ELANTAN LA Prolonged release capsule Ref.[49650] Active ingredients: Isosorbide mononitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK

Product name and form

Elantan LA 25 mg prolonged release capsules.

Pharmaceutical Form

Prolonged release capsules.

Hard capsule with brown cap and white body, containing white to off-white pellets.

Qualitative and quantitative composition

Each prolonged release capsule contains 25 mg isosorbide mononitrate.

Excipients: Each prolonged release hard capsule contains 6.71 mg lactose monohydrate and approximately 8-12 mg sucrose.

For a full excipient list, 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

Core:

Lactose monohydrate
Purified talc
Ethyl cellulose
Macrogol 20000
Hydroxypropyl cellulose
Sucrose
Corn starch

Capule shell:

Gelatin
Titanium dioxide
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

Cartons of blister strips of PVC and aluminium or of PP and aluminium.

Aluminium foil thickness 20 μm or 16 μm.

Pack size: 28 capsules.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0046

28 February 2008

Drugs

Drug Countries
ELANTAN Estonia, Hong Kong, Ireland, Mexico, United Kingdom, South Africa

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