Locoid Cream 0.1%
- Name:
Locoid Cream 0.1%
- Company:
LEO Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/11/20
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LEO Pharma
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 23 November 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 November 2020 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
Updated on 16 December 2019 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 28 June 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 1 March 2019 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to date format (month YYYY)
Updated on 14 August 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 14 August 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Introduction of PRAC wording for corticosteroids - blurred vision - in section 4.4 and 4.8Introduction of PRAC wording for corticosteroids - blurred vision - in section 4.4 and 4.8
Updated on 2 February 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 2 February 2017 PIL
Reasons for updating
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 31 October 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 31 October 2016 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number
Change to section 10 - Date of revision of the text
Updated on 25 October 2016 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 2 July 2015 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Include HPRA e-mail address 'medsafety@hpra.ie' in Reporting of Suspected Adverse Reactions section.
Updated on 26 May 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The date of revision is updated to May 2015
Updated on 21 May 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 10 July 2014 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 June 2014 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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.
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
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. 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
Updated on 18 June 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 5 July 2013 PIL
Reasons for updating
- Change of manufacturer
Updated on 4 July 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The cetostearyl alcohol may cause local skin reactions (e.g contact dermatitis) and the butyl and propyl parahydroybenzoate may cause allergic reactions which can be delayed.
Updated on 25 July 2012 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 June 2012 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 14 March 2012 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 April 2010 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Locoid CreamSPC
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:
|
System Organ Class |
Rare ›1/10,000‹1/1000 |
Very Rare ‹1/10,000 |
Not Known cannot be estimated from the available data |
|
Immune system disorders |
|
|
Hypersensitivity |
|
Endocrine discorders |
|
Adrenal suppression |
|
|
Skin and subcutaneous |
Skin atropty, often irreversible, with thinning of the epidermisTelangiectasia Purpura Skin striae Pustular acne Perioral dermatitis Rebound effect skin depigmentation Dermatitis and eczema including contact dermatitis |
|
|
10. DATE OF REVISION OF THE TEXT
March 2010
Updated on 16 December 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
see 6.1 has been changed to read see section 6.1
10. DATE OF REVISION OF THE TEXT
Changed from August 2008 to November 2008
Updated on 16 December 2008 PIL
Reasons for updating
- Change to date of revision
- Change to further information section
Updated on 25 August 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: (QUALITATIVE AND QUANTITATIVE COMPOSITION) addition of
“Excipients: contains cetostearyl alcohol 7.20% w/w, propyl parahyroxybenzoate (E216) 0.1% w/w and butyl parahydroxybenzoate 0.05% w/w”
“For excipients, see 6.1” was changed to read “For a full list of excipients, see section 6.1”
Section 6.1. List of excipients, Citric acid anhydrous, changed to read Anhydrous Citrus acid.
Addition of (E216)
Section 6.2: (Incompatibilities) “None stated” has been changed to read “Not applicable”.
6.3. Shelf life, Three years, change to read, 3 years
Section 6.5: (Nature and contents of container) addition of “Not all pack sizes may be marketed”.
Section 9: (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION) updated to read:
Date of first authorisation: 14 October 1977
Date of last renewal: 14 October 2007.
Section 10: (DATE OF REVISION OF THE TEXT) updated to August 2008.
Updated on 21 August 2008 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 29 June 2006 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd
Section 8: Marketing Authorisation Number changed to 1241/5/1
Section 10: Date of Revision of the Text changed to September 2005
Updated on 26 June 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 May 2005 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 April 2005 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 16 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)