Cephalon (UK) Limited

In section 4.4 (Special warnings and precautions for use); addition of the text “Skin irritation has been reported following application of Zacin”

In section 4.8 (Undesirable effects); the addition of “skin irritation” as an adverse event.
 

In section 5.1 (Pharmacodynamic properties); at the start the following wording has been added “Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents, ATC code: M02A B01.”

Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:

Section 7:  Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire

Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0014 to PL 16260/0028      

Section 9: Date of First Authorisation/Renewal of the Authorisation

Section 4.4:
The addition of a warning regarding the inhalation of vapours


Section 4.8:
Updated to add nasal and throat irritation as specific examples of mucous membrane irritation

Section 1 has been amended to include w/w as follows: Zacin 0.025% w/w Cream

Section 4.4 has been updated to add: ‘The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.’

Section 7 - Marketing Authorisation Holder

changed to:

Cephalon Limited

The Magdalen Centre

Oxford Science Park

Oxford

Oxfordshire

OX4 4GA