Adenuric 120 mg film-coated tablets *

  • Company:

    A. Menarini Pharmaceuticals Ireland Ltd
  • 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

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 08 August 2019

File name

Adenuric PIL UK-IE clean 31-7-19_1565259933.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 08 August 2019

File name

Adenuric 120 mg SmPC IE clean 31-7-19_1565259882.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Additional information from the CARES study is included in the SmPC.

 The following sections of the SmPC are updated:

-        Section 4.4 Warnings and precautions - rewording of the warning for patients with pre-existing CV disease

-        Section 4.8 Undesirable effects - addition of the ADR 'Sudden Cardiac Death' with rare frequency

-        Section 5.1 Pharmacodynamic properties - inclusion of information on the CARES study.

Updated on 01 August 2019

File name

Adenuric 120 mg SmPC IE clean 31-5-18_1564649759.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to pdf

EDM Updated on 05 July 2019

File name

A.Menarini letter scan of final letter gone out_1562244012.pdf

Reasons for updating

  • Add New Doc

Updated on 10 January 2019

File name

Adenuric PIL UK-IE clean 29-10-18_1547118825.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 12 July 2018

File name

Adenuric 120 mg SmPC IE clean 31-5-18.docx

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 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

Update of sections 4.4, 4.5 and 5.3 of the SmPC following the conclusion of a preclinical and a clinical study investigating the drug-drug interaction between azathioprine / 6-mercaptopurine and febuxostat.

 

Updated on 12 July 2018

File name

PIL_14608_22.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 06 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 06 April 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

Add “agranulocytosis” as a rare adverse reaction coming from post-marketing experience.

Updated on 09 March 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 09 March 2017

File name

PIL_14608_22.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 January 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.8     Undesirable effects

Add “blood creatine phosphokinase increase” under Investigations as a rare adverse reaction coming from post-marketing experience.

Updated on 24 January 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 02 February 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The following sections have been updated:

Section 4.2      Posology and method of administration

 

         ‘Older people’ changed to ‘Elderly’

 

6.5     Nature and contents of container

 

         New packaging material added - PVC/PE/PVDC/Aluminium for blisters.

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

         New Marketing Authorisation numbers added.

 

10.     DATE OF REVISION OF THE TEXT

 

         Updated to 21 December 2015

Updated on 02 February 2016

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 07 May 2015

Reasons for updating

  • New individual SPC (was previously included in joint SPC)

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

Free text change information supplied by the pharmaceutical company

Adenuric 120 mg film-coated tablet updates:

4.1 Therapeutic indications

New indication added: ADENURIC is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).

4.2 Posology and method of administration

Updated for TLS dosing.

4.4 Special warnings and precautions for use

Updated to include prevention and treatment of hyperuricaemia in patients at risk of TLS.

Xanthine deposition - paragraph updated to add not observed during the pivotal clinical study for TLS.

4.5 Interaction with other medicinal products and other forms of interaction

Paragraph on drug interaction studies of febuxostat with cytotoxic chemotherapy updated to add not explored during the pivotal clinical study for TLS.

4.8 Undesirable effects

Summary of the safety profile for TLS and side-effects information added – uncommon: left bundle branch block, sinus tachycardia, haemorrhage.

5.1 Pharmacodynamic properties

Information on the TLS study added.

Updated on 07 May 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 25 March 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 06 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 11 January 2013

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 01 November 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 27 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 12 May 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 02 February 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 16 September 2010

Reasons for updating

  • Change to drug interactions

Updated on 28 May 2010

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 11 March 2010

Reasons for updating

  • New PIL for new product