Lamisil AT Cream
- Name:
Lamisil AT Cream
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/07/19


Print ViewKeyword Search SPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
 Ltd.jpg)
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 23 July 2019 PIL
Reasons for updating
- Change to date of revision
Updated on 2 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 2 November 2016 PIL
Reasons for updating
- Company name change or merger
Updated on 3 October 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 3 October 2016 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 29 April 2016 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 22 September 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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 1st Sept 2015
Updated on 3 July 2014 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Address changed from Horsham to Camberley
Section 10
Date of revision changed from 31st October 2013 to 25th June 2014
Updated on 3 December 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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
Updated on 23 March 2009 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 9: Updated renewal of authorisation
Section 10: Revision date changed
Updated on 23 July 2008 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 6.3: Insertion of polypropylene dispenser shelf life.
Section 6.5: Insertion of polypropylene dispenser container details
Updated on 7 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only