Lamisil 1% w/w Cream *

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 29 March 2021

File name

ie-spc-Lamisil 1 cream-approved_1617042184.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 be renewed (B)

Updated on 29 March 2021

File name

Approved LAMISIL_1530_g_Leaflet lamisil 1 cream_1617042045.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 31 July 2019

File name

LAM CRM IE PIL Aug 18_1564415400.pdf

Reasons for updating

  • Change to date of revision

Updated on 03 November 2016

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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MA details updated following Change of Ownership approval

Updated on 03 November 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 November 2016

File name

PIL_16699_4.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 November 2016

Reasons for updating

  • Company name change or merger

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:Product subject to medical prescription which may be renewed (B)

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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7

 

Address changed from Horsham to Camberley

 

Section 10

 

Date of revision changed from 25th July 2013 to 25th June 2014

Updated on 06 August 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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Section 4.2

Duration and frequency of application noted as being specific to each indication and clarified.

 

Information relating to dosing in children combined with dosing in the elderly under subheading “Dosing in special populations”

 

All instructions relating to method of administration moved under new subheading “method of administration”

 

“For cutaneous use” added,

 

Section 4.3

 

Location of excipient list added

 

Section 4.4

 

Added further warnings regarding contact with eyes, including likely symptoms and how to manage.

 

Inclusion of warning relating to skin reactions associated with cetyl alcohol and stearyl alcohol.

 

Section 4.6

 

“unless clearly necessary” added for use in pregnancy

 

Information regarding animal studies included in pregnancy and fertility sections.

 

Warning advising that infants should not come into contact with treated skin, under breastfeeding heading.

 

“Pregnancy”, “Breastfeeding” and “Fertility” subheadings added

 

Section 4.7

 

“Lamisil Cream has no influence on the ability to drive and use machines.” added

 

Section 4.8

 

Information expanded to include:

- frequency of adverse events,

- clarification of types of skin reactions that may be expected (pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur)

- need to distinguish between minor skin reactions and hypersensitivity reactions and subsequent need for discontinuation.

- potential irritation on the occasion of contact with the eyes

- aggravation of underlying fungal infection

 

Section 4.9

 

Section expanded to include:

- Likelihood of overdose

- Information related to accidental ingestion and likely side effects

- Treatment for accidental ingestion

 

Section 5.1

 

Pharmacotherapeutic group added

 

Addition of types of fungal and yeast infections susceptible to terbinafine.

 

Information relating to duration of action and relapse/re-infection rate added.

 

Information previously under section 5.2 (“Terbinafine…other drugs”) moved to section 5.1

 

Section 5.2

 

Pharmacokinetic information added – all new information

 

Section 5.3

 

Information expanded with relevant preclinical data.

 

Section 10

 

Date of revision updated to 25 July 2013

Updated on 24 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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 9: Updated renewal of authorisation

Section 10: Revision date changed

 

Updated on 11 July 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: Trade name updated to include 1%

Section 2: Addition of “for excipients see 6.1” and removal of “white cream”

Section 3: Addition of “white, smooth or almost smooth, glossy cream”

Section 6.2: Text revised from “None” to “Not applicable”

Section 6.4: Text revised from “none” to “this medicinal product does not require any special storage conditions”

Section 6.6: Text revised from “None” to “no special requirements”

Section 9: Updated renewal of authorisation

Section 10: Revision date changed

Updated on 07 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)