Lamisil 1% w/w Cream
- Name:
Lamisil 1% w/w Cream
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/07/19


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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
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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 31 July 2019 PIL
Reasons for updating
- Change to date of revision
Updated on 3 November 2016 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 3 November 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 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: Product subject to medical prescription which may be renewed (B)
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: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7
Address changed from Horsham to Camberley
Section 10
Date of revision changed from 25th July 2013 to 25th June 2014
Updated on 6 August 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: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
Updated on 24 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: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 9: Updated renewal of authorisation
Section 10: Revision date changed
Updated on 11 July 2008 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
Updated on 7 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)