Active ingredients: Eplerenone
INSPRA 25 mg film-coated tablets.
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.
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.
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.
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)
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.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/0615
21/09/2004