Voltarol Retard 100mg film-coated prolonged-release 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 09 November 2022
File name
Voltarol 75mg & 100mg REG PIL PF21-196 & 22-132 clean V2 IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 08 November 2022
File name
Voltarol 75mg & 100mg 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 75mg & 100mg 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 Retard 100mg 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 sucrose 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 75mg & 100mg 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 Retard 100mg 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 75mg & 100mg REG PIL PF19-119 Sept 2019_TBI 06 March 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 Retard 100mg tablets REG SPC PF19-119 November 2019 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
- 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 06 June 2019
File name
Voltarol Retard 100mg tablets REG SPC PF18-039 May 2019 clean IPHA.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 May 2019
File name
Voltarol 75 & 100mg 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 Retard 100mg 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 21 August 2018
File name
Voltarol 75 & 100mg REG PIL 1230338_1230339 Brexit PF18-159 TBI 29 December 2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 18 July 2018
File name
Voltarol Retard 100mg tablets REG SPC PF18-159 June 2018_clean IPHA.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 November 2016
File name
PIL_15386_584.pdf
Reasons for updating
- New PIL for new product
Updated on 16 November 2016
Reasons for updating
- Change to section 3 - how to take/use
Updated on 25 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 October 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Update Section 4.5: Deletion of the word “isolated” when describing reports of interaction between diclofenac and anticoagulants
Update Section 4.8: Addition of “ischemic colitis” as an adverse reaction with frequency “not known”
Updated on 03 September 2015
Reasons for updating
- Change to further information section
Updated on 28 July 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 March 2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2: A dosage recommendation has been added for special populations (renal and hepatic impaired patients)
Section 4.3: Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease added as contraindications
Section 4.4: Warning that patients with significant risk factors for cardiovascular events should only be treated with diclofenac after careful consideration for the shortest duration possible and at the lowest effective daily dose
Section 4.4: Warning to alert the patients to the signs and symptoms of the serious arteriothrombotic events
Section 4.5: A new interaction between systemic diclofenac containing products and drugs known to cause hyperkalemia has been included
Section 4.8: The frequency of cardiac disorders is changed from very rare to uncommon
Section 4.8: Revision of the adverse drug reactions according to the last MedDRA terms and reporting requirements for suspected adverse events added.
Section 5.3: Addition of nonclinical data regarding the contraindication during the third trimester
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 26 September 2013
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2013
Reasons for updating
- Change of inactive ingredient
- Change to drug interactions
- Change to name of manufacturer
Updated on 12 June 2013
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
· SPC Section 4.3: New contraindication added: Active gastric or intestinal ulcer, bleeding or perforation
· SPC section 4.4: Reworded
· SPC Section 4.5 Updated to include new interactions between systemic diclofenac containing products and potent CYP2C9 inhibitors, colestipol & cholestyramine and phenytoin
· SPC Section 4.6: Addition of information from studies of the effects of diclofenac in pregnancy
· SPC section 4.8: Addition of ulcerative stomatitis as AE
· Section 6.1 Update to reflect change in printing ink used
Updated on 08 May 2013
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 September 2012
Reasons for updating
- 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
Updated on 30 May 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 08 December 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Tablet markings corrected and
inclusion of printing ink constituents
Updated on 25 June 2009
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 June 2008
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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Updated on 17 November 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 October 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 September 2006
Reasons for updating
- Change in co-marketing arrangement
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2006
Reasons for updating
- 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 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)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)