Lorista H

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

losartan (losartan potassium), hydrochlorothiazide

Доступна с:

KRKA d.d.

ИНН (Международная Имя):

losartan (losartan potassium), hydrochlorothiazide

дозировка:

50mg+12,5mg

Фармацевтическая форма:

tablets film-coated

Тип рецепта:

Prescription

Характеристики продукта

1.3.1
Losartan potassium + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
AM
SmPCPIL050468_1
13.05.2014 – Updated: 13.05.2014
Page 1 of 9
1
NAME OF THE MEDICINAL PRODUCT
Lorista
®
H film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lorista H film-coated tablet contains 50 mg losartan, potassium
salt, and 12.5 mg
hydrochlorothiazide.
The excipients are stated under item 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets: yellow, oval, slightly biconvex tablets with a
score on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arterial hypertension when combined treatment is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual initial and maintenance dose is one Lorista H tablet once
daily. If no adequate
response is achieved, the dosage can be increased to 2 Lorista H
tablets. Dosage should be
adjusted according to the blood pressure reduction achieved in 3 weeks
of treatment. The
maximum recommended daily dose is 2 Lorista H tablets once daily.
_Dosage in renal impairment: _
Patients with mild renal impairment (creatinine clearance more than
0.5 ml/s and/or 30
ml/min) may be given the usual dose of Lorista H. Lorista H is not
recommended in patients
with severe renal impairment and in patients on hemodialysis.
The recommended initial dose of losartan for patients with hypovolemia
is 25 mg once daily
therefore treatment with Lorista H should not be initiated before
treatment with diuretics is
discontinued and hypovolemia improved.
Lorista H is not recommended for treatment of patients with hepatic
impairment.
Patients can take Lorista H with food or on an empty stomach. In order
not to leave out any
tablets, they should take the drug at the same time every day. They
should not take a double
dose to make up for a forgotten dose. They should take the next dose
at the usually scheduled
time.
The duration of treatment is not limited.
4.3
CONTRAINDICATIONS
Hypersensitivity to any ingredient of the drug, hypersensitivity to
any sulphonamide drug and
anuria.
4.4
SPECIAL WARNINGS