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
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
4.1. 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.
5.1. Pharmacodynamic properties
ATC Code: A01A C03
None stated.
5.2. Pharmacokinetic properties
None stated.
5.3. Preclinical safety data
None stated.
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
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.
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).