Lamisil Once 1% cutaneous solution
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 April 2023
File name
working-ie-spc-Lamisil Once-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2023
File name
working-ie-pil-Lamisil Once-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 April 2023
File name
working-ie-spc-Lamisil Once-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 February 2022
File name
IE-SPC-Lamisil Once-approved.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2021
File name
Lamisil Once 1 Cutaneous Solution-PIL-14 January 2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
It was noticed the wrong manufactrurer was on the PIL, needed to update the artwork. Was previously approved in another variation.
Updated on 03 December 2020
File name
Lamisil Once 1 Cutaneous Solution-SPC-2 December 2020.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 not be renewed (A)
Updated on 03 December 2020
File name
Lamisil Once 1 Cutaneous Solution-PIL-2 December 2020.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 23 January 2020
File name
m1-3-LAMISIL ONCE 4G IE PIL 191101IR.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Safety changes to the leaflet
Updated on 23 January 2020
File name
IE-spc-lamisilonce-proposed-clean-191101IR#.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.2
Updated on 20 March 2019
File name
ie-mockup-lamonce-proposed-pl-feb2019.pdf
Reasons for updating
- Removal/change of distributor
Updated on 03 November 2016
File name
PIL_16701_165.pdf
Reasons for updating
- New PIL for new product
Updated on 03 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 November 2016
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 November 2016
Reasons for updating
- Company name change or merger
Updated on 03 October 2016
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:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 29 April 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 25 November 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1
Clarification of indication to specify that it is for adults
Section 4.4
Addition of “after sun exposure or severe skin scaling”
Addition of “sight and” before “reach of children”
Section 4.7
Addtion of “or negligible”
Section 4.8
Headings added and explanation of frequencies
Section 5.1
Addition of heading and paragraph regarding relapse or reinfection.
Section 7
Address amended to Watchmoor Park
Section 10
Date of revision updated from 21 Jan 2013 to 20th November 2015
Updated on 13 February 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2
Addition of “Cutaneous use”
Addition of subheadings
Section 4.3
“terbinafine” replaced with “active substance”
Section 4.4
Add “should be kept out of reach of children” and statement about use in patients with lesions and use on the face.
Information about ethanol content reworded
Section 4.5
Section replaced with “No drug interactions are known with Lamisil Once 1% cutaneous solution.”
Section 4.6
Addition of fertility section
Section 4.7
Sentence reworded
Section 4.9
Section reworded with additional information about accidental oral ingestion and how to treat.
Updated on 09 March 2012
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6
Change to heading from ‘Pregnancy and lactation’ to ‘Fertility, pregnancy and lactation’.
Section 6.1
Deletion of ‘hyprolose’ and addition of ‘hydroxypropylcellulose’.
Section 10
Addition of date 29 July 2011
Updated on 23 July 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)