Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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. |
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 |
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 Tablet coating: Opadry yellow: Hypromellose (E464) |
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
| Drug | Countries | |
|---|---|---|
| INSPRA | Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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