Lorista H tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

losartan (losartan potassium), hydrochlorothiazide

Available from:

KRKA d.d.

ATC code:

C09DA01

INN (International Name):

losartan (losartan potassium), hydrochlorothiazide

Dosage:

50mg+ 12,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) blisters, (28/4x7/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-11

Patient Information leaflet

1.3.
I
otassium
+
H drochlorothiazide
SPC,
Labelin
and Package
Leaflet
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Summary of Product characteristics

l.3.1
otassium
+
Hydrochlorothiazide
SPC,
Labeling
and Packa
e Leaflet
1
NAME OF THE MEDICINAL PRODUCT
Lorista® H film-coated
tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
Lorista
H
film-coated
tablet
contains
50
mg
losartan,
potassium
salt,
and
J
2.5
mg
hydrochlorothiazide.
The
excipients
are stated under
item
6.1.
3
PHARMACEUTICAL FORM
Film-coated
tablets:
yellow,
oval,
slightly
biconvex
tablets
with a score
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lorista®
H
is indicated for the treatment
of essential
hypertension in patients
whose blood pressure is not
adequately controlled on losartan or hydrochlorothiazide
alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Hypertension
Losartan and hydrochlorothiazide
(HCTZ)
is not for use as initial therapy,
but
in patients whose blood
pressure
is
not adequately controlled by losartan potassium or hydrochlorothiazide
alone.
Dose titration with the individual
components
(Iosartan and hydrochlorothiazide)
is recommended.
When clinically appropriate direct
change from monotherapy to the fixed combination may be
considered in patients whose blood pressure is not adequately
controlled.
The usual maintenance dose of Lorista@ H is one tablet
of Lorista® H 50 mg112.5 mg (Iosartan
50 mg/HCTZ 12.5 mg) once daily.
For patients who do not respond adequately to Lorista® H
50 mg1l2.5 mg, the dosage may be increased to two tablets of Lorista®
H 50
_mg/12.5_
mg once daily.
The maximum dose is two tablets of Lorista® H 50 mgl12.5 mg once
daily.
In general,
the antihypertensive
effect
is attained
within
three
to four
weeks
after
initiation
ofthe,·apy.
_Use in patients_
_with renal_
_impairment_
_and haemodialysis patients_
No initial dosage adjustment
is necessary in patients with moderate renal
impainnent
(i.e.
I.:reatinine
clearance 30-50 ml/min).
Losartan and hydrochlorothiazide
tablets are not
recommended for
haemodialysis
patients.
Losartan/HCTZ tablets must
not be used in patients
with severe renal
impairment
(i.e. creatinine clearance