Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Organon Pharma (UK) Limited, The Hewett Building, 14 Hewett Street, London EC2A 3NP, United Kingdom
Innovace 2.5 mg Tablets.
Innovace 5 mg Tablets.
Innovace 10 mg Tablets.
Innovace 20 mg Tablets.
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Tablets.
* The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each tablet contains 2.5 mg of enalapril maleate.
Excipient: each tablet contains 99 mg of lactose monohydrate.
Each tablet contains 5 mg of enalapril maleate.
Excipient: each tablet contains 198 mg of lactose monohydrate.
Each tablet contains 10 mg of enalapril maleate.
Excipient: each tablet contains 164 mg of lactose monohydrate.
Each tablet contains 20 mg of enalapril maleate.
Excipient: each tablet contains 154 mg of lactose monohydrate.
Excipient(s) with known effect: For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Enalapril |
Enalapril is hydrolysed via hepatic CES 1 to the active metabolite enalaprilat, which acts as an ACE inhibitor. ACE is a peptidyl dipeptidase which catalyses the conversion of angiotensin I to the vasoconstrictor substance angiotensin II and hence inhibition of ACE results in decreased plasma angiotensin II. This also leads to increased plasma renin activity and decreased aldosterone secretion. The mechanism of action of enalapril is therefore primarily via the suppression of the RAAS. However, ACE is identical to kininase II, and so enalapril may also exert its effects by blocking the degradation of bradykinin, a potent vasodepressor peptide. |
| List of Excipients |
|---|
|
Sodium hydrogen carbonate |
Innovace 2.5 mg: All-aluminium blister packages containing 2, 11, 20, 28, 30, 40, 49 × 1, 50, or 100 tablets.
Innovace 5 mg: All-aluminium blister packages containing 2, 14, 20, 28, 28 × 1, 30, 49 × 1, 50, 60, 98, or 100 tablets.
Innovace 10 mg: All-aluminium blister packages containing 28, 49 × 1, 30, 50, 98 or 100 tablets.
Innovace 20 mg: All-aluminium blister packages containing 10, 14, 20, 28, 28 × 1, 30, 49 × 1, 50, 56, 60, 84, 90, 98, 100 or 500 tablets.
Not all pack sizes may be marketed.
Organon Pharma (UK) Limited, The Hewett Building, 14 Hewett Street, London EC2A 3NP, United Kingdom
2.5 mg Tablet: PL 00025/0220
5 mg Tablet: PL 00025/0194
10 mg Tablet: PL 00025/0195
20 mg Tablet: PL 00025/0196
Date of first authorisation:
| 2.5 mg tablets | PL 00025/0220 | first licensed | 17 April 1986 |
| 5 mg tablets | PL 00025/0194 | first licensed | 06 December 1984 |
| 10 mg tablets | PL 00025/0195 | first licensed | 06 December 1984 |
| 20 mg tablets | PL 00025/0196 | first licensed | 06 December 1984 |
Date of latest renewal: 01 November 2009
| Drug | Countries | |
|---|---|---|
| INNOVACE | Ireland, United Kingdom |
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