LOSARTAN POTASSIUM MSD 12.5 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LOSARTAN POTASSIUM

Commercializzato da:

Merck Sharp & Dohme Ireland (Human Health) Limited

Codice ATC:

C09CA01

INN (Nome Internazionale):

LOSARTAN POTASSIUM

Dosaggio:

12.5 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Angiotensin II antagonists, plain

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-04-23

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 12.5MG FILM-COATED TABLETS
COZAAR® 50MG FILM-COATED TABLETS
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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium MSD 12.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Losartan Potassium MSD 12.5 mg tablet contains 12.5 mg of
losartan potassium.
Each Losartan Potassium MSD 12.5 mg tablet contains 25.25 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue, oval film-coated tablets marked 11 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 g/day
T