Active ingredients: Balsalazide
Colazide 750 mg hard capsules.
Capsule, hard.
Size 00 beige gelatin capsules.
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.
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.
Magnesium stearate
Colloidal anhydrous silica
Gelatin
Shellac
Titanium dioxide (E171)
Yellow, red and black iron oxide (E172)
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.
Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
PL 16973/0019
Date of first authorisation: 18 December 1997
Date of latest renewal: 11 August 2009