Losar-Denk 25

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

INN (International Name):

losartan (losartan potassium)

Dosage:

25mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

_Losar-Denk 25_
Film-coated tablets – oral use
Angiotensin II receptor antagonist
Active ingredient: losartan potassium
PACKAGE LEAFLET:
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
– Keep this leaflet. You may need to read
it again.
– Ask your doctor or pharmacist if you
have any further questions.
– This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
– If any of the side effects gets serious,
or if you notice any side effects not list-
ed in this leaflet, please tell your doc-
tor or pharmacist.
IN THIS LEAFLET:
1. WHAT LOSAR-DENK 25 IS AND
WHAT IT IS USED FOR
2. BEFORE YOU TAKE LOSAR-DENK 25
3. HOW TO TAKE LOSAR-DENK 25
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LOSAR-DENK 25
6. FURTHER INFORMATION
1.
WHAT LOSAR-DENK 25 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 binds to receptors in the blood ves-
sels making them narrower. This causes your
blood pressure to rise. Losartan prevents
angiotensin II from binding to these recep-
tors 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 25 IS USED:
– In the treatment of patients with high
blood pressure (hypertension).
– To protect the kidneys of patients with high
blood pressure and type-2 diabetes melli-
tus along with impaired kidney function
proven by blood tests, with a urinary pro-
tein excretion of ≥ 0.5 g/day (this disease is
associated with pathologically high
amounts of urinary protein).
– In the treatment of patients with heart fail-
ure when your doctor believes that treat-
ment with ACE inhibitors (angiotensin con-
version enzyme inhibitor which is a blood
pressure reducing agent) is unsuitable. You
should not be switched to treatment with
losartan if your heart

Summary of Product characteristics

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S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losar-Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Losar-Denk 25 contains 25 mg losartan
potassium salt, equivalent
to 22.9 mg losartan.
Other ingredients:
Each film-coated tablet of Losar-Denk 25 contains 17.5 mg of lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, biconvex film-coated tablet, scored on one
side. The film-coated
tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension.
•
Treatment of renal disease in patients with hypertension and type 2
diabetes mellitus
with a proteinuria of ≥ 0.5 g/day as part of an antihypertensive
treatment.
•
Treatment of chronic heart failure in patients ≥ 60 years of age
when treatment with an
ACE inhibitor is not considered suitable due to intolerance, cough in
particular, or is
considered as contraindicated. Heart failure patients should not be
changed over to
treatment with losartan if their condition is stable with ACE
inhibitors. Patients should
have a reduced left ventricular ejection fraction ≤ 40 % and should
be clinically stable
with heart failure medication.
•
Reducing the risk of stroke in hypertonic patients with left
ventricular hypertrophy by
ECG criteria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Losartan film-coated tablets should be taken with a glass of water.
Losar-Denk 25 can be taken with or without food.
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Hypertension
The usual initial and maintenance dose for most patients is 50 mg once
a day.
The maximum reduction of blood pressure is achieved 3 to 6 weeks after
treatment is
initiated.
In some patients it may be advisable to increase the dose to 100 mg
once a day (in the
morning) in order to achieve a more optimal effect.
Losar-Denk 25 may be administered with other antihypertensive drugs,
such as diuretics
(hydrochlorothiazide for example).
Hypertension in chil