INSPRA Film-coated tablet

Active ingredients: Eplerenone

Product name and form

INSPRA 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

25 mg tablet: yellow tablet with stylized “Pfizer” on one side of tablet, “NSR” over "25"on the other side of tablet.

Qualitative and quantitative composition

Each tablet contains 25 mg of eplerenone.

Excipients with known effect: Each 25 mg tablet contains 35.7 mg of lactose monohydrate (see section 4.4).

For the full list of excipients see section 6.1.

Active Ingredient
Description

Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors. Eplerenone prevents the binding of aldosterone, a key hormone in the renin-angiotensin-aldosterone-system (RAAS), which is involved in the regulation of blood pressure and the pathophysiology of CV disease.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Hypromellose (E464)
Sodium laurilsulfate
Talc (E553b)
Magnesium stearate (E470b)

Tablet coating:

Opadry yellow:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80 (E433)
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

Opaque PVC/Al blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets.

Opaque PVC/Al perforated unit dose blisters containing 10 × 1, 20 × 1, 30 × 1, 50 × 1, 90 × 1, 100 × 1 or 200 × 1 (10 packs of 20 × 1) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0615

21/09/2004

Drugs

Drug
Countries
Austria, Australia, Canada, Cyprus, Germany, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States