Lotar 50mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

losartan (losartan potassium)

Available from:

Alkaloid AD Skopje

ATC code:

C09CA01

INN (International Name):

losartan (losartan potassium)

Dosage:

50mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-12-08

Summary of Product characteristics

LOTAR

50 mg and 100 mg film-coated tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
LOTAR

50 mg film-coated tablets
LOTAR

100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lotar 50 mg film-coated tablets
Each film-coated tablet contains 50 mg losartan potassium.
Each film-coated tablet contains 35,10 mg lactose monohydrate.
Lotar 100 mg film-coated tablets
Each film-coated tablet contains 100 mg losartan potassium.
Each film-coated tablet contains 70,20 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
Film-coated tablets
Lotar 50 mg film-coated tablets
White, round, biconvex, film-coated tablets with break-mark on one
side.
Lotar 100 mg film-coated tablets
White, round, biconvex, film-coated tablets with a cross-score on one
side.
4.
CLINICAL PROPERTIES
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 (see sections 4.3, 4.4, 4.5,
and 5.1).
• Treatment of chronic heart failure in adult patients when
treatment with Angiotensin-
converting enzyme (ACE) inhibitors is not considered suitable due to
incompatibility_, _
_especially cough, _or contraindication. Patients with heart failure
who have been stabilised
LOTAR

50 mg and 100 mg film-coated tablets
Summary of Product Characteristics
2
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
Hypertens