ZOFENOPRIL Film-coated tablet Ref.[8399] Active ingredients: Zofenopril

Source: European Medicines Agency (EU) 

Product name and form

Zofenopril 30mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, film-coated tablets with break line on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 30mg of zofenopril calcium, equivalent to 28.7 mg of zofenopril.

For the 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

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Pregelatinized maize starch
Croscarmellose sodium
Hypromellose
Silica, colloidal anhydrous
Magnesium stearate

Film-coat:

Opadry II White (consisting of Polyvinylalcohol, Titanium dioxide (E171), Macrogol 4000, Talc)

Pack sizes and marketing

PVC/PVDC/Aluminium foil blisters in cartons of 14, 28, 30 and 56 film-coated tablets.

Not all pack sizes may be marketed.

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