Lopress 50mg film-coated tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

LOSARTAN POTASSIUM

Dostupno od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC koda:

C09CA01

INN (International ime):

LOSARTAN POTASSIUM 50 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

LOSARTAN POTASSIUM 50 mg

Tip recepta:

POM

Područje terapije:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status autorizacije:

Withdrawn

Datum autorizacije:

2006-12-05

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPRESS
50 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 Lopress is and what it is used for
2.
What you need to know before you take Lopress
3.
How to take Lopress
4.
Possible side effects
5.
How to store Lopress
6.
Contents of the pack and other information
1.
WHAT LOPRESS IS AND WHAT IT IS USED FOR
Lopress 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 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.
Lopress 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 s

Svojstava lijeka

1.
NAME OF THE MEDICINAL PRODUCT
Lopress 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lopress 50 mg film-coated tablet contains 50 mg of losartan (as
potassium salt).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, scored, diameter 10mm, film-coated tablets
marked 3L on one side.
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 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 heart failure.
-
Reduction in the risk of stroke in 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).
Lopress may be administered with other antihypertensive agents,
especially with diuretics
(e.g. hydrochlorothiazide). (see sections 4.3, 4.4, 4.5 and 5.1).
_Paediatric population _
There are limited data on the efficacy and safety of losartan in
children and adolescents aged
6-18 years old for the treatment of hypertension (see section 5.1).
Limited pharmacokinetic
data are