Lamisil 1% w/w Cream
*Company:
Karo Pharma ABStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 October 2024
File name
SmPC 20240328 Lamisil cream IE (2).pdf
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)
Updated on 10 October 2024
File name
SmPC 20240328 Lamisil cream IE (2).pdf
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)
Updated on 10 October 2024
File name
PL 20240328 Lamisil cream IE (5).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to date of revision
Updated on 12 July 2023
File name
ie-spc-Lamisil 1% cream-separation-clean-230630RE.pdf
Reasons for updating
- 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)
Updated on 12 July 2023
File name
ie-pil-lamisil 1% cream-15g-30g-separation-clean-230630RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 March 2021
File name
ie-spc-Lamisil 1 cream-approved.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 March 2021
File name
Approved LAMISIL_1530_g_Leaflet lamisil 1 cream.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 31 July 2019
File name
LAM CRM IE PIL Aug 18.pdf
Reasons for updating
- Change to date of revision
Updated on 03 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 November 2016
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 02 November 2016
File name
PIL_16699_4.pdf
Reasons for updating
- New PIL for new product
Updated on 02 November 2016
Reasons for updating
- Company name change or merger
Updated on 29 April 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 22 September 2015
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 03 July 2014
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 06 August 2013
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
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
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 07 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)