Losartan Krka 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

KRKA, d.d., Novo mesto

ATC code:

C09CA; C09CA01

INN (International Name):

Losartan potassium

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; losartan

Authorization status:

Marketed

Authorization date:

2012-01-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN KRKA 25 MG FILM-COATED TABLETS
LOSARTAN KRKA 50 MG FILM-COATED TABLETS
LOSARTAN KRKA 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.
-
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Losartan Krka is and what it is used for
2.
What you need to know before you take Losartan Krka
3.
How to take Losartan Krka
4.
Possible side effects
5.
How to store Losartan Krka
6.
Contents of the pack and other information
1.
WHAT LOSARTAN KRKA 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 Krka 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-enzyme inhibitors (ACE inhibitor

Summary of Product characteristics

Health║Products║Regulatory║Authority
12║October║2021
CRN00CFPR
Page║1║of║14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan║Krka║50║mg║film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║film-coated║tablet║contains
50║mg║losartan║potassium,║equivalent║to 45.8 mg║losartan.
Excipient with known effect:║lactose║monohydrate ║
Losartan║Krka 50║mg║film-coated║tablets
Lactose║monohydrate
54.7 mg
For the║ full║list║of║excipients,║see║section 6.1.
3 PHARMACEUTICAL FORM
Film-coated║tablet
White,║round║(diameter:║7.9║–║8.2
mm),║light║biconvex,║bevel║edged,║scored║tablets.║The║score║line║is║not║intended║for║breaking║
the║tablet.
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.

Reduction║in║the║risk║of║strokein║adult║hypertensive║patients║with║left║ventricular║hypertrophy║documented║by║ECG║
(see║section║5.1║LI