Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
perindopril (perindopril erbumine), indapamide
KRKA d.d.
C09BA04
perindopril (perindopril erbumine), indapamide
4mg+ 1,25mg
tablets
(30/3x10/) in blister
Prescription
Registered
2016-11-10
PI_Text002538_1 – Updated: 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 – Updated: Page 2 of 23 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/ Izlasiet visu dokumentu