Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
Zestril 5 mg, 10 mg, and 20 mg tablets.
| Pharmaceutical Form |
|---|
|
5 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 5” on one side and bisected on the other side. Diameter 6 mm. The tablet can be divided into equal doses. 10 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 10” on one side and plain on the other side. Diameter 8 mm. 20 mg tablets: round, brownish-red, uncoated, biconvex tablet with “♥ 20” on one side and plain on the other side. Diameter 8 mm. |
Each tablet contains lisinopril dihydrate equivalent to 5 mg, 10 mg, or 20 mg anhydrous lisinopril.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lisinopril |
Lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin-converting enzyme (ACE) that catalyses the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased concentrations of angiotensin II which results in decreased vasopressor activity and reduced aldosterone secretion. |
| List of Excipients |
|---|
|
Mannitol |
5 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 28x1, 30, 42, 50, 56, 60, 84, 98, 100, 400 and 500 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
10 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 30, 50, 56, 84, 98, 100 and 400 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
20 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 30, 42, 50, 56, 56x1, 60, 84, 98, 100, 400 and 500 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
Not all pack sizes may be marketed.
Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
5 mg: PL 43252/0031
10 mg: PL 43252/0032
20 mg: PL 43252/0033
Date of first authorisation: 8 June 2000
Date of first renewal: 1 August 2010
| Drug | Countries | |
|---|---|---|
| ZESTRIL | Australia, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Ireland, Italy, Japan, Malta, Netherlands, Singapore, United Kingdom, United States, South Africa |
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