Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 13/04/2011
SPC Locoid Scalp Lotion

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 03/08/2009 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
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

 

4.8       Undesirable effects

 

            The following paragraph 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.

 

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:   11/2005
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 17 January 2001
Updated on 09/01/2006 and displayed until 11/07/2007
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 29/10/2004 and displayed until 09/01/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/07/2004 and displayed until 29/10/2004
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. 6 - Instruction for Use/Handling
  • Change to section 3 - pharmaceutical form
  • Addition of Legal Category
Updated on 10/08/2001 and displayed until 22/07/2004
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/04/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/04/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydrocortisone butyrate