Lamisil Once 1% cutaneous solution
- Name:
Lamisil Once 1% cutaneous solution
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/01/21
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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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 PIL
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 3 December 2020 SPC
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 3 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 23 January 2020 PIL
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 SPC
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 PIL
Reasons for updating
- Removal/change of distributor
Updated on 3 November 2016 SPC
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 3 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 3 November 2016 PIL
Reasons for updating
- Company name change or merger
Updated on 3 November 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 October 2016 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 25 November 2015 SPC
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 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 4.5 - 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 9 March 2012 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)