Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Losartan potassium

Tillgänglig från:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC-kod:

C09CA; C09CA01

INN (International namn):

Losartan potassium

Dos:

2.5 milligram(s)/millilitre

Läkemedelsform:

Powder for oral suspension

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Angiotensin II antagonists, plain; losartan

Bemyndigande status:

Not marketed

Tillstånd datum:

2009-02-27

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 2.5 MG/ML POWDER AND SOLVENT FOR ORAL SUSPENSION
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. 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 suitabl

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of powder for oral suspension delivers 500 mg of losartan
potassium. After reconstitution, each ml
suspension contains 2.5 mg of losartan potassium.
One bottle of reconstituted suspension (200 ml) contains 500 mg of
losartan potassium.
_Excipient:_
Each ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg
propylhydroxybenzoate, 50.6 mg sorbitol,
and 1.275 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for oral suspension.
White to off-white powder.
The solvent is a cloudy, colorless liquid.
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-ventricular hypertrophy documented by
ECG (see section 5.1 LIFE study, Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most
patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may
receive an additional benefit by increasing the dose to
100 mg once dail