Updated in line with CCDS

-Align to QRD template

-Clarify indications, duration, population

-Update warnings in relation to eyes and eyelids

-Update information in pregnancy and breastfeeding

-Update adverse effects

Addition of a safety warning regarding flammability

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.

Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and special precautions for use.

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

Although generally regardeding as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. 

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 Lipocream SPC

New Insertions in Red and deletions in Blue

4.4       Special warnings and 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

            The following adverse drug reactions were reported:

10.       Date of Revision of the Text

March 2010

Section 2.         Qualitative and Quantitative Composition

Addition of : Excipients: Contains cetostearyl alcohol 6% w/w and propyl parahydroxylbenzoate (E216) 0.05% w/w.

For excipients, see 6.1 changed to read For a full list of excipients, excipients, see 6.1

Section 6.5        Nature and contents of container

Inserted: Not all pack may be marketed.

Section 9:  Date of First Authorisation/Renewal of the

Authorisation

Updated from: 4^th May 1984 / 4^th May 2004.

To read:

            Date of first authorization: 04 May 1984

            Date of last renewal: 04 May 2004. upda

Section 10.        Date of Revision of the Text: Updated from September 2005 to November 2009.

Section 6.1:      Change in excipients

- Addition of Benzyl alcohol

- Replaced “methyl parahydroxybenzoate (E218)” with “propyl parahydroxybenzoate (E216)”

Section 6.3: Shelf life reduced to 3 years

Section 6.4: Addition of storage precaution “Do not refrigerate or freeze”

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

Section 8: Marketing Authorisation Number changed to 1241/5/2

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