ISOPTIN Film‐coated tablet Ref.[51032] Active ingredients: Verapamil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Isoptin 40 mg film‐coated tablets.

Pharmaceutical Form

Film‐coated tablets.

Circular, biconvex, white, film‐coated tablet, embossed 40 on one side and embossed with a triangle on the other side.

Qualitative and quantitative composition

One tablet contains 40mg of Verapamil Hydrochloride.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Verapamil

Verapamil inhibits the transmembrane influx of calcium ions into the heart and vascular smooth muscle cell. The myocardial oxygen demand is lowered directly as a result of the effect on the energy consuming metabolic processes of the myocardial cell and indirectly due to a reduction of the afterload. Due to its effect on coronary vascular smooth muscle, verapamil enhances myocardial blood flow, even in post‐stenotic areas, and relieves coronary spasms. These properties contribute to the anti‐ischaemic and antianginal efficacy of verapamil in all types of coronary artery disease.

List of Excipients

Calcium hydrogen phosphate
Microcrystalline cellulose
Colloidal anhydrous silica
Croscarmellose sodium
Magnesium stearate
Hypromellose
Sodium laurilsulfate
Macrogol 6000
Talc
Titanium dioxide (E171)

Pack sizes and marketing

Isoptin 40mg tablets are packed in PVC blister strips in a carton.

Pack size: 100 tablets/carton.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/003/001

Date of first authorization: 01 April 1980
Date of last renewal: 01 April 2010

Drugs

Drug Countries
ISOPTIN Austria, Australia, Canada, Cyprus, Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Italy, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa

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