy.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Copalia is one tablet per day.
Copalia 5 mg/80 mg may be administered in patients whose blood
pressure is not adequately
controlled with amlodipine 5 mg or valsartan 80 mg alone.
Copalia 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.
Copalia 10 mg/160 mg may be administered in patients whose bloo