This information is intended for use by health professionals

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

Excipient with known effect:

Each tablet contains 67.742mg lactose

For the full list of excipients, see section 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

Posology

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.

Paediatric population

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

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hydrocortisone buccal tablets should not be used in the presence of oral infection unless effective appropriate anti-infective therapy is also employed.

4.4 Special warnings and precautions for use

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.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Hypertrophic cardiomyopathy

Hypertrophic cardiomyopathy was reported after administration of hydrocortisone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed.

Excipients

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6 Fertility, 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.

The following side effects may be associated with the use of hydrocortisone with the following frequency:

Not known (cannot be estimated from available data)

System organ class

Frequency

Undesirable effects

Eye disorders

Not known (cannot be estimated from the available data)

Vision, blurred (see also section 4.4)

Cardiac disorders

Not known (cannot be estimated from the available data)

Hypertrophic cardiomyopathy in prematurely born infants (see also section 4.4)

Investigations

Not known (cannot be estimated from the available data)

Weight increased

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.

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

6.2 Incompatibilities

None known.

6.3 Shelf life

12 months.

6.4 Special precautions for storage

Store below 25°C. Replace cap firmly after use.

6.5 Nature and contents of container

Tamper evident polypropylene container with polythene lid containing 20 tablets.

Tubular glass vials with snap-plug closure containing 20 tablets.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

8. Marketing authorisation number(s)

PL 20075/0689

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 12th March 2010

10. Date of revision of the text

29/09/2020