Cozaar 100mg Film-Coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Losartan potassium

Доступна з:

Imbat Limited

Код атс:

C09CA; C09CA01

ІПН (Міжнародна Ім'я):

Losartan potassium

Дозування:

100 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Angiotensin II antagonists, plain; losartan

Статус Авторизація:

Authorised

Дата Авторизація:

2008-02-22

інформаційний буклет

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 lower high blood
pressure) is not considered suitable

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar 100mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 91.6mg losartan as 100mg losartan potassium.
Excipients: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the United Kingdom, Italy and the Czech
Republic:_
White, teardrop-shaped, film-coated tablet marked ‘960’ on one
side and plain on the reverse.
4 CLINICAL PARTICULARS
As per PA1286/004/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/004/003
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
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light and
moisture.
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6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips. Pack size 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
W