Voltarol Retard 100mg film-coated prolonged-release tablets.

*
Pharmacy Only: Prescription
  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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

Change IMB to HPRA

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

Inclusion of the limited clinical trial experience of the use of diclofenac in Juvenile Rheumatoid Arthritis (JRA)/Juvenile Idiopathic Arthritis (JIA) paediatric patients

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

Section 6.1 updated with description of new printing ink

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

Hepatic necrosis and hepatic failure added

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

Include film-coated prolonged release in the name
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

Section 3 Pharmaceutical form - Typographical error has been corrected

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

Changes to Sections 4.2,4.3,4.4,4.5,4.8

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

The changes follow a BPI update

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

 
 
The SPC update follows a BPI update.

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

 
 
 
change of manufacturer

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)