Amprilan HL

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ramipril, hydrochlorothiazide

Доступна с:

KRKA d.d.

ИНН (Международная Имя):

ramipril, hydrochlorothiazide

дозировка:

2,5mg+12,5mg

Фармацевтическая форма:

tablets

Тип рецепта:

Prescription

Характеристики продукта

Summary of product characteristics
CONFIDENTIAL
1.3.1
Ramipril + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
SmPCPIL044605_4
18.11.2013 – Updated: 10.06.2014
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amprilan HL tablets 2.5 mg/12.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amprilan HL tablets 2.5 mg/12.5 mg: Each tablet contains ramipril 2.5
mg and
hydrochlorothiazide 12.5 mg
3.
PHARMACEUTICAL FORM
Tablet.
Flat, capsule shape tablete, white to off- white, scored on one side
and marked with 12.5 on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension that cannot be adequately controlled with
ramipril alone (or
hydrochlorothiazide alone).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of the fixed combination ramipril/hydrochlorothiazide
is only recommended
after individual titration of the doses with the single components.
The dose may be increased at
intervals of at least 3 weeks. The usual maintenance dose is 1 tablet
Amprilan HL (2.5 mg
ramipril and 12.5 mg hydrochlorothiazide) in the morning. The maximal
dose is 2 tablets
Amprilan HL (5 mg ramipril and 25 mg hydrochlorothiazide).
_Prior diuretic therapy_
The diuretic therapy should be stopped or the dose reduced, two to
three days prior to the start
of a treatment with ramipril/hydrochlorothiazide, to prevent the
development of symptomatic
hypotension. Renal function should be assessed before starting the
treatment.
_Patients with impaired renal function:_
In patients with a creatinine clearance greater than 0.5 ml/s or serum
creatinine 265 µmol/L
(3 mg/100 ml) can be assigned regular dose.
_Impaired hepatic function:_
In patients with mild to moderate impairment of hepatic function the
dose of ramipril should be
titrated before changing to ramipril/hydrochlorothiazide tablets.
Ramipril/hydrochlorothiazide tablets should not be used for patients
with severely impaired
hepatic function and/or cholestasis (see also section 4.3).
_Children and adolescents (<18