Losartan Clonmel 100 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Losartan potassium

Διαθέσιμο από:

Clonmel Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

C09DA01

INN (Διεθνής Όνομα):

Losartan potassium

Φαρμακοτεχνική μορφή:

Film-coated tablet

Θεραπευτική περιοχή:

losartan and diuretics

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2023-01-06

Φύλλο οδηγιών χρήσης

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN CLONMEL 50 MG FILM-COATED TABLETS
LOSARTAN CLONMEL 100 MG FILM-COATED TABLETS
losartan potassium
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START GIVING 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 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 Losartan Clonmel is and what it is used for
2.
What you need to know before you give Losartan Clonmel
3.
How to take Losartan Clonmel
4.
Possible side effects
5.
How to store Losartan Clonmel
6.
Contents of the pack and other information
1.
WHAT LOSARTAN CLONMEL IS AND WHAT IT IS USED FOR
Losartan Clonmel 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.
Losartan Clonmel 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 inhibi

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
10 January 2023
CRN00CKF8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Clonmel 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg losartan potassium.
Excipient with known effect
Each film coated tablet contains 48.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round (9.3 mm in diameter) film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan Clonmel is indicated in the treatment of essential
hypertension in adults and in children and adolescents 6 - 18 years
of age.
Losartan Clonmel is indicated in the 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).
Losartan
Clonmel
is
indicated
in
the
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.
Losartan Clonmel is also indicated for 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