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Astellas Pharma Ltd
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH
Telephone: +44 (0)1784 419615
Fax: +44 (0)1784 419583
Medical Information Direct Line: 0800 783 5018
Medical Information e-mail: medinfo@gb.astellas.com

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Summary of Product Characteristics last updated on the eMC: 13/04/2011
SPC Locoid Lipocream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 13/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises.  This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.

 

In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7.  This date is updated to 13th December 2010.
Updated on 10/08/2009 and displayed until 13/04/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   15-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2       Posology and Method of administration

 

For topical application.

 

The following instruction has been deleted -

Dosage: To be applied evenly and sparingly two or three times daily

 

and has been replaced with -

Dosage: To be applied evenly and sparingly no more than twice daily

 

4.4       Special warnings and precautions for use

 

The following paragraph has been added:

 

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

 

4.8       Undesirable effects

 

            The following paragraphs has been deleted -

 

            Local atrophic changes may occur in 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.

 

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

 

and replaced with the following table –

 

System Organ Class

Rare

>/10,000,<1/1000

Very rare

</10,000

Not known

Immune system disorders

 

 

Hypersensitivity

Endocrine disorders

 

Adrenal suppression

 

Skin and subcutaneous tissue disorders

Skin atropy, often irreversible, with thinning of the epidermis

Telangiectasia

Skin striae

Pustular acne

Perioral dermatitis

Rebound effect

Skin depigmentation

Dermatitis and eczema, including contact dermatitis

 

 
Updated on 03/08/2009 and displayed until 10/08/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • 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
Date of revision of text on the SPC:   15-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2       Posology and Method of administration

 

For topical application to the scalp.

 

The following instruction has been deleted -

Dosage: To be applied evenly and sparingly two or three times daily

 

and has been replaced with -

Dosage: To be applied evenly and sparingly no more than twice daily

 

4.4       Special warnings and precautions for use

 

The following paragraph has been added:

 

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

 

4.8       Undesirable effects

 

            The following paragraphs has been deleted -

 

Local atrophic changes may occur in 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.

 

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

 

and replaced with the following table –

 

System Organ Class

Rare

>/10,000,<1/1000

Very rare

</10,000

Not known

Immune system disorders

 

 

Hypersensitivity

Endocrine disorders

 

Adrenal suppression

 

Skin and subcutaneous tissue disorders

Skin atropy, often irreversible, with thinning of the epidermis

Telangiectasia

Skin striae

Pustular acne

Perioral dermatitis

Rebound effect

Skin depigmentation

Dermatitis and eczema, including contact dermatitis

 

 

 
Updated on 11/07/2007 and displayed until 03/08/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
9. Date of first authorisation / renewal of the authorisation
renewed 19 December 2003
Updated on 20/06/2006 and displayed until 11/07/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8    The following sentence has been added.  The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate may cause allergic reactions which can be delayed. 
 
6.1    Change in preservative (methyl parahydroxybenzoate removed and replaced with propyl parahydroxybenzoate and benzyl alcohol added.)
 
6.3    The shelf life has changed from five to three years.
 
6.4    Do not refrigerate or freeze has been added.
 
 
Updated on 01/02/2006 and displayed until 20/06/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/07/2004 and displayed until 01/02/2006
Reasons for adding or 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 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments 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. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Legal Category
Updated on 14/01/2002 and displayed until 22/07/2004
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Addition of Legal Category
Updated on 10/08/2001 and displayed until 14/01/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/01/2000 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 28/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydrocortisone butyrate