INNOVACE Tablet Ref.[6785] Active ingredients: Enalapril

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

Product name and form

Innovace 2.5 mg Tablets.

Innovace 5 mg Tablets.

Innovace 10 mg Tablets.

Innovace 20 mg Tablets.

Pharmaceutical Form

Tablets.

StrengthAppearanceCountry
2.5 mgWhite, round shaped tablet, one side marked
MSD 14, the other side plain
Germany, Ireland, Sweden,
United Kingdom
5 mgWhite, rounded triangle shaped tablet,
one side scored*, the other side marked MSD 712
Austria, Finland, France, Germany, Ireland,
Portugal, The Netherlands, Spain, Sweden,
United Kingdom
White, round shaped tablet, one side scored*,
the other side marked 712
Italy
White, round flat tablet, one side scored*,
other side plain
Greece
10 mgRust Red, rounded triangle shaped tablet, one
side scored*, the other side marked MSD 713
Austria, Finland, Germany, Ireland,
The Netherlands, Sweden, United Kingdom
20 mgPeach, rounded triangle shaped tablet,
one side scored*, the other side marked MSD 714
Austria, Belgium, Finland, France, Germany
, Ireland, Luxembourg, Portugal,
The Netherlands, Spain, Sweden, United Kingdom
Peach, round shaped tablet, one side scored
quartersect*, the other side marked 714
Italy
Peach, round flat tablet, one side scored*
other side plain
Greece

* The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Innovace 2.5 mg

Each tablet contains 2.5 mg of enalapril maleate.

Excipient: each tablet contains 99 mg of lactose monohydrate.

Innovace 5 mg

Each tablet contains 5 mg of enalapril maleate.

Excipient: each tablet contains 198 mg of lactose monohydrate.

Innovace 10 mg

Each tablet contains 10 mg of enalapril maleate.

Excipient: each tablet contains 164 mg of lactose monohydrate.

Innovace 20 mg

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
Maize starch
Pre-gelatinised corn starch
Magnesium stearate
Lactose monohydrate
Iron oxide red (E172) – 10 mg and 20 mg tablets only
Iron oxide yellow (E172) – 20 mg tablet only

Pack sizes and marketing

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.

Marketing authorization holder

Organon Pharma (UK) Limited, The Hewett Building, 14 Hewett Street, London EC2A 3NP, United Kingdom

Marketing authorization dates and numbers

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 tabletsPL 00025/0220first licensed17 April 1986
5 mg tabletsPL 00025/0194first licensed06 December 1984
10 mg tabletsPL 00025/0195first licensed06 December 1984
20 mg tabletsPL 00025/0196first licensed06 December 1984

Date of latest renewal: 01 November 2009

Drugs

Drug Countries
INNOVACE Ireland, United Kingdom

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