Co-Diovan

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

HYDROCHLOROTHIAZIDE; VALSARTAN

Dostupné z:

Novartis Pharmaceuticals UK Limited

ATC kód:

C09DA03

INN (Medzinárodný Name):

HYDROCHLOROTHIAZIDE; VALSARTAN

Forma lieku:

FILM-COATED TABLET

Zloženie:

HYDROCHLOROTHIAZIDE 25 mg; VALSARTAN 160 mg

Typ predpisu:

POM

Terapeutické oblasti:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2005-12-08

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-DIOVAN 80 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN 160 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN 160 MG/25 MG FILM-COATED TABLETS
CO-DIOVAN 320 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN 320 MG/25 MG FILM-COATED TABLETS
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 Co-Diovan is and what it is used for
2.
What you need to know before you take Co-Diovan
3.
How to take Co-Diovan
4.
Possible side effects
5.
How to store Co-Diovan
6.
Contents of the pack and other information
1.
WHAT CO-DIOVAN IS AND WHAT IT IS USED FOR
Co-Diovan film-coated tablets contain two active substances called
valsartan and hydrochlorothiazide.
Both of these substances help to control high blood pressure
(hypertension).
•
VALSARTAN
belongs to a class of medicines known as “angiotensin II receptor
antagonists”,
which help to control high blood pressure. Angiotensin II is a
substance in the body that causes
vessels to tighten, thus causing your blood pressure to increase.
Valsartan works by blocking the
effect of angiotensin II. As a result, blood vessels relax and blood
pressure is lowered.
•
HYDROCHLOROTHIAZIDE
belongs to a group of medicines called thiazide diuretics (also known
as
“water tablets”). Hydrochlorothiazide increases urine output,
which also lowers blood pressure.
Co-Diovan is used to treat high blood pressure which is not adequately
controlled by a single
substance alone.
High blood pressure increases the workload of

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Co-Diovan 80 mg/12.5 mg film-coated tablets
Co-Diovan 160 mg/12.5 mg film-coated tablets
Co-Diovan 160 mg/25 mg film-coated tablets
Co-Diovan 320 mg/12.5 mg film-coated tablets
Co-Diovan 320 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide
Each film-coated tablet contains 160 mg of valsartan and 25 mg of
hydrochlorothiazide.
Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Each film-coated tablet contains 320 mg of valsartan and 25 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
80 mg/12.5 mg: Light orange, ovaloid tablet imprinted with HGH on one
side and CG on the other
side.
160 mg/12.5 mg: Dark red, ovaloid tablet imprinted with HHH on one
side and CG on the other side.
160 mg/25 mg: Brown, ovaloid tablet imprinted with HXH on one side and
NVR on the other side.
320 mg/12.5 mg: Pink, ovaloid shaped, beveled edge tablet, imprinted
with NVR on one side and HIL
on the other side.
320 mg/25 mg: Yellow, ovaloid shaped, beveled edge tablet, imprinted
with NVR on one side and CTI
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Co-Diovan fixed-dose combination is indicated in patients whose blood
pressure is not adequately
controlled on valsartan or hydrochlorothiazide monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The recommended dose of Co-Diovan is one film-coated tablet once
daily. Dose titration with the
individual components is recommended. In each case, up-titration of
individual components to the
next dose should be followed in order to reduce the risk of
hypotension and other adverse events.
When clinically appropriate direct change from monother