Losar-Denk 25 tablets film-coated

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

losartan (losartan potassium)

Tillgänglig från:

Denk Pharma GmbH & Co. KG

ATC-kod:

C09CA01

INN (International namn):

losartan (losartan potassium)

Dos:

25mg

Läkemedelsform:

tablets film-coated

Enheter i paketet:

(28/2x14/) blisters

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2018-12-05

Bipacksedel

_ Losar-Denk 25_
Film-coated tablets – oral use
Angiotensin II receptor antagonist
Active ingredient:
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 25 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW 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.
CONTENTS OF THE PACK AND OTHER 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 vessels
making them narrower. 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 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 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 protein)
•
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

Produktens egenskaper

1
SUMMARY
OF
PRODUCT
CHARACERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losar-Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: losartan
Each film-coated tablet contains 25 mg losartan potassium, equivalent
to 22.9 mg losartan.
Excipient with known effect: Each film-coated tablet contains 17.5 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 and plain on the
other side.
The film-coated tablet can be divided into equal doses.
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
POSOLOGY
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).
Hypertensive patients with type 2 diabetes mellitus and a proteinuria
≥ 0.5 g/day
The usual initial dose is 50