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 25^th July 2013 to 25^th June 2014

Duration and frequency of application noted as being specific to each indication and clarified.

Information relating to dosing in children combined with dosing in the elderly under subheading “Dosing in special populations”

All instructions relating to method of administration moved under new subheading “method of administration”

“For cutaneous use” added,

Section 4.3

Location of excipient list added

Section 4.4

Added further warnings regarding contact with eyes, including likely symptoms and how to manage.

Inclusion of warning relating to skin reactions associated with cetyl alcohol and stearyl alcohol.

Section 4.6

“unless clearly necessary” added for use in pregnancy

Information regarding animal studies included in pregnancy and fertility sections.

Warning advising that infants should not come into contact with treated skin, under breastfeeding heading.

“Pregnancy”, “Breastfeeding” and “Fertility” subheadings added

Section 4.7

“Lamisil Cream has no influence on the ability to drive and use machines.” added

Section 4.8

Information expanded to include:

- frequency of adverse events,

- clarification of types of skin reactions that may be expected (pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur)

- need to distinguish between minor skin reactions and hypersensitivity reactions and subsequent need for discontinuation.

- potential irritation on the occasion of contact with the eyes

- aggravation of underlying fungal infection

Section 4.9

Section expanded to include:

- Likelihood of overdose

- Information related to accidental ingestion and likely side effects

- Treatment for accidental ingestion

Section 5.1

Pharmacotherapeutic group added

Addition of types of fungal and yeast infections susceptible to terbinafine.

Information relating to duration of action and relapse/re-infection rate added.

Information previously under section 5.2 (“Terbinafine…other drugs”) moved to section 5.1

Section 5.2

Pharmacokinetic information added – all new information

Section 5.3

Information expanded with relevant preclinical data.

Section 10

Date of revision updated to 25 July 2013

Section 9: Updated renewal of authorisation

Section 10: Revision date changed

Section 1: Trade name updated to include 1%

Section 2: Addition of “for excipients see 6.1” and removal of “white cream”

Section 3: Addition of “white, smooth or almost smooth, glossy cream”

Section 6.2: Text revised from “None” to “Not applicable”

Section 6.4: Text revised from “none” to “this medicinal product does not require any special storage conditions”

Section 6.6: Text revised from “None” to “no special requirements”

Section 9: Updated renewal of authorisation

Section 10: Revision date changed