Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Proveca Pharma Limited, 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
AQUMELDI 0.25 mg orodispersible tablets.
| Pharmaceutical Form |
|---|
|
Orodispersible tablet. White, round, biconvex orodispersible tablets, 2 mm in diameter. |
Each orodispersible tablet contains 0.25 mg of enalapril maleate.
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 |
|---|
|
Mannitol (E421) |
High density polyethylene bottle with polypropylene cap (equipped with a child-resistant, tamper evident closure system and an integrated silica desiccant) and one scoop to allow extraction of the tablets from the bottle.
AQUMELDI is provided in bottles of 50, 100 or 200 tablets, each.
Not all pack sizes may be marketed.
Proveca Pharma Limited, 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
EU/1/23/1717/001
EU/1/23/1717/002
EU/1/23/1717/003
| Drug | Countries | |
|---|---|---|
| AQUMELDI | Austria, Estonia, Croatia, Ireland, Italy, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
