Lamisil AT Cream

Sections 7, 8 & 10 updated following Change of Ownership approval

Section 4.8

AE reporting section added

Section 6.3

Laminated tube added and shelf life reduced for aluminium tube to 3 years

Section 6.4

Storage recommendations changed to store below 30

Section 6.5

Laminated tube information added

Section 6.6

Change of section heading

Section 10

Date of revision changed to 1^st Sept 2015

Section 7

Address changed from Horsham to Camberley

Section 10

Date of revision changed from 31st October 2013 to 25th June 2014



Section 4.2

Information for method of administration moved to end of section.

Additional subheadings added for Duration and frequency of treatment, use in special populations, and rewording for other subheadings.

Twice daily application removed and duration of use aligned for tinea pedis and tinea cruris.

Section 4.3

“listed in section 6.1” added

Section 4.4

Section expanded to include: caution in patients with lesions; potential irritation of eyes and management if contact with eyes occurs; statement about excipients cetyl alcohol and stearyl alcohol; and that product should not be used on the face.

Section 4.6

Section heading – “Fertility” added

Subheadings added.

Under “pregnancy”: “Therefore, unless the potential benefits outweigh any potential risks” removed and “unless clearly necessary” added at the end of section. Direction to section 5.3 added.

Fertility section added.

Section 4.7

“Not known” replaced with “Lamisil AT Cream has no influence on the ability to drive and use machines.”

Section 4.8

Section expanded to include more detailed information about types of side effects that can be expected.

Specific local symptoms provided for application site conditions and clarification of potential hypersensitivity symptoms. Adverse reaction frequency classifications also added and side effects categorised according to frequency.

Section 4.9

Section expanded to provide: more specific information about likelihood of overdose; comparability of quantity of terbinafine following ingestion of topical Lamisil versus oral dose; likely symptoms that may occur if topical Lamisil is ingested; and how overdose should be managed.

Section 5.1

Pharmacotherapeutic group added

Added “in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum” and

“The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.”

Section 5.2

Information added about concentrations of terbinafine in skin after treatment cessation.

Section 5.3

“There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.” replaced with preclinical safety data.

Section 10

3 November 2008 changed to 31 October 2013

 

Section 9: Updated renewal of authorisation

Section 10: Revision date changed

 

Section 6.3: Insertion of polypropylene dispenser shelf life.

Section 6.5: Insertion of polypropylene dispenser container details