Locoid Lipocream 0.1%

  • Name:

    Locoid Lipocream 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: 21/11/19

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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 Fucidin Ointment Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
Medicine Name Locoid Cream 0.1% Active Ingredients Hydrocortisone 17-Butyrate
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 21 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Addition of a safety warning regarding flammability

Updated on 28 June 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

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 - possible side effects

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 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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 October 2016 SmPC

Reasons for updating

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

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 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.

 

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

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 5 July 2013 SmPC

Reasons for updating

  • 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

improve readability of tabular format

Updated on 3 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 grammar typos and update to section 4.4
The cetostearyl alcohol may cause local skin reactions (e.g contact dermatitis) and the butyl and propyl parahydroxybenzoate may cause allergic reactions which can be delayed

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 27 March 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 May 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 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

 

 

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 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 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: 4th May 1984 / 4th 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.

 

Updated on 10 December 2009 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision
  • Change to product name

Updated on 21 August 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 29 June 2006 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 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

Updated on 26 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 April 2005 SmPC

Reasons for updating

  • 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 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 8 February 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 20 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 18 July 2003 SmPC

Reasons for updating

  • New SPC for new product

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