Losar-Denk 100 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

losartan (losartan potassium)

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C09CA01

INN (International Name):

losartan (losartan potassium)

Dosage:

100mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-08-22

Patient Information leaflet

_Losar-Denk 100_
Film-coated tablet – oral use
Angiotensin II receptor antagonist
Active substance: losartan
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
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 phar
-
macist. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1.
WHAT LOSAR-DENK 100 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSAR-DENK 100
3.
HOW TO TAKE LOSAR-DENK 100
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LOSAR-DENK 100
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Losar-Denk 100 is and what it is
used for
Losartan belongs to a class of drugs known as angiotensin II
receptor antagonists. The substance angiotensin II is formed in
your body and helps to regulate your blood pressure. It binds
to receptors in the blood vessels making them narrower. This
causes your blood pressure to rise. When blood pressure is
high, angiotensin II plays a part in maintaining the elevated
blood pressure. Losartan prevents angiotensin II from binding
to these receptors so that the blood vessels can relax and your
blood pressure drops.
Losartan slows down renal impairment in patients with high
blood pressure and type-2 diabetes.
Losar-Denk 100 is used
•
in the treatment of patients with high blood pressure
(hypertension) in adults and in children and adolescents
6 - 18 years of age.
•
to protect the kidneys of patients with high blood pressure
and type-2 diabetes mellitus along with impaired kidney
function proven by blood tests, with a urinary protein
excretion of ≥ 0.5 g/day (this disease is associated with
pathologically high

Summary of Product characteristics

1
S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losar-Denk 100
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: losartan
Each film-coated tablet contains 100 mg losartan potassium, equivalent
to 91.6 mg losartan.
Excipient with known effect: Each film-coated tablet contains 70 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, biconvex film-coated tablet with a
break-line on one side, plain on the other
side, without facet. The film-coated tablets can be divided into equal
doses.
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
(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
with an ACE-inhibitor
should not be switched to losartan. Patients should have a reduced
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 dose is 50 mg once daily for most
patients. The maximal
antihypertensive effect is attained 3 - 6 weeks after initiation of
therapy. Some patients may receive an
additional benefit by increasing the dose to 100 mg once daily (in the
morning).
Losartan may be administered with other antihypertensive agents,
especially with