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Innovace Tablets (2012)

Product Name and Form

INNOVACE 2.5 mg Tablets.

INNOVACE 5 mg Tablets.

INNOVACE 10 mg Tablets.

INNOVACE 20 mg Tablets.

Pharmaceutical form

Tablets

Strength Appearance Country
2.5 mg White, oval shaped tablet, one side scored* marked MSD 14, and the other side scored* Belgium, Denmark, Finland, France, Luxembourg, Germany, Norway, Sweden
White, round shaped tablet, one side marked MSD 14, the other side plain Ireland, United Kingdom
5 mg White, rounded triangle shaped tablet, one side scored* the other side marked MSD 712 Austria, Denmark, Finland, Iceland, Ireland, The Netherlands, Sweden, United Kingdom
White, barrel shaped tablet, one side scored* the other side marked RENITEC Belgium, Luxembourg, France, Portugal, Spain
White, round shaped tablet, one side scored*, the other side marked 712 Italy
White, round flat tablet, one side scored* other side plain Greece
White, oval shaped tablet, one side scored*, marked MSD 712 and the other side scored* Germany
10 mg Rust Red, rounded triangle shaped tablet, one side scored*, the other side marked MSD 713 Austria, Denmark, Finland, Iceland, Ireland, The Netherlands, Sweden, United Kingdom
Rust Red, barrel shaped tablet, one side scored*, the other side marked RENITEC Belgium. Luxembourg
Rust Red, oval shaped tablet, one side scored*, and the other side scored*, marked MSD 713 Germany
20 mg Peach, triangle shaped tablet, one side scored*, the other side marked MSD 714 Austria, Denmark, Finland, Iceland, Ireland, The Netherlands, Sweden, United Kingdom
Peach, barrel shaped tablet, one side scored*, the other side marked RENITEC Belgium, France, Luxembourg, Portugal
Peach, round shaped tablet, one side scored quartersect*, the other side marked 714 Italy
Peach, barrel shaped tablet, one side scored* MSDE, the other side marked RENITEC Spain
Peach, round flat tablet, one side scored* other side plain Greece
Peach, oval shaped tablet, one side scored*, and the other side marked MSD 714, scored* Germany

* 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.

For a full list of excipients, see section 6.1.

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-aluminum blister packages containing 2, 11, 20, 28, 30, 40, 49 × 1, 50, or 100 tablets.

Innovace 5 mg - All-aluminum blister packages containing 2, 14, 20, 28, 28 × 1, 30, 49 × 1, 50, 60, 98, or 100 tablets.

Innovace 10 mg - All-aluminum blister packages containing 28, 49 × 1, 30, 50, 98 or 100 tablets.

Innovace 20 mg - All-aluminum 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
Authorization dates

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

Date of first authorisation:

2.5 mg tablets PL 0025/0220 first licensed 17 April 1986

5 mg tablets PL 0025/0194 first licensed 06 December 1984

10 mg tablets PL 0025/0195 first licensed 06 December 1984

20 mg tablets PL 0025/0196 first licensed 06 December 1984

Date of last renewal:

01 November 2009

Marketing authorization number:

2.5 mg Tablet: PL 0025/0220

5 mg Tablet: PL 0025/0194

10 mg Tablet: PL 0025/0195

20 mg Tablet: PL 0025/0196