Losartan 50mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Losartan potassium

Commercializzato da:

Sandoz Ltd

Codice ATC:

C09CA01

INN (Nome Internazionale):

Losartan potassium

Dosaggio:

50mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02050502; GTIN: 5050650059021

Scheda tecnica

OBJECT 1
LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 01-Jun-2015 | Sandoz
Limited
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 (as
potassium salt).
Each Losartan Potassium 50 mg tablet contains 2.16 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets
white, oval, brake notch on both sides, embossment 3
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 Potassium may be administered with other antihypertensive
agents, especially with diuretics
(e