LOSARTAN POTASSIUM MILPHARM 50 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOSARTAN POTASSIUM

Available from:

Milpharm Limited

ATC code:

C09CA01

INN (International Name):

LOSARTAN POTASSIUM

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain

Authorization status:

Authorised

Authorization date:

2014-11-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM MILPHARM 50 MG FILM-COATED TABLETS
 LOSARTAN POTASSIUM MILPHARM 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
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 or 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 Milpharm is and what it is used for 
2.  What you need to know before you take Losartan
potassium Milpharm 
3.  How to take Losartan potassium Milpharm 
4.  Possible side effects 
5.  How to store Losartan potassium Milpharm 
6.  Contents of the pack and other information

1.  WHAT LOSARTAN POTASSIUM MILPHARM 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-2 diabetes.
Losartan potassium Milpharm 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 abnorma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan potassium Milpharm 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Losartan potassium Milpharm 50 mg tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of
losartan.
Excipient with known effect:
Each Losartan potassium Milpharm 50 mg tablet contains 40 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘4’  and ‘6’ separated
by score line on the other side. The tablet can be divided into equal doses. The size is 10.3 mm x 5.4 mm.
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.
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