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 is a phenylalkylamine calcium antagonist which blocks the inward movement of calcium ions in cardiac muscle cells, in smooth muscle cells of the coronary and systemic arteries and in cells of the intracardiac conduction system. It lowers heart rate, increases myocardial perfusion and reduces coronary spasm. Because of its effect on the movement of calcium in the intracardiac conduction system, verapamil reduces automaticity, decreases conduction velocity and increases the refractory period.

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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