Losar-Denk 100 tablets film-coated

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

losartan (losartan potassium)

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG

ATC-code:

C09CA01

INN (Algemene Internationale Benaming):

losartan (losartan potassium)

Dosering:

100mg

farmaceutische vorm:

tablets film-coated

Eenheden in pakket:

(28/2x14/) in blister

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2016-11-10

Bijsluiter

_Losar-Denk 100_
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 listed in this
leaflet, please tell your doctor or pharma-
cist.
IN THIS LEAFLET:
1. WHAT LOSAR-DENK 100 IS AND
WHAT IT IS USED FOR?
2. 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. FURTHER 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 binds to
receptors in the blood vessels making them nar-
rower. This causes your blood pressure to rise.
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).
– 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 amounts of urinary pro-
tein).
– In the treatment of patients with heart failure
when your doctor believes that treatment with
ACE inhibitors (angiotensin conversion enzyme
inhibitor which is a blood pressure reducing
agent) is unsuitable. You should not be
switched to treatment with losartan if your
heart

Productkenmerken

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S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losar-Denk 100
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Losar-Denk 100 contains 100 mg losartan
potassium sal, equivalent
to 91.6 mg losartan.
Other ingredients:
Each film-coated tablet of Losar-Denk 100 contains 70 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 tablets, scored on one
side, without facet.
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 100 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 100 may be administered with other antihypertensive drugs,
such as diuretics
(hydrochlorothiazide for example).
H