Lamisil Once 1% cutaneous solution *

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 22 January 2021

File name

Lamisil Once 1 Cutaneous Solution-PIL-14 January 2021_1611322520.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_1607011874.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_1607011803.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_1579790625.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#_1579790326.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_1553094613.pdf

Reasons for updating

  • Removal/change of distributor

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

Correction of typographical errors

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

  • Company name change or merger

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 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

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: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)