Voltarol 50mg Gastro-resistant tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 November 2022
File name
Voltarol 50mg REG PIL PF21-196 & 22-132 clean V2 IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 05 October 2022
File name
Voltarol 50mg REG PIL PF21-196 & 22-132 clean IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Changes to recommendation on use during pregnancy, particularly after week 20
Updated on 05 October 2022
File name
Voltarol 50 mg tablets REG SPC PF21-196 & 22-132_30.09.22_clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: Editorial changes to lactose warning
Section 4.8: Inclusion of wording describing the risk of oligohydramnios and ductus arteriosus constriction in pregnancy after week 20.
Updated on 11 February 2021
File name
Voltarol 50mg REG PIL PF20-174 clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Addition of following text: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Updated on 11 February 2021
File name
Voltarol 50 mg tablets REG SPC PF20-174 October 2020 clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following statement has been added to Section 4.4: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free '.
Updated on 18 November 2019
File name
Voltarol 50mg REG PIL PF19-119 Sept 2019 TBI 06-Mar-2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 18 November 2019
File name
Voltarol 50 mg tablets REG SPC PF19-119 November 2019 IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.4: Addition of wording regarding increased risk of gastro-intestinal anastomotic leak associated with NSAID use
- Section 4.4: Addition of wording regarding hypersensitivity reactions progressing to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction
Updated on 20 May 2019
File name
Voltarol 50mg REG PIL PF18-039 TBI 2 Nov 2019_clean IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
Updated on 20 May 2019
File name
Voltarol 50 mg tablets REG SPC PF18-039 May 2019 clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 has been updated to include the following text “CYP2C9 inducers: Caution is recommended when co-prescribing diclofenac with CYP2C9 inducers (such as rifampicin), which could result in a significant decrease in plasma concentration and exposure to diclofenac”.
Section 4.8 has been updated the include “Kounis syndrome” with a Frequency “Not known”
Updated on 22 August 2018
File name
Voltarol 50mg REG PIL 1815645 P18-160 TBI 29 December 2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 18 July 2018
File name
Voltarol 50 mg tablets REG SPC June 2018 PF18-160 clean IPHA.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 November 2016
File name
PIL_8544_834.pdf
Reasons for updating
- New PIL for new product
Updated on 29 November 2016
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 18 March 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
Updated on 23 August 2013
Reasons for updating
- Change to drug interactions
- Change due to user-testing of patient information
Updated on 30 May 2012
Reasons for updating
- Change to name of manufacturer
Updated on 25 June 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 06 November 2006
Reasons for updating
- Change to appearance of the medicine
Updated on 17 May 2005
Reasons for updating
- Change to date of revision
Updated on 26 August 2004
Reasons for updating
- New PIL for medicines.ie