Co-Prenessa tablets

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

perindopril (perindopril erbumine), indapamide

Disponible desde:

KRKA d.d.

Código ATC:

C09BA04

Designación común internacional (DCI):

perindopril (perindopril erbumine), indapamide

Dosis:

4mg+ 1,25mg

formulario farmacéutico:

tablets

Unidades en paquete:

(30/3x10/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2016-11-10

Ficha técnica

PI_Text002538_1
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Page 1 of 23
1.
NAME OF THE MEDICINAL PRODUCT
Co-Prenessa 2 mg/0.625 mg tablets
Co-Prenessa 4 mg/1.25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Prenessa 2 mg/0.625 mg tablets
Each tablet contains 2 mg perindopril tert-butylamine equivalent to
1.67 mg perindopril and 0.625 mg
indapamide.
Co-Prenessa 4 mg/1.25 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine equivalent to
3.34 mg perindopril and 1.25 mg
indapamide.
Excipient with known effect: lactose
2 mg/0.625 mg tablets
4 mg/1.25 mg tablets
lactose
29.650 mg
59.301 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Co-Prenessa 2 mg/0.625 mg tablets
White to almost white, round, slightly biconvex tablets with bevelled
edges, engraved with short line
on one side.
Co-Prenessa 4 mg/1.25 mg tablets
White to almost white, round, slightly biconvex, one-side scored
tablets with bevelled edges. The
score line is only to facilitate breaking for ease of swallowing and
not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-Prenessa 2 mg/0.625 mg tablets
Essential hypertension.
Co-Prenessa 4 mg/1.25 mg tablets
Treatment of essential hypertension. Co-Prenessa 4 mg/1.25 mg tablets
is indicated in patients whose
blood pressure is not adequately controlled on perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Co-Prenessa 2 mg/0.625 mg tablets
The usual dose is one Co-Prenessa 2 mg/0.625 mg tablet per day as a
single dose, preferably to be
taken in the morning and before a meal. If blood pressure is not
controlled after one month of
CONFIDENTIAL
Co-Prenessa tablets 2 mg/0.625 mg, 4 mg/1.25 mg
MODULE
VOL: 1; P: 11 / 50
PI_Text002538_1
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treatment, the dose can be doubled_._
Co-Prenessa 4 mg/1.25 mg tablets
One Co-Prenessa 4 mg/1.25 mg tablet per day as a single dose,
preferably to be taken in the morning,
and before a meal When possible individual dose titration with the
components is recommended. Co-
Prenessa 4 mg/