Login

Salactol Collodion

*
Pharmacy Only: Non-prescription

Updated on 26 November 2024

File name

SLTL-IPHA-PIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4 revised wording remove yellow card details add Via HPRA Pharmacovigilance website, add Via HPRA Pharmacovigilance website WWW.hpra.ie

Section 6 Marketing Authorisation delete UK details

Section 6 leaflet revised September 2024

Updated on 26 November 2024

File name

SLTL-IPHA-SPC.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

In Section 4.8 Undesirable effects 

 

The following text has been revised :

 

After Pharmacovigilance, IR address deleted and email removed

 

In Section 10 Date of revision of the text:

 

The date has changed to:

“November 2024”

Updated on 23 January 2023

File name

SLTL-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Updated on 17 December 2020

File name

SLTL-IPHA.SPC.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 31 August 2018

File name

SLTL-IPHA.SPC.07.07.15.10.07.15.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 10 July 2015

File name

PIL_8667_951.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 10 July 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "June 2015"

Updated on 10 July 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 25 July 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 20 June 2011

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

In section 6.5 (Nature and contents of container) the text has changed to include "with a plastic screw cap"

In section 10 (Date of revision of the text) the date has changed to "June 2011"

Updated on 25 June 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 29 August 2007

Reasons for updating

  • Change of trade or active ingredient name
  • Change to further information section

Updated on 13 August 2007

Reasons for updating

  • 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 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.

Updated on 18 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 - Name of the medicinal product: Changed to "SALACTOL COLLODION"
 
Section 4.2 - Posology and method of administration: Text deleted "There are no differences in the recommended dosages for children, adults and the elderly."
 
Additional text added.
 
Text amended to read "Using the applicator provided, carefully apply a few drops of Salactol to the lesion allowing each drop to dry before applying the next one." "Repeat the procedure daily, after first removing any plaster."
 
Section 4.3 - Contraindications: Text amended to read "Not to be used on or near the face, intertriginous or anogenital regions."
"Not to be used on moles, birthmarks, hairy warts or any other skin lesions for which it is not indicated."
 
Section 4.4 - Special warnings and precautions for use: Text amended to read "The paint should be applied carefully to the wart, verruca, corn or callus only, to avoid possible irritation of surrounding normal skin."
 
Section 6.4 - Special precautions for storage: Text deleted "Store upright and away from flames."
 
Section 6.5 - Nature and contents of container: Text deleted "for ease of application."
 
Section 9 - Renewal of the Authorisation: Changed to "19 February 2006"
 
Section 10 - Date of revision of the text: Changed to "June 2006"

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only