Losartan potassium 50 mg film-coated tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

LOSARTAN POTASSIUM

Dostupné z:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC kód:

C09CA01

INN (Medzinárodný Name):

LOSARTAN POTASSIUM 50 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

LOSARTAN POTASSIUM 50 mg

Typ predpisu:

POM

Terapeutické oblasti:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2014-10-10

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS
LOSARTAN POTASSIUM 100 MG FILM-COATED TABLETS
losartan potassium
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 or
nurse.
-
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 pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Losartan potassium is and what it is used for
2.
What you need to know before you take Losartan potassium
3.
How to take Losartan potassium
4.
Possible side effects
5.
How to store Losartan potassium
6.
Contents of the pack and other information
1.
WHAT LOSARTAN POTASSIUM IS AND WHAT IT IS USED FOR
Losartan belongs to a group of medicines known as angiotensin-II
receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to
receptors in blood vessels,
causing them to tighten. This results in an increase in blood
pressure. Losartan prevents the binding
of angiotensin-II to these receptors, causing the blood vessels to
relax which in turn lowers the
blood pressure. Losartan slows the decrease of kidney function in
patients with high blood pressure
and type-2 diabetes.
Losartan potassium is used
•
to
treat
patients
with
high
blood
pressure
(hypertension)
in
adults
and
in
children
and
adolescents 6-18 years of age.
•
to protect the kidney in hypertensive type 2 diabetic patients with
laboratory evidence of
impaired renal function and proteinuria ≥ 0.5 g per day (a condition
in which urine contains an
abnormal amount of protein).
•
to treat patients with
chronic heart failure when therapy with specific medicines
called
angiotensin-converting-

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losartan potassium 50 mg film-coated tablets
Losartan potassium 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Losartan potassium 50 mg tablet contains 50 mg of losartan
potassium, equivalent to 45.8 mg
of losartan.
Each Losartan potassium 100 mg tablet contains 100 mg of losartan
potassium, equivalent to 91.7 mg
of losartan.
Excipient with known effect:
Each Losartan potassium 50 mg tablet contains 40 mg lactose
monohydrate.
Each Losartan potassium 100 mg tablet contains 80 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Losartan potassium 50 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed
with ‘E’ on one side and ‘4’
and ‘6’ separated by score line on the other side. The tablet can
be divided into equal doses. The size
is 10.3 mm x 5.4 mm.
Losartan potassium 100 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed
with ‘E’ on one side and ‘47’
on other side. The size is 13.1 mm x 6.9 mm.
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. 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.
•