CoValsar-Denk 80/12.5

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

valsartan, hydrochlorothiazide

Available from:

Denk Pharma GmbH & Co. KG

INN (International Name):

valsartan, hydrochlorothiazide

Dosage:

80mg+12,5mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

_CoValsar-Denk 80/12.5_
Film-coated tablet – oral use
Angiotensin II antagonist and diuretic
Active substances: Valsartan + Hydrochlorothia-
zide (HCT)
Package leaflet:
Information for the patient
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 of the side effects, talk to your
doctor or pharmacist. This includes any pos-
sible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. WHAT COVALSAR-DENK IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
COVALSAR-DENK
3. HOW TO TAKE COVALSAR-DENK
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE COVALSAR-DENK
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What CoValsar-Denk is
and what it is used for
CoValsar-Denk film-coated tablets contain two ac-
tive substances called valsartan and hydrochloro-
thiazide. 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 med-
icines called thiazide diuretics (also known as
“water tablets”). Hydrochlorothiazide increases
urine output, which also lowers blood pressure.
CoValsar-Denk is used to treat high blood pressure
which is not adequately controlled by a single sub-
stance alone.
High blood pressure increases the workload of the
heart and arteries. If not treated, it can da

Summary of Product characteristics

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CoValsar-Denk 80/12.5
CoValsar-Denk 160/12.5
CoValsar-Denk 320/12.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: valsartan and hydrochlorothiazide
CoValsar-Denk 80/12.5
Each tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: each 80 mg/12.5 mg film-coated tablet
contains 0.135 mg of soya leci-
thin.
CoValsar-Denk 160/12.5
Each tablet contains 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: each 160 mg/12.5 mg film-coated tablet
contains 0.270 mg of soya leci-
thin.
CoValsar-Denk 320/12.5
Each tablet contains 320 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: each 320 mg/12.5 mg film-coated tablet
contains 0.540 mg of soya leci-
thin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
CoValsar-Denk 80 mg/12.5 mg film-coated tablets are pink, biconvex and
oval-shaped.
CoValsar-Denk 160 mg/12.5 mg film-coated tablets are dark-red,
biconvex and oval-shaped.
CoValsar-Denk 320 mg/12.5 mg film-coated tablets are pink, biconvex
and oval-shaped.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
CoValsar-Denk 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
2
Posology
The recommended dose of CoValsar-Denk 80 mg/12.5 mg is one film-coated
tablet once daily. Dose
titration with the individual components is recommended. In each case,
up-titration of individual com-
ponents to the next dose should be followed in order to reduce the
risk of hypotension and other ad-
verse events.
When clinically appropriate direct change from monotherapy to the
fixed combination may be consi-
dered in patients whose blood pressure is not adequately controlled on
valsartan or hydrochlorothi-
azide monotherapy,