Salatac Gel
*Company:
Dermal Laboratories (Ireland) LtdStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 September 2025
File name
IE SALG-IPHA-PIL WP10-25-1.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 18 September 2025
File name
IE SPC SALG IPHA 082025.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 4.6 Fertility, pregnancy and lactation, revised wording
There are no or limited amount of data from the use of Salatac Gel during pregnancy.
Salatac Gel should not be used during pregnancy, except for short-term treatment of a small single wart, verruca, corn or callus.
It is not known if the systemic Salatac Gel exposure reached after topical administration can be harmful to an embryo/fetus.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed.
Section 10 Date of Revision of the text
“July 2025”
Updated on 14 July 2025
File name
SALG-IPHA-PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6 change of Manufacturer from Aeropak to Jenson R+
Section 6 update to revision date December 2024
Updated on 26 November 2024
File name
SALG-IPHA-PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- 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
Section 5 store remove on the fold and add at the end
Section 6 Marketing Authorisation delete UK details
Section 6 leaflet revised September 2024
Updated on 26 November 2024
File name
SALG-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
SALG-IPHA.SPC.pdf
Reasons for updating
- Document format updated
Legal category:Supply through pharmacy only
Updated on 17 December 2020
File name
SALG-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 17 December 2020
File name
EXTL-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
SALG-IPHA.SPC.12.05.15.18.05.15.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 18 May 2015
File name
PIL_8670_54.pdf
Reasons for updating
- New PIL for new product
Updated on 18 May 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 18 May 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
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 "April 2015"
Updated on 18 May 2015
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- 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 18 February 2010
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
In section 10 (Date of revision of the text) - the date has changed to "November 2009"
Updated on 30 November 2009
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 16 May 2005
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
Updated on 20 January 2005
Reasons for updating
- Improved electronic presentation
Updated on 07 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 12 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Dermal Laboratories (Ireland) Ltd
Address:
Dermal Laboratories (Ireland) Ltd, 38 Main Street, Swords, Co Dublin, K67 E0A2, IrelandMedical Information E-mail:
info@dermal.ie