Change to date format (month YYYY)

Introduction of PRAC wording for corticosteroids - blurred vision - in section 4.4 and 4.8

Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number
Change to section 10 - Date of revision of the text

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

For a the full list of excipients, see section 6.1.

4.         CLINICAL PARTICULARS

4.1        Therapeutic indications

The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids e.g. eczema, dermatitis and psoriasis not caused by micro-organisms.

 4.2        Posology and method of administration

Dosage:  to be applied evenly and sparingly one to two or three times daily.

Adults and older people the elderly: the same dose is used for adults and older  people the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in older people the elderly.

4.3        Contraindications

Hypersensitivity to hydrocortisone or to any of the excipients listed in section 6.1to any of the ingredients of the ointment

This preparation is contraindicated in the presence of untreated viral or fungal infections (mycotic yeast) or parasitic infections, tubercular or syphilitic lesions, ulcerous skin lesions peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.

4.4        Special warnings and special precautions for use

As with all corticosteroids, application to the face, flexures and other areas of thin skin (pilous and genital skin) may cause skin atrophy and increased absorption and should be avoided. Such areas should only be treated with corticosteroids of low potency.

Do not apply to the eyelids in view of the risk of glaucoma simplex or subcapsular cataract.

4.6        Fertility, pregnancy and lactation

Corticosteriods pass the placenta and may therefore influence the foetus. This is only of significance when large areas are treated intensively with corticosteriods of high potency.

4.8        Undesirable 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 preferably  via IMB Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel +353 1 6764971; Fax +353 16762517. Website; www.imb.ie; email:imbpharmacovigilance@imb.ie

5.1        Pharmacodynamic properties

Pharmacotherapeutic group: Moderately potent corticosteroids (group 2) ATC: D07AB The active substance is a well-established topical corticosteroid, with an activity classified as potent.

Mechanism of action

The active principal of Locoid is the synthetic corticosteroid hydrocortisone 17 – butyrate.

It has a rapid anti-inflammatory and vasoconstrictive action. It suppresses the inflammatory reaction while in use and reduces the symptoms of a number of disorders that are often accompanied by pruritus. The underlying condition is not cured.

The effect of corticosteroids may be increased by application of an occlusive dressing that increases penetration of the stratum corneum by a factor of around 10.

5.2        Pharmacokinetic properties

Hydrocortisone 17-butyrate penetrates the skin. Occlusion enhances penetration. It is bound to plasma proteins and is hydrolysed to hydrocortisone in plasma and by the liver. Small amounts of hydrocortisone butyrate are excreted in the urine and with the faeces.

7.         MARKETING AUTHORISATION HOLDER

Astellas Pharma Co. Ltd.

            5 Waterside

            Citywest Business Campus Park

            Naas Road

            Dublin 24

            Ireland

10.        DATE OF REVISION OF THE TEXT

            June 2014

Change Detail

7              Marketing Authorisation Holder

Astellas Pharma Co Ltd

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Locoid Ointment  SPC

New Insertions in Red and deletions in Blue

4.4.      Special warnings and special precautions for use

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

Absorption of corticosteroids can be greatly increased when applied to large areas in particular to skin folds and under (plastic) occlusion, leading to suppression of adrenal cortex function. This can occur quite quickly in children and can lead to suppression of growth hormone secretion

4.8.      Undesirable effects

Local atrophic changes may occur, particularly in skin folds, intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Systemic absorption from such sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated.  Napkins may act as occlusive dressings.

            The following adverse drug reactions were reported:

10.       DATE OF REVISION OF THE TEXT

March 2010

10.       DATE OF REVISION OF THE TEXT

Changed from October 2008 to November 2008

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

Section 8: Marketing Authorisation Number changed to 1241/5/3

Section 10: Date of Revision of the Text changed to September 2005