Losartan Potassium 100mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LOSARTAN POTASSIUM

Available from:

Accord Healthcare Limited

ATC code:

C09CA01

INN (International Name):

LOSARTAN POTASSIUM

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LOSARTAN POTASSIUM 100 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2011-04-25

Patient Information leaflet

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 prevent the effect of
angiotensin-II, causing the blood vessels to
relax which in turn lowers your 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 patient 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 chronic heart failure when therapy w

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  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 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  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  maxim