Locoid Ointment 0.1%

  • Name:

    Locoid Ointment 0.1%

  • Company:
    info
  • Active Ingredients:

    Hydrocortisone 17-Butyrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/08/18

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Summary of Product Characteristics last updated on medicines.ie: 1/3/2019

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LEO Pharma

LEO Pharma

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Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
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1 - 0 of 41 items.Total: Infinity pages

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 1 March 2019 SmPC

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 - how to report a side effect

Updated on 14 August 2018 SmPC

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 4.8

Updated on 3 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 February 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 31 October 2016 SmPC

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 31 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

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 SmPC

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

Section 4.8
Include HPRA e-mail address 'medsafety@hpra.ie' in Reporting of Suspected Adverse Reactions section.

Updated on 26 May 2015 SmPC

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 HPRA contact details for side-effect reporting have been updated to reflect the name change from IMB to HPRA
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 SmPC

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 4.8 - Undesirable effects
  • 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.

 

 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

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 10 July 2013 SmPC

Reasons for updating

  • 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

Correction of spacing errors

Updated on 5 July 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 25 July 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

Change Detail

 

7              Marketing Authorisation Holder

 

Astellas Pharma Co Ltd

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

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 25 February 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 April 2010 SmPC

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 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:

           System Organ Class

                Rare ›1/10,000‹1/1000

            Very Rare ‹1/10,000

             Not Known cannot be estimated from the  available data

Im                     Immune system disorders

 

 

H                                     Hypersensitivity

En                  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 9 December 2008 SmPC

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

 

 

10.       DATE OF REVISION OF THE TEXT

 

Changed from October 2008 to November 2008

Updated on 25 August 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

 

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

 

Section 6.2: (Incompatibilities) “None stated” has been changed to read “Not applicable”.

 

6.3.      Shelf life, Five years, change to read, 5 years

 

Section 6.4       Special precautions for storage, Store in original package

 

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 29 June 2006 SmPC

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 1241/5/3

 

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

Updated on 6 April 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)