Copalia HCT

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

amlodipine, valsartan, hydrochlorothiazide

Available from:

Novartis Europharm Limited

ATC code:

C09DX01

INN (International Name):

amlodipine, valsartan, hydrochlorothiazide

Therapeutic group:

Angiotensin II antagonists, combinations, Agents acting on the renin-angiotensin system, Angiotensin II antagonists and calcium channel blockers

Therapeutic area:

Hypertension

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.

Product summary:

Revision: 24

Authorization status:

Authorised

Authorization date:

2009-11-03

Patient Information leaflet

74
B. PACKAGE LEAFLET
75
PACKAGE LEAFLET: INFORMATION FOR THE USER
COPALIA HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS
COPALIA HCT 10 MG/160 MG/12.5 MG FILM-COATED TABLETS
COPALIA HCT 5 MG/160 MG/25 MG FILM-COATED TABLETS
COPALIA HCT 10 MG/160 MG/25 MG FILM-COATED TABLETS
COPALIA HCT 10 MG/320 MG/25 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 Copalia HCT is and what it is used for
2.
What you need to know before you take Copalia HCT
3.
How to take Copalia HCT
4.
Possible side effects
5.
How to store Copalia HCT
6.
Contents of the pack and other information
1.
WHAT COPALIA HCT IS AND WHAT IT IS USED FOR
Copalia HCT 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 increases urine output, which also lowers blood
pressure.
As a result of all three mechanisms, the blood v

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 25 mg of hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 25 mg of hydrochlorothiazide.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 320 mg of valsartan
and 25 mg of hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
White, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VCL” on the
other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VDL”
on the other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Yellow, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VEL” on the
other side. Approximate size: 15 mm