Cosartal 50 mg Film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Losartan potassium

Prieinama:

Accord Healthcare Ireland Ltd.

ATC kodas:

C09CA; C09CA01

INN (Tarptautinis Pavadinimas):

Losartan potassium

Dozė:

50 milligram(s)

Vaisto forma:

Film-coated tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Angiotensin II antagonists, plain; losartan

Autorizacija statusas:

Not marketed

Leidimo data:

2006-06-02

Pakuotės lapelis

V027
June 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSARTAL 50 MG FILM-COATED TABLETS
COSARTAL 100 MG FILM-COATED TABLETS
Losartan Potassium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or 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 COSARTAL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSARTAL
3.
HOW TO TAKE COSARTAL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE COSARTAL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT COSARTAL IS AND WHAT IT IS USED FOR
Cosartal 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. Cosartal prevents the
binding of angiotensin-II to these receptors, causing the blood
vessels to relax which in turn
lowers the blood pressure. Cosartal slows the decrease of kidney
function in patients with
high blood pressure and type 2 diabetes.
Cosartal 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 function 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 no

Prekės savybės

Health║Products║Regulatory║Authority
12║November║2018
CRN008M9J
Page║1║of║25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cosartal║50║mg║Film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║film-coated║tablet║contains║50
mg║of║losartan║potassium
For║a║full║list║of║excipients,║see║Section║6.1║
3 PHARMACEUTICAL FORM
Film-coated║tablet.║
White,║round,║biconvex,║scored,║film-coated║tablet,║marked║3L║on║one║side.║
The║tablet║can║be║divided║into║equal║halves.║
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cosartal║is║indicated║for║the:
–
║Treatment║of║essential║hypertension║in║adults║and║in║children║and║adolescents║6-18
years║of║age.
–
║Treatment║of║renal║disease║in║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�