ISOMONIT Prolonged release tablet Ref.[49866] Active ingredients: Isosorbide mononitrate

Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: ROWEX LTD, Newtown, Bantry, Co Cork, Ireland

Product name and form

Isomonit Retard 60 mg Prolonged-release tablets.

Pharmaceutical Form
Prolonged release tablet. Round, white, biplane tablet with one-sided score notch and facet.

Qualitative and quantitative composition

Each tablet contains 60.0 mg isosorbide mononitrate.

Excipient(s) with known effect: Also contains lactose monohydrate, 25.7mg per tablet.

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 Colloidal anhydrous silica Povidone 25000 Talc Microcrystalline cellulose Calcium hydrogen phosphate Magnesium stearate

Pack sizes and marketing

PVC/Aluminium blister packs.

Pack size: 30 tablets.

Marketing authorization holder

ROWEX LTD, Newtown, Bantry, Co Cork, Ireland

Marketing authorization dates and numbers

PA0711/023/001

Date of first authorisation: 10^th December 1998
Date of last renewal: 10^th December 2008

Drugs

Drug	Countries
ISOMONIT	Australia, Estonia, Ireland, Lithuania

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