ZOFENIL Film-coated tablet Ref.[49805] Active ingredients: Zofenopril

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, 1611 Luxembourg

Product name and form

ZOFENIL 7.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White round film-coated tablets with convex faces.

Qualitative and quantitative composition

Each ZOFENIL 7.5 mg tablet contains 7.5 mg of zofenopril calcium as 7.2 mg of zofenopril.

Excipients with known effect: Each ZOFENIL 7.5 mg film-coated tablet contains 17.35 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Zofenopril

The beneficial effects of zofenopril in hypertension and acute myocardial infarction appear to result primarily from the suppression of the plasma renin-angiotensin aldosterone system. Inhibition of ACE (Ki 0.4nM in rabbit lung for arginine salt of zofenoprilat) results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to reduced aldosterone secretion.

List of Excipients

Core:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate
Colloidal anhydrous silica

Coat:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Macrogol 6000

Pack sizes and marketing

Blister PVDC /PVC/aluminium or Aclar/Aluminium or PVC/PE/PVDC/Aluminium, packs of: 12, 14, 15, 28, 30, 48, 50, 50 unit doses, 56, 56 unit doses, 90 or 100 film coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, 1611 Luxembourg

Marketing authorization dates and numbers

PA0865/003/001

Date of first authorisation: 04 March 1999
Date of last renewal: 30 July 2008

Drugs

Drug Countries
ZOFENIL Austria, Germany, France, Ireland, Poland

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