Losartan 50mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Losartan potassium

Tilgjengelig fra:

Milpharm Ltd

ATC-kode:

C09CA01

INN (International Name):

Losartan potassium

Dosering :

50mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02050502; GTIN: 8901175023202

Informasjon til brukeren

Black
Pharmacode position may change as per Supplier’s m/c requirement &
additional small pharma code may appear on the front / back panel
A/s: 135 x 630 mm
PACKAGE LEAFLET: INFORMATION FOR THE
USER
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 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 is and what
it is used for
2.
What you need to know before you
take Losartan potassium
3.
How to take Losartan potassium
4.
Possible side effects
5.
How to store Losartan potassium
6.
Contents of the pack and other
information 1. WHAT LOSARTAN POTASSIUM 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 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 a

Preparatomtale

OBJECT 1
LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Losartan potassium 50 mg film-coated tablets
2. Qualitative and quantitative composition
Each Losartan potassium 50 mg tablet contains 50 mg of losartan
potassium, equivalent to 45.8 mg of
losartan.
Excipient with known effect:
Each Losartan potassium 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
patients. The maximal
antihypertensive effect is attained 3-6 weeks after initiation of
therapy. Some patients may receive an
additional benefit by i