Losartan Potassium 100mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LOSARTAN POTASSIUM

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

C09CA01

INN (International Name):

LOSARTAN POTASSIUM 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LOSARTAN POTASSIUM 100 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2011-04-25

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS
LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS LOSARTAN POTASSIUM 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, 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 Losartan Potassium Tablets is and what it is used for
2. What you need to know before you take Losartan Potassium Tablets
3. How to take Losartan Potassium Tablets
4. Possible side effects
5. How to store Losartan Potassium Tablets
6. Contents of the pack and other information
1. WHAT LOSARTAN POTASSIUM TABLETS 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 II diabetes.
Losartan Potassium 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 II 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
chr

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losartan Potassium 100 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100mg of losartan potassium,
equivalent to 91.7mg of Losartan.
Excipient:
104mg of lactose/film-coated tablet.
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off white, round, biconvex, film-coated tablets plain on one
side and “100” debossing on
other side.
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 (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 Potassium Tablets may be administered with other
antihypertensive agents, especially with
diuretics (e.g. hydrochlorothiazide, see sections 4.5 and 5.1).
HYPERTENSIVE TYPE