Voltarol 50mg Gastro-resistant tablets

  • Name:

    Voltarol 50mg Gastro-resistant tablets

  • Company:
    info
  • Active Ingredients:

    Diclofenac Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/19

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Summary of Product Characteristics last updated on medicines.ie: 18/11/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
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1 - 0 of 114 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 November 2019 PIL

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 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 July 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 2016 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 18 March 2014 PIL

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 PIL

Reasons for updating

  • Change to drug interactions
  • Change due to user-testing of patient information

Updated on 30 May 2012 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 25 June 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 6 November 2006 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 17 May 2005 PIL

Reasons for updating

  • Change to date of revision

Updated on 26 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie