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VASCACE Film-coated tablet (2012)

Active ingredients: Cilazapril

Product Name and Form

Vascace 0.5 mg Film-coated Tablets.

Vascace 1 mg Film-coated Tablets.

Vascace 2.5 mg Film-coated Tablets.

Vascace 5 mg Film-coated Tablets.

Pharmaceutical form

Film-coated tablet:

White, oval, biconvex film-coated tablets with a score on one side and imprinted “CIL 0.5” on the other side.

Light yellow, oval, biconvex film-coated tablets with a score on one side and imprinted “CIL 1” on the other side.

Dull red, biconvex film-coated tablets with a score on one side and imprinted “CIL 2.5” on the other side.

Reddish-brown, oval, biconvex film-coated tablets with a score on one side and imprinted “CIL 5” on the other side.

The tablet can be divided into equal halves.

Qualitative and Quantitative Composition

Each film-coated tablet contains:

0.522 mg cilazapril equivalent to 0.5mg cilazapril anhydrous
1.044 mg cilazapril equivalent to 1mg cilazapril anhydrous
2.61 mg cilazapril equivalent to 2.5 mg cilazapril anhydrous
5.22 mg cilazapril equivalent to 5 mg cilazapril anhydrous

Excipients:

Each tablet contains 82.028 mg lactose monohydrate (0.5mg)
Each tablet contains 81.506 mg lactose monohydrate (1mg)
Each tablet contains 124.39 mg lactose monohydrate (2.5mg)
Each tablet contains 121.78 mg lactose monohydrate (5mg)

For a full list of excipients, see section 6.1.

Chemical substance
Description
Cilazapril

Cilazapril is a specific, long-acting angiotensin-converting enzyme (ACE) inhibitor which suppresses the renin-angiotensin-aldosterone system and thereby the conversion of the inactive angiotensin I to angiotensin II, which is a potent vasoconstrictor.

List of excipients

In the tablet core:

Lactose monohydrate
Maize starch
Hypromellose 3cP
Talc
Sodium stearyl fumarate

In the film coat:

Hypromellose 6cP
Talc
Titanium dioxide E171
Vascace 1 mg: in addition Iron oxide yellow (E172)
Vascace 2.5 mg: in addition Iron oxide yellow (E172) and Iron oxide Red (E172)
Vascace 5 mg: in addition Iron oxide red (E172)

Pack sizes and Marketing

ALU/ALU blisters containing 14, 20, 28, 30, 50, 56, 60, 98 film-coated tablets.

Amber glass bottles containing 28, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Date of first authorisation: 26 October 1990
Date of last renewal: 7 December 2001

Marketing authorization number:

0.5mg Tablets: PL 00031/0244
1.0mg Tablets: PL 00031/0245
2.5mg Tablets: PL 00031/0246
5.0mg Tablets: PL 00031/0247
 
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