MONOREM Tablet Ref.[27870] Active ingredients: Isosorbide mononitrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Monorem 20 mg tablets.

Pharmaceutical Form

Tablet.

White, round, flat, scored tablets with Remedica’s logo on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains diluted isosorbide mononitrate equivalent to 20 mg isosorbide mononitrate.

Excipients with known effect:

Each tablet contains 146,7 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Isosorbide mononitrate

Isosorbide mononitrate is an organic nitrate, which, in common with other cardioactive nitrates, is a vasodilator. It produces decreased left and right ventricular end-diastolic pressures to a greater extent than the decrease in systemic arterial pressure, thereby reducing afterload and especially the preload of the heart.

List of Excipients

Lactose monohydrate
Talc
Silica, colloidal anhydrous
Maize starch
Cellulose, microcrystalline
Magnesium stearate

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 50, 100 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

21074

Date of first authorization: 24 August 2011
Date of latest renewal: 07 August 2018

Drugs

Drug Countries
MONOREM Cyprus, Malta

© 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.