Myzaar 50 mg film-coated tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Losartan potassium

Доступна с:

McDermott Laboratories Ltd., T/A Gerard Laboratories

код АТС:

C09CA; C09CA01

ИНН (Международная Имя):

Losartan potassium

дозировка:

50 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Angiotensin II antagonists, plain; losartan

Статус Авторизация:

Not marketed

Дата Авторизация:

2008-01-25

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYZAAR 50 MG FILM-COATED TABLETS
MYZAAR 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 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 of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Myzaar is and what it is used for
2. What you need to know before you take Myzaar
3. How to take Myzaar
4. Possible side effects
5. How to store Myzaar
6. Contents of the pack and other information.
1.
WHAT MYZAAR IS AND WHAT IT IS USED FOR
Myzaar contains the active substance losartan, which 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
those receptors, causing
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.
Myzaar are 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, medicines
used to lower
high bl

Характеристики продукта

Health Products Regulatory Authority
02 August 2023
CRN00DLMW
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Myzaar 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of losartan (as potassium
salt).
Excipient with known effect:
Each film-coated tablet contains 25.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white film_-_coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of essential hypertensionin 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 patie