- hydrocortisone sodium succinate
This information is intended for use by health professionals
Hydrocortisone 2.5 mg Muco-Adhesive Buccal Tablets
Corlan® 2.5 mg Muco-Adhesive Buccal Tablets
Each tablet contains 2.5mg Hydrocortisone in the form of the ester hydrocortisone sodium succinate
For excipients, see 6.1
Muco-adhesive buccal tablet
Small white tablet engraved 'Corlan Evans' on one side
Local use in previously diagnosed aphthous ulceration of the mouth, whether simple or occurring as a complication in diseases such as sprue, idiopathic steatorrhoea or ulcerative colitis.
Adults and elderly:
Hydrocortisone buccal tablets should not be sucked, but kept in the mouth and allowed to dissolve slowly in close proximity to the ulcers. One tablet should be used in this way four times a day. If the ulcers have not healed after 5 days of treatment (completion of one pack), or if they recur quickly after healing, a doctor should be consulted.
Children under 12 years of age:
Children under 12 years old must see a doctor before starting each course of Hydrocortisone buccal tablets.
Hydrocortisone buccal tablets should not be used in the presence of oral infection unless effective appropriate anti-infective therapy is also employed. Hypersensitivity to any component of the product.
If aphthous ulceration is severe or recurring, serious underlying disease should be excluded.
Efficacy and safety of Hydrocortisone buccal tablets for treatment of adrenal insufficiency have not been established. Hydrocortisone buccal tablets should not be used for treatment of adrenal insufficiency and particularly should never be used for treatment of adrenal crisis because of the risk of insufficient cortisol release.
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.
Corticosteroids may worsen diabetes.
Occasionally, topical therapy may result in an exacerbation of local infection.
Hypersensitivity reactions have occurred with corticosteroids, mainly when administered topically.
Most topically applied corticosteroids may, under certain circumstances, be absorbed in sufficient amounts to produce systemic effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Treatment is unlikely to be needed in cases of acute overdosage.
ATC Code: A01A C03
Store below 25°C. Replace cap firmly after use.
Tamper evident polypropylene container with polythene lid containing 20 tablets.
Tubular glass vials with snap-plug closure containing 20 tablets.
Accord Healthcare Limited
319 Pinner Road
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL
+44 (0)1895 627 480
+44 (0)895 627421
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