EPSITRON Tablet Ref.[28205] Active ingredients: Captopril

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Remedica Ltd., Aharnon St., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Epsitron 25 mg tablets.

Epsitron 50 mg tablets.

Pharmaceutical Form

Tablet.

Epsitron 25 mg tablets: White, square, normal convex tablet, quarter cut on one side and embossed with “CA25” on the other side. The tablets can be divided into equal doses.

Epsitron 50 mg tablets: White, oval, normal convex tablets with Remedica’s logo on one side.

Qualitative and quantitative composition

Epsitron 25 mg tablets: Each tablet contains captopril 25 mg.

Epsitron 50 mg tablets: Each tablet contains captopril 50 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Captopril

Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors). Inhibition of ACE results in decreased plasma angiotensin-II, which leads to decreased vasopressor activity and to reduced aldosterone secretion. In patients with hypertension, captopril causes a reduction in supine and erect blood pressure, without inducing any compensatory increase in heart rate, nor water and sodium retention.

List of Excipients

Pregelatinized starch
Microcrystalline cellulose
Colloidal silicon dioxide
Stearic acid

Pack sizes and marketing

Epsitron 25 mg tablets: PVC/PVDC/Aluminium blisters. Pack-sizes of 20, 40, 60, 100 and 1000 tablets.

Epsitron 50 mg tablets: PVC/PVDC/Aluminium blisters. Pack-sizes of 20, 100, 500 and 1000 tablets.

PP containers with PE closure. Pack-sizes of 60, 100, 500 and 1000 tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd., Aharnon St., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Epsitron 25 mg tablets: 11128
Epsitron 50 mg tablets: 12097

Epsitron 25 mg tablets:

Date of first authorization: 17 March 1987
Date of latest renewal: 22 December 2010

Epsitron 50 mg tablets:

Date of first authorization: 31 January 1989
Date of latest renewal: 30 September 2011

Drugs

Drug Countries
EPSITRON Albania, Cyprus, Hong Kong, Singapore

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.