LOSARTAN MYLAN

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

LOSARTAN POTASSIUM

Tilgjengelig fra:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC-kode:

C09CA01

INN (International Name):

LOSARTAN POTASSIUM

Dosering :

100 Milligram

Legemiddelform:

Film Coated Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

losartan

Autorisasjon status:

Not Marketed

Autorisasjon dato:

2011-08-19

Informasjon til brukeren

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN MYLAN 12.5 MG FILM-COATED TABLETS
LOSARTAN MYLAN 50 MG FILM-COATED TABLETS
LOSARTAN MYLAN 100 MG FILM-COATED TABLETS
losartan potassium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or your pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Losartan Mylan is and what it is used for
2. Before you take Losartan Mylan
3. How to take Losartan Mylan
4. Possible side effects
5. How to store Losartan Mylan
6. Further information
1. WHAT LOSARTAN MYLAN IS AND WHAT IT IS USED FOR
Losartan Mylan 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 Mylan prevents the binding of
angiotensin-II to these receptors, causing the blood vessels to relax
which in turn lowers the blood
pressure. Losartan Mylan slows the decrease of kidney function in
patients with high blood pressure
and type 2 diabetes.
Losartan Mylan 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 suitabl

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Mylan 100mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Losartan Mylan 100 mg Tablet contains 100 mg of losartan
potassium.
Each Losartan Mylan 100 mg tablet contains 122.0 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, tear drop shaped, biconvex, film coated tablets debossed with
“LN100” on one side and ‘M’ on the other side.
Approximately 11.6 mm in length and 7.1 mm in width.
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 potassium. 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
For oral administration.
Losartan Mylan tablets should be swallowed whole with a glass of
water.
Losartan Mylan may be administered with or without food.
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 may be