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Lamisil AT Cream

*
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

PL 20240328 Lamisil AT cream IE (4).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

Updated on 10 October 2024

File name

SmPC 20240328 Lamisil AT cream IE (1).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 12 July 2023

File name

ie-spc-lamisil AT 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:Supply through pharmacy only

Updated on 12 July 2023

File name

ie-pil-lamisil AT cream-7.5g-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 AT 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:Supply through pharmacy only

Updated on 29 March 2021

File name

Approved LAMISIL 7.5_g_Leaflet Lamisil AT cream.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 23 July 2019

File name

LAM AT CRM PIL Nov 18.pdf

Reasons for updating

  • Change to date of revision

Updated on 02 November 2016

File name

PIL_16700_868.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 November 2016

Reasons for updating

  • Company name change or merger

Updated on 03 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

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 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:Supply through pharmacy only

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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Address changed from Horsham to Camberley

Section 10

Date of revision changed from 31st October 2013 to 25th June 2014

Updated on 03 December 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company



Section 4.2

Information for method of administration moved to end of section.

Additional subheadings added for Duration and frequency of treatment, use in special populations, and rewording for other subheadings.

Twice daily application removed and duration of use aligned for tinea pedis and tinea cruris.

Section 4.3

“listed in section 6.1” added

Section 4.4

Section expanded to include: caution in patients with lesions; potential irritation of eyes and management if contact with eyes occurs; statement about excipients cetyl alcohol and stearyl alcohol; and that product should not be used on the face.

Section 4.6

Section heading – “Fertility” added

Subheadings added.

Under “pregnancy”: “Therefore, unless the potential benefits outweigh any potential risks” removed and “unless clearly necessary” added at the end of section. Direction to section 5.3 added.

Fertility section added.

Section 4.7

“Not known” replaced with “Lamisil AT Cream has no influence on the ability to drive and use machines.”

Section 4.8

Section expanded to include more detailed information about types of side effects that can be expected.

Specific local symptoms provided for application site conditions and clarification of potential hypersensitivity symptoms. Adverse reaction frequency classifications also added and side effects categorised according to frequency.

Section 4.9

Section expanded to provide: more specific information about likelihood of overdose; comparability of quantity of terbinafine following ingestion of topical Lamisil versus oral dose; likely symptoms that may occur if topical Lamisil is ingested; and how overdose should be managed.

Section 5.1

Pharmacotherapeutic group added

Added “in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum” and

“The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.”

Section 5.2

Information added about concentrations of terbinafine in skin after treatment cessation.

Section 5.3

“There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.” replaced with preclinical safety data.

Section 10

3 November 2008 changed to 31 October 2013

Updated on 23 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Section 9: Updated renewal of authorisation

Section 10: Revision date changed

 

Updated on 23 July 2008

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.3: Insertion of polypropylene dispenser shelf life.

Section 6.5: Insertion of polypropylene dispenser container details

Updated on 07 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only