Cozaar 50 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Organon Pharma (Ireland) Limited

ATC code:

C09CA; C09CA01

INN (International Name):

Losartan potassium

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists, plain; losartan

Authorization status:

Marketed

Authorization date:

1995-06-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 12.5MG FILM-COATED TABLETS
COZAAR® 50MG FILM-COATED TABLETS
COZAAR® 100MG 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 COZAAR is and what it is used for
2.
What you need to know before you take COZAAR
3.
How to take COZAAR
4.
Possible side effects
5.
How to store COZAAR
6.
Contents of the pack and other information
1.
WHAT COZAAR IS AND WHAT IT IS USED FOR
Losartan (COZAAR) 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.
COZAAR 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 inhibitors, medicine
used to

Summary of Product characteristics

Health║Products║Regulatory║Authority
18║May║2022
CRN00CRL7
Page║1║of║15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar║50║mg║Film-coated║Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║Cozaar║50
mg║tablet║contains║50mg║of║losartan║potassium. ║
Each║Cozaar║50 mg║tablet║contains║25.5
mg║lactose║monohydrate.
For the║full║list║of║excipients,║see║section║6.1.
3 PHARMACEUTICAL FORM
Film-coated║tablet
White,║oval║film-coated║tablets║marked║952║on║one║side║and║scored║on║the║other.
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║LIFE║study,║Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
The�