Cozaar 50 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Imbat Limited

ATC code:

C09CA; C09CA01

INN (International Name):

Losartan potassium

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; losartan

Authorization status:

Authorised

Authorization date:

2004-07-30

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR
® 50MG FILM-COATED TABLETS
(losartan potassium)
Your medicine is available using the name Cozaar 50mg Film-
Coated Tablets but will be referred to as Cozaar throughout this
leaflet.
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 ≥ 0.5g 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 ang

Summary of Product characteristics

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 (equivalent to 45.8mg
losartan).
Excipients: Lactose Monohydrate
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Italy, UK and Spain:_
White, oval-shaped, film-coated tablet marked '952'
on one side and a single score line on the other.
4 CLINICAL PARTICULARS
As per PA1286/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Italy and the UK:_
Hyprolose
Hypromellose
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Pregelatinised starch
Titanium dioxide (E171)
Carnauba wax
_Product imported from Spain:_
Microcrystalline cellulose (E460)
Lactose monohydrate
Pregelatinised maize starch
Magnesium stearate (E572)
Hyprolose (E463)
Hypromellose (E464)
Carnauba wax (E903)
Titanium dioxide (E171)
‘Cozaar’ 50 mg also contains 4.24 mg (0.108mEq) of potassium.
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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