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

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

losartan (losartan potassium), hydrochlorothiazide

זמין מ:

Denk Pharma GmbH & Co. KG

קוד ATC:

C09DA01

INN (שם בינלאומי):

losartan (losartan potassium), hydrochlorothiazide

כמות:

50mg+ 12,5mg

טופס פרצבטיות:

tablets film-coated

יחידות באריזה:

(28/2x14/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2016-10-26

עלון מידע

_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 user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMA-
TION 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 mg is a combination of an angi-
otensin II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide).
CoLosar- Denk 50/12.5 is used in the treatment of essential
hypertension (high blood pressure).
If you have any questions about how CoLosar- Denk 50/12.5
works or why this medicine has been prescribed for you,
ask your doctor.
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 (hypersensitive) to losartan, hydro-
chlorothiazide or any of the other ingredients of this
medicine (listed in section 6),
•
if you are allergic (hypersensitive) to preparations
containing sulphonamide (e.g. other thiazides, some
antibiotics such as cotrimoxazole; please ask your
doctor if you are not sure),
•
if you are pregnant or breast-feeding (see also section
“Pregnancy and breast feeding”),
•
if your liver function is seriously impaired,
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מאפייני מוצר

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.
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 recommended
for patients receiving
haemodialysis. Losartan/HCT