SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortisone 2.5 mg Muco-Adhesive Buccal Tablets Corlan® 2.5 mg Muco-Adhesive Buccal Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 2.5mg Hydrocortisone in the form of the ester hydrocortisone sodium succinate

For excipients, see 6.1

3    PHARMACEUTICAL FORM

Muco-adhesive buccal tablet

Small white tablet engraved 'Corlan Evans' on one side

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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.

4.2. Posology and Method of Administration

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.

4.3. Contraindications

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.

4.4 Special warnings and precautions for use

If aphthous ulceration is severe or recurring, serious underlying disease should be excluded.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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).

4.9 Overdose

Treatment is unlikely to be needed in cases of acute overdosage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: A01A C03

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Acacia

Magnesium Stearate

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/03/2010

10    DATE OF REVISION OF THE TEXT

05/01/2016