Cozaar 50 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Losartan potassium

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

C09CA; C09CA01

INN (Международно Name):

Losartan potassium

дозиране:

50 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Angiotensin II antagonists, plain; losartan

Статус Оторизация:

Authorised

Дата Оторизация:

2004-02-06

Листовка

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

Данни за продукта

Health Products Regulatory Authority
15 June 2022
CRN00CZFF
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 tablet contains 50 mg losartan potassium.
Excipient with known effect
Lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the Netherlands, Spain, Poland._
White, oval-shaped, film-coated tablet marked '952' on one side and a
single score line on the other.
4 CLINICAL PARTICULARS
As per PA23198/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
List of excipients
Hyprolose
Hypromellose
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Pregelatinised starch
Titanium dioxide
Carnauba wax
COZAAR 50 mg film coated Tablets also contain 4.24 mg (0.108 mEq)
potassium
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
Health Products Regulatory Authority
15 June 2022
CRN00CZFF
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Store in the original package in order to protect from light and
moisture
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 or 30 film-coated tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/106/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
February 2004
Date of last renewal: 6
th
February 2009
10 DATE OF REVISION OF THE TEXT
June 2022