ISMO Retard prolonged-release tablet Ref.[49794] Active ingredients: Isosorbide mononitrate

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Mangere, AUCKLAND Telephone: (09) 918 5100 Fax: (09) 918 5101

Product name and form

ISMO 40 retard tablets.

Pharmaceutical Form

ISMO 40 retard prolonged-release tablets for oral administration are white, round, coated tablets with a diameter of 6.5–7.0 mm and a thickness of 3.3–3.8 mm.

Qualitative and quantitative composition

Each prolonged-release tablet contains 40 mg isosorbide mononitrate.

Contains glucose syrup, lactose and sucrose.

For a 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

Glucose syrup
Llactose
Macrogol 35,000
Magnesium stearate (Ph.Eur.)
Montanglycol wax
Povidone K25
Poly[butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate] (1:2:1)
Sucrose
Highly dispersed silica
Talc
Kaolin
Titanium dioxide (E171)

Pack sizes and marketing

ISMO 40 retard is supplied in blister packs of 30 tablets.

Marketing authorization holder

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Mangere, AUCKLAND
Telephone: (09) 918 5100
Fax: (09) 918 5101

Marketing authorization dates and numbers

Date of first approval: 2 December 2010

Drugs

Drug Countries
ISMO Germany, Italy, New Zealand, United Kingdom, South Africa

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