CoLosar-Denk 50/12,5 tablets film-coated

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

losartan (losartan potassium), hydrochlorothiazide

Verfügbar ab:

Denk Pharma GmbH & Co. KG

ATC-Code:

C09DA01

INN (Internationale Bezeichnung):

losartan (losartan potassium), hydrochlorothiazide

Dosierung:

50mg+ 12,5mg

Darreichungsform:

tablets film-coated

Einheiten im Paket:

(28/2x14/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2022-05-03

Gebrauchsinformation

_CoLosar-Denk 50/12.5_
Film-coated tablet – oral use
Angiotensin II receptor antagonist and diuretic
Active substances: losartan + hydrochlorothiazide (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 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 COLOSAR-DENK 50/12.5 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE COLOSAR-DENK 50/12.5
3.
HOW TO TAKE COLOSAR-DENK 50/12.5
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE COLOSAR-DENK 50/12.5
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What CoLosar-Denk 50/12.5 is and what it is
used for
CoLosar-Denk 50/12.5 is a combination of an angiotensin II receptor
antagonist (losartan) and a diuretic (hydrochlorothiazide). The
substance angiotensin II is formed in the body and helps to regulate
the blood pressure. It binds to receptors in blood vessels, causing
them to tighten. This results in an increase in blood pressure. When
blood pressure is high, angiotensin II plays a part in maintaining
the elevated blood pressure. Losartan prevents the binding of
angiotensin II to these receptors, causing the blood vessels to relax
which in turn lowers the blood pressure.
Hydrochlorothiazide works by making the kidneys pass more water
and salt. This also helps to reduce blood pressure.
CoLosar-Denk 50/12.5 is indicated for the treatment of high blood
pressure (essential hypertension).
2.
What you need to know before you take
CoLosar-Denk 50/12.5
Do not take CoLosar-Denk 50/12.5
•
if you are allergic to losartan, hydrochlorothiazide or

Fachinformation

1
S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CoLosar-Denk 50/12.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: losartan and hydrochlorothiazide
Each film-coated tablet contains 50 mg losartan potassium equivalent
to 45.76 mg losartan and 12.5 mg
hydrochlorothiazide (HCT).
Excipient with known effect: Each film-coated tablet contains 25 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, round, biconvex, film-coated tablets, imprint
“CoLos” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CoLosar-Denk 50/12.5 is indicated for the treatment of essential
hypertension in patients whose blood
pressure cannot be adequately controlled on losartan or
hydrochlorothiazide alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Hypertension
Losartan/HCT is not suitable for use as initial treatment, but for the
treatment of patients whose blood
pressure is not adequately controlled on losartan potassium or
hydrochlorothiazide alone.
Dosage titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
Where clinically appropriate, a direct change from monotherapy to the
fixed combination may be
considered in patients whose blood pressure is not adequately
controlled.
The usual maintenance dose is one tablet of CoLosar-Denk 50/12.5 (50
mg losartan potassium and
12.5 mg HCT) once daily.
For patients who do not respond adequately, this dose may be increased
to 2 tablets of CoLosar-
Denk 50/12.5 (100 mg losartan potassium and 25 mg HCT) once daily. The
maximum dose is two
tablets of CoLosar-Denk 50/12.5 once daily.
In general, the blood pressure lowering effect is attained within
three to four weeks after the
commencement of therapy.
2
Use in patients with renal impairment and haemodialysis patients
No initial dosage adjustment is necessary in patients with moderate
renal impairment (i.e. creatinine
clearance of 30-50 ml/min). Losartan/HCT tablets are not