Cozatan 50 mg Film-coated Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Losartan potassium

Commercializzato da:

Clonmel Healthcare Ltd

Codice ATC:

C09CA; C09CA01

INN (Nome Internazionale):

Losartan potassium

Dosaggio:

50 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Angiotensin II antagonists, plain; losartan

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2007-09-14

Foglio illustrativo

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
COZATAN 50MG FILM-COATED TABLETS
COZATAN 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 or your pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cozatan is and what it is used for
2. What you need to know before you take Cozatan
3. How to take Cozatan
4. Possible side effects
5. How to store Cozatan
6. Contents of the pack and other information
1. WHAT COZATAN IS AND WHAT IT IS USED FOR
Losartan 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.
Cozatan 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 suita

Scheda tecnica

Health Products Regulatory Authority
12 November 2019
CRN009966
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozatan 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cozatan 50 mg tablet contains 50 mg of losartan (as potassium
salt).
Excipient with known effect:
Each Cozatan 50 mg tablet contains 115.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White round biconvex film-coated tablet with cross-score breaking
notch on both sides. The tablet can be divided into equal
doses.
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.
· Treatment of chronic heart failure (in patients ≥ 60 years), when
treatment with 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
stabilised under the treatment of the 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).
Cozatan may be administered with other antihypertensive agents (see
sections 4.3, 4.4, 4.5 and 5.1), especially with diuretics
(e.g. hydrochlorothiazide).
Paediatric populati