Losartan 25mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Losartan potassium

Disponible depuis:

Dexcel-Pharma Ltd

Code ATC:

C09CA01

DCI (Dénomination commune internationale):

Losartan potassium

Dosage:

25mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02050502; GTIN: 5033847001201

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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. 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.
WHAT IS IN THIS LEAFLET:
1. What Losartan Tablets are and what they are used for
2. What you need to know before you take Losartan Tablets
3. How to take Losartan Tablets
4. Possible side effects
5. How to store Losartan Tablets
6. Contents of the pack and other information
1. WHAT LOSARTAN TABLETS ARE AND WHAT THEY ARE 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 Tablets are 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 suitable by
your doctor. If your heart failure has b

Résumé des caractéristiques du produit

OBJECT 1
LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 01-Mar-2018 | Dexcel Pharma
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 (as
potassium salt).
Each Losartan potassium 25 mg Tablet contains 57.9 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Losartan potassium 25 mg Tablets are supplied as a white, film-coated,
round, biconvex tablets, scored on
both sides.
The tablet can be divided into equal halves.
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
(see sections 4.3, 4.4, 4.5 and 5.1).
• 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 increasing the dose to 100 mg once daily (in the
morning). Losartan Tablets may be
administer