Lorista HD 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:

100mg+ 25mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-01

Summary of Product characteristics

1.3.1
Losartan potassium + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
SI
SmPCPIL118955_2
13.11.2018 – Updated: 29.04.2019
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Lorista HD 100 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lorista HD 100 mg/25 mg film-coated tablets
Each film-coated tablet contains 100 mg losartan potassium and 25 mg
hydrochlorothiazide.
Excipients with known effect: Lactose monohydrate, Quinoline Yellow
(E104).
Each tablet contains:
Lorista HD
100 mg/25 mg
Lactose
119.95 mg
Quinoline
Yellow (E104)
0.11 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval, slightly biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lorista HD 100 mg/25 mg 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
Hypertension
The combination of losartan and hydrochlorothiazide (HCTZ) is not for
use as initial therapy, but in
patients whose blood pressure is not adequately controlled by losartan
or hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When 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 of Lorista H is one tablet of Lorista H 50
mg/12.5 mg (losartan 50 mg/HCTZ
12.5 mg) once daily. For patients who do not respond adequately to
Lorista H 50 mg/12.5 mg, the dosage
may be increased to one tablet of Lorista HD 100 mg/25 mg (losartan
100 mg/ HCTZ 25 mg) once daily.
CONFIDENTIAL
Lorista HD film-coated tablet 100 mg/25 mg
VOL: 1; P: 12 / 57
1.3.1
Losartan potassium + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
SI
SmPCPIL118955_2
13.11.2018 – Updated: 29.04.2019
Page 2 of 19
The maximum dose is one tablet of Lorista HD 100 mg/