Co-Prenessa 8mg+2,5mg tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

perindopril (perindopril erbumine), indapamide

Доступна с:

KRKA d.d.

код АТС:

C09BA04

ИНН (Международная Имя):

perindopril (perindopril erbumine), indapamide

дозировка:

8mg+2,5mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(30/3x10/) blisters

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2015-05-15

Характеристики продукта

1.3.1
Perindopril erbumine + Indapamide
SPC, Labeling and Package Leaflet
AM
SmPCPIL129191_4
22.03.2019 – Updated: 18.06.2019
Page 1 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Co-Prenessa
®
8 mg/2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Prenessa 8 mg/2.5 mg tablets
Each tablet contains 8 mg perindopril erbumine (equivalent to 6.676 mg
perindopril) and 2.5 mg
indapamide.
Excipient:
lactose
117.476 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Perindopril erbumine/Indapamide 8 mg/ 2.5 mg
White to almost white, round, slightly biconvex, one side scored
tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-Prenessa 8 mg/2.5 mg tablets is indicated as substitution therapy
for treatment of essential
hypertension, in patients already controlled with perindopril and
indapamide given concurrently at the
same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
The usual dose is one Co-Prenessa 8 mg/2.5 mg tablet per day as a
single dose, preferably to be taken
in the morning and before a meal.
_ _
_Elderly (see section 4.4)_
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly
may be treated if renal function is normal and after considering blood
pressure response.
_Patients with renal impairment (see section 4.4) _
In patients with severe and moderate renal impairment (creatinine
clearance below 60 ml/min),
treatment is contraindicated.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification is
required.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium - after one week
at the beginning and then after 2 to 3 months.
1.3.1
Perindopril erbumine + Indapamide
SPC, Labeling and Package Leaflet
AM
SmPCPIL129191_4
22.03.2019 – Updated: 18.06.2019
Page 2 of 17
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, n