COZAAR 50mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LOSARTAN POTASSIUM

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

C09CA01

INN (International Name):

LOSARTAN POTASSIUM 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LOSARTAN POTASSIUM 50 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2005-06-30

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET
Page 2 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR 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 c

Summary of Product characteristics

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 21
1.
NAME OF THE MEDICINAL PRODUCT
COZAAR 12.5 mg film-coated tablets
COZAAR 50 mg film-coated tablets
COZAAR 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate.
Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate.
Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
COZAAR 12.5 mg tablet
Blue, oval film-coated tablets marked 11 on one side and plain on the
other.
COZAAR 50 mg 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.
COZAAR 100 mg tablet
White, teardrop-shaped film-coated tablets marked 960 on one side and
plain on the other.
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 stroke
_ _
in adult hypertensive patients with left ventricula