GlaxoSmithKline Consumer Healthcare

980 Great West Road, Brentford, Middlesex, TW8 9GS

Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700

Medical Information Fax: +44 (0)20 8047 6860

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Summary of Product Characteristics last updated on the eMC: 17/03/2011

SPC	Alphosyl HC Cream

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 17/03/2011 and displayed until Current

Reasons for adding or updating:
Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 11-Mar-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.8 - updated to include hypersensitivity (including rash, itching, angioedema and dyspnoea)

Updated on 23/04/2007 and displayed until 17/03/2011

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: 03/2002
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 9 Addition of missing date

Updated on 23/04/2007 and displayed until 23/04/2007

Reasons for adding or updating:
Change to section 9 - Date of first Authorisation/renewal of the Authorisation Pending awaiting re-submission
Date of revision of text on the SPC: 03/2002
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 9 Addition of missing date

Updated on 20/04/2007 and displayed until 23/04/2007

Reasons for adding or updating:
Change to section 4.3 - Contraindications 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
Date of revision of text on the SPC: 03/2002
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.3 Addition of acne vulgaris to contraindications, and not for use in sore, acute or pustular psoriasis or in the presence of infection Section 4.4 Addition of warning to avoid mucosa, genital or rectal areas and broken or inflamed skin Section 4.8 Addition of skin irritation and acne like eruptions and photosensitivity. Addition of warning may cause allergic reactions (possibly delayed) in certain individuals