INNOVACE Tablet

Active ingredients: Enalapril

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

* 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 is a derivative of two amino-acids, L-alanine and L-proline. After absorption, enalapril is hydrolysed to enalaprilat, which inhibits ACE. Inhibition of ACE results in decreased plasma angiotensin II, which leads to increased plasma renin activity (due to removal of negative feedback of renin release), and decreased aldosterone secretion.

List of Excipients

Sodium hydrogen carbonate
Maize starch
Pregelatinised 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

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

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
Ireland, United Kingdom