ISOKET RETARD Prolonged release tablet Ref.[28019] Active ingredients: Isosorbide dinitrate

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

Isoket Retard 20 Tablets.

Pharmaceutical Form

Prolonged release tablets.

White with break score, marked IR 20 on the upper side and with SCHWARZ PHARMA on the reverse side.

Qualitative and quantitative composition

Each tablet contains isosorbide dinitrate 20 mg in a prolonged release formulation.

Excipients with known effect: 157.95 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Isosorbide dinitrate

Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive nitrates, is a vasodilator.

List of Excipients

Lactose monohydrate
Talc
Polyvinyl acetate
Magnesium stearate
Potato starch

Pack sizes and marketing

Cartons of blister strips of polypropylene (PP) and aluminium or of PP/PP.

Pack sizes 50, 56, 60, 84 and 90 tablets.

Only the pack sizes marked in bold are currently marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 20011/0048

Date of first authorisation: 01 June 1981
Date of latest renewal: 30 June 2008

Drugs

Drug Countries
ISOKET Germany, Estonia, Ireland, Lithuania, Malta, Mexico, United Kingdom

© 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.