ENAP Tablet Ref.[49833] Active ingredients: Enalapril

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Product name and form

ENAP 5mg Tablets.

Pharmaceutical Form

Tablet.

White oblong tablets with EN 5' embossed and a break notch on one side.

The tablets can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 5mg enalapril maleate.

Excipients with known effect: Each tablet contains 129.8mg lactose monohydrate and 0.712mg sodium.

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
Lactose monohydrate
Maize starch
Talc
Hydroxypropylcellulose
Magnesium stearate

Pack sizes and marketing

ENAP 5mg Tablets are packed in blisters of aluminium – aluminium welded on an internally varnished aluminium support.

ENAP 5mg Tablets are available in pack sizes of 30 tablets and 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0711/028/001

Date of first authorisation: 26 November 1999
Date of last renewal: 26 November 2009

Drugs

Drug Countries
ENAP Albania, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Poland, Romania, Singapore, South Africa

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