Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom
The tablets are indicated for the treatment of mild or moderate ulcerative colitis in active phase, as add-on therapy to 5-ASA containing drugs in patients who are non-responders to 5-ASA therapy in active phase.
One Clipper 5 mg tablet a day to be taken in the morning before or after a light breakfast.
Therapy cycles of not more than four weeks are recommended.
No special dose adjustment is recommended. However, experience with Clipper in the elderly is limited.
There is no experience with Clipper in the paediatric population. Clipper is not recommended for use in children.
Tablets must be swallowed whole with a little liquid. The tablets should not be broken or chewed.
No cases of overdose have so far been reported. However, in case of acute or chronic intake exceeding the therapeutic dose, the following measures should be taken:
Acute:
Ingestion of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action.
Chronic:
Monitoring of adrenal reserve may be indicated. Treatment should be continued at a dose sufficient to control the ulcerative colitis and no more.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC/Al/PVDC blister.
Packs of 10 or 30 tablets.
Not all pack sizes may be marketed.
No special requirements.
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