Cozaar 100mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Losartan potassium

Disponible des:

Organon Pharma (UK) Ltd

Codi ATC:

C09CA01

Designació comuna internacional (DCI):

Losartan potassium

Dosis:

100mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02050502; GTIN: 5013945185003

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 12.5 MG FILM-COATED TABLETS
COZAAR® 25 MG FILM-COATED TABLETS
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 inhibito

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
COZAAR 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
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 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
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 daily (in the morning).
Losartan may be administered with other antihypertensive agents,
especially with
diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4, 4.5, and
5.1).
Hypertensive type II diabetic patients with proteinuria
≥
0.5