COLAZIDE Capsule, hard Ref.[27543] Active ingredients: Balsalazide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain

4.1. Therapeutic indications

Colazide is indicated for the treatment of mild-to-moderate active ulcerative colitis and maintenance of remission.

4.2. Posology and method of administration

Posology

Adults

Treatment of active disease

2.25g Balsalazide disodium (3 capsules) three times daily (6.75g daily) until remission or for 12 weeks maximum.

Rectal or oral steroids can be given concomitantly if necessary.

Maintenance treatment

The recommended starting dose is 1.5g Balsalazide disodium (2 capsules) twice daily (3g daily). The dose can be adjusted based on each patient’s response; there may be an additional benefit with a dose up to 6g daily.

Elderly

No dose adjustment is anticipated.

Paediatric Population

Colazide is not recommended in children.

Method of administration

To be swallowed whole with or after food.

4.9. Overdose

To date, there are no reports of overdosage with mesalazine-releasing products. Overdose with large amounts of balsalazide may result in symptoms resembling mild salicylate intoxication. Treatment should be symptomatic.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

No special precautions for storage.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

None.

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