Cozaar 50 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Losartan potassium

Disponibil de la:

IMED Healthcare Ltd.

Codul ATC:

C09CA01

INN (nume internaţional):

Losartan potassium

Dozare:

50 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

losartan

Statutul autorizaţiei:

Authorised

Data de autorizare:

2010-02-12

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 50 MG FILM-COATED TABLETS
COZAAR® 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 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 lower
high blood pressure) is no

Caracteristicilor produsului

Health Products Regulatory Authority
16 September 2022
CRN00D40K
Page 1 of 2
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 50 mg of losartan potassium.
Excipient with known effect:
Each film-coated tablet contains lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from Poland:_
White, oval film-coated tablet marked "952" on one side and scored on
the other.
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
As per PA23198/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hyprolose (E463)
Hypromellose (E464)
Lactose Monohydrate
Magnesium Stearate (E572)
Microcrystalline cellulose (E460)
Pregelatinised Maize Starch
Titanium Dioxide (E171)
Carnauba wax (E903)
Contains 4.24mg (0.108mEq) Potassium
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product on the market in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original container in order to protect from light and
moisture.
Health Products Regulatory Authority
16 September 2022
CRN00D40K
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
White opaque PVC/PE/PVDC blisters with aluminium foil lidding in an
overlabelled outer carton.
Pack of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/029/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
February 2010
10 DATE OF REVISION OF THE TEXT
September 2022