Sentor tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

losartan (losartan potassium)

Disponibil de la:

Gedeon Richter PLC

Codul ATC:

C09CA01

INN (nume internaţional):

losartan (losartan potassium)

Dozare:

50mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(10/1x10/) in blister, (30/3x10/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-03-13

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SENTOR
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
_Active substances: _
Film-coated tablets, 50 mg: losartan potassium - 50 mg;
Film-coated tablets, 100 mg: losartan potassium - 100 mg.
Excipients with known effect:
_ _
_Film-coated tablets, 50 mg:_ Each film-coated tablet contains 1.050
mg of lactose monohydrate.
_Film-coated tablets, 100 mg:_ Each film-coated tablet contains 2.10
mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
_Film-coated tablets, 50 mg: _
Round, biconvex, film-coated tablets of white or almost white colour,
with break-line on one side and
engraving "50" on the other. The tablets can be divided into equal
doses.
_Film-coated tablets, 100 mg: _
Oval, biconvex, film-coated tablets of white or almost white colour,
with engraving "100" on one side,
the other side is without sign.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of essential hypertension in adults and in children and
adolescents 6-18 years of age.
-
Treatment of renal disease in adult patients with hypertension and
type 2 diabetes mellitus with
proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
-
Treatment of chronic heart failure in adult patients when treatment
with angiotensin converting
enzyme (ACE) inhibitors is not considered suitable due to intolerance,
_especially cough_, or
contraindication. Patients with heart failure who have been stabilised
with an ACE inhibitor
should not be switched to losartan. The patients should have a left
ventricular ejection fraction
≤40% and should be clinically stable and on an established treatment
regimen for chronic heart
failure.
-
Reduction in the risk of stroke in adult hypertensive patients with
left ventricular hypertrophy
documented by ECG (see section 5.1 LIFE study, Race).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypertension _
The usual starting and maintenance