Losartan Potassium 50 mg Film-coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Losartan potassium

Dostupno od:

Accord Healthcare Limited

ATC koda:

C09CA; C09CA01

INN (International ime):

Losartan potassium

Doziranje:

50 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Angiotensin II antagonists, plain; losartan

Status autorizacije:

Marketed

Datum autorizacije:

2009-04-08

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS
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, 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, 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 Tablets is and what it is used for
2. What you need to know before you take Losartan Potassium Tablets
3. How to take Losartan Potassium Tablets
4. Possible side effects
5. How to store Losartan Potassium Tablets
6. Contents of the pack and other information
1. WHAT LOSARTAN POTASSIUM TABLETS 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 prevent the effect of
angiotensin-II, causing the blood vessels to
relax which in turn lowers your blood pressure. Losartan slows the
decrease of kidney function in patients
with high blood pressure and type II diabetes.
Losartan Potassium is used

to treat patient with high blood pressure (hypertension) in adults and
in children and adolescents 6-18 years
of age

to protect the kidney in hypertensive type II 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 w

Svojstava lijeka

Health Products Regulatory Authority
05 October 2018
CRN008L3R
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of losartan potassium,
equivalent to 45.8mg
of Losartan.
Excipient:
52mg of lactose/film-coated tablet.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, round, biconvex, film-coated tablets with
breakline on one side
and “50” debossing on other side.
The break line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses
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 patients with hypertension and type 2
diabetes
mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive
treatment.
·
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 stroke in hypertensive patients with left
ventricular
hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Health Products Regulatory Authority
05 October 2018
CRN008L3R
Page 2 of 24
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
HYPERTENSION
The usual starting and maintenance dose is 50 mg once daily for most
patients. The
maximal antihypertensive effect is attained 3-6 weeks after initiation
of therapy.
Some patients may receive an additional benefit by increasing the dose
to 100 mg
once daily (in the