Voltarol Emulgel Extra Strength 2% w/w Gel
*Company:
Haleon Ireland LimitedStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 April 2024
File name
ie-text-pl-voltarol-emulgel-extra-clean-240408KK-April 2024.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
Updated due to the deletion of GSK CH Munich as a Batch Release Site.
Updated on 18 July 2023
File name
ie-spc-Voltarol-proposed-clean-Jun2023.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Updated on 18 July 2023
File name
ie-pl-Voltarol-proposed-clean-Jun2023.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 08 April 2022
File name
ie-spc-voltarolemulgelextrastrength-proposed-clean-GDSv5 220228GLH.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Change to Section 4.4 - Special warnings and precautions for use.
This change is to add the flammability warning to the SPC, instructing patients not to smoke or go near naked flames for risk of severe burns.
Updated on 15 July 2021
File name
PA3718_VOLTAROL_EX STRENGTH_Leaflet Mock-up_medicines ie.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changing the header “ Driving and using machines” to “Driving and Using Machines”
Section 3: Changing “…Do not apply a double quantity to make up for a forgotten application” to “Do not apply a double quantity to make up for the forgotten application.”
Section 5: Changing “…The expiry date refers to the last day of the month.” To “The expiry date refers to the last day of that month.”
Changing the header “Marketing authorisation holder” to “Marketing Authorisation Holder”
Changing the date of revision from “June 2020” to “August 2020”
Updated on 15 September 2020
File name
ie-spc-voltarolemulgelextrastrength-proposed-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Supply through pharmacy only
Updated on 17 August 2020
File name
ie-text-pl-voltarol-emulgel-extra-GRACE-proposed-clean-Jul-20 For medicines.ie2.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Update to section 3 of the PIL to include flip-top cap.
Updated on 17 August 2020
File name
ie-spc-voltarolemulgelextrastrength-clean-200402SKDJ.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Updated on 08 June 2020
File name
ie-spc-clean-PA0678140003-April 2020x.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update to the SPC following the approval of a safety variation.
Updated on 08 June 2020
File name
ie-mockup-leaflet-volt-emulgel-extra-proposed-clean-mar2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to the leaflet following the approval of a saftey variation.
Updated on 02 April 2020
File name
ie-spc-voltarenemulge2p-clean-proposed-feb2020.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Update to section 4.2 to increase the duration of use to 14 days.
To add 100g as a pack size to section 6.5.
Updated on 25 March 2019
File name
ie-mockup-pl-voltarolgel2p-proposed-jan2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 October 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 26 October 2017
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 27 October 2016
File name
PIL_16711_522.pdf
Reasons for updating
- New PIL for new product
Updated on 27 October 2016
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 06 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
Updated on 03 May 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 05 April 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only