Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
Colazide 750 mg hard capsules.
| Pharmaceutical Form |
|---|
|
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.
| 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 |
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
| Drug | Countries | |
|---|---|---|
| COLAZIDE | Australia, United Kingdom |
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