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Lamisil Once 1% cutaneous solution

*
Pharmacy Only: Non-prescription

  • Company:

    Karo Pharma AB

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Terbinafine Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 10 October 2024

File name

SmPC 20240328 Lamisil once IE.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:Supply through pharmacy only

Updated on 10 October 2024

File name

PL 20240328 Lamisil once IE (3).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical 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:Supply through pharmacy only
 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:Supply through pharmacy only
 Updated on 10 February 2022 
File name
IE-SPC-Lamisil Once-approved.pdf
Reasons for updating
  •  Correction of spelling/typing errors 
Legal category:Supply through pharmacy only
 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:Supply through pharmacy only
 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:Supply through pharmacy only
 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:Supply through pharmacy only
 Updated on 03 November 2016 
Reasons for updating
  •  Correction of spelling/typing errors 
Legal category:Supply through pharmacy only
 Free text change information supplied by the pharmaceutical company 
Correction of typographical errors

 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:Supply through pharmacy only
 Free text change information supplied by the pharmaceutical company 
Sections 7, 8 & 10 updated following Change of Ownership approval

 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:Supply through pharmacy only
 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:Supply through pharmacy only
 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:Supply through pharmacy only
 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:Supply through pharmacy only