Losartan 50mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Losartan potassium

Հասանելի է:

Sandoz Ltd

ATC կոդը:

C09CA01

INN (Միջազգային անվանումը):

Losartan potassium

Դոզան:

50mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02050502; GTIN: 5050650059021

Ապրանքի հատկությունները

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