MONOREM Prolonged-release tablet Ref.[27871] Active ingredients: Isosorbide mononitrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str, Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Monorem R 60 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

White, oval tablets, scored on both sides and embossed with R/R on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each prolonged-release tablet contains diluted isosorbide mononitrate equivalent to 60 mg isosorbide mononitrate.

Excipient(s) with known effect:

This product contains 215 mg lactose.

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
Hypromellose
Maize starch
Glyceryl palmitostearate
Magnesium stearate

Pack sizes and marketing

Aluminium/PVC blisters. Pack sizes of 30 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

21764

Date of first authorization: 27 May 2013
Date of latest renewal: 03 March 2020

Drugs

Drug Countries
MONOREM Cyprus, Malta

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