COLAZIDE Capsule, hard

Active ingredients: Balsalazide

Product name and form

Colazide 750 mg hard capsules.

Pharmaceutical Form

Capsule, hard.

Size 00 beige gelatin capsules.

Qualitative and quantitative composition

Each capsule contains 750 mg of balsalazide disodium corresponding to balsalazide 612.8 mg and to mesalazine 262.5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

Balsalazide consists of mesalazine linked to a carrier molecule (4-aminobenzoyl-ß-alanine) via an azo bond. Bacterial azo-reduction releases mesalazine as an active metabolite in the colon. Mesalazine is an intestinal anti-inflammatory agent acting locally on the colonic mucosa. Its precise mechanism of action is unknown.

List of Excipients

Magnesium stearate
Colloidal anhydrous silica
Titanium dioxide (E171)
Yellow, red and black iron oxide (E172)

Pack sizes and marketing

High density polyethylene container fitted with tamper-evident, child-resistant, high density polyethylene screw caps.

Pack sizes are: 50, 54, 56, 100, 112, 130, 224 (2 × 112), 260 (2 × 130), 300 (3 × 100), 500 (10 × 50), 672 (6 × 112) and 780 (6 × 130) capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain

Marketing authorization dates and numbers

PL 16973/0019

Date of first authorisation: 18 December 1997

Date of latest renewal: 11 August 2009


Australia, United Kingdom