Losartan 25mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Losartan potassium

Beszerezhető a:

Milpharm Ltd

ATC-kód:

C09CA01

INN (nemzetközi neve):

Losartan potassium

Adagolás:

25mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02050502; GTIN: 8901175023196

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM 25 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 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

Termékjellemzők

OBJECT 1
LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Losartan potassium 25 mg film-coated tablets
2. Qualitative and quantitative composition
Each Losartan potassium 25 mg tablet contains 25 mg of losartan
potassium, equivalent to 22.9 mg of
losartan.
Excipient with known effect:
Each Losartan potassium 25 mg tablet contains 20 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 '5' and '7' on either side of
scoreline on one side and 'J' with a scoreline on other side. The
tablet can be divided into equal doses. The
size is 8.1 mm x 4.1 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
addit