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Adenuric 120 mg film-coated tablets

  • Name:

    Adenuric 120 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    febuxostat

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 8/8/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

Company Products

Medicine NameActive Ingredients
Medicine Name Adenuric 120 mg film-coated tablets Active Ingredients febuxostat
Medicine Name Adenuric 80 mg film-coated tablets Active Ingredients febuxostat
Medicine Name Brimica Genuair 340 micrograms /12 micrograms inhalation powder Active Ingredients Aclidinium Bromide, Formoterol fumarate dihydrate
Medicine Name Drynol 10 mg orodispersible tablets Active Ingredients Bilastine
Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
Medicine Name Eklira Genuair 322 micrograms inhalation powder Active Ingredients Aclidinium Bromide
Medicine Name Fastum 2.5% w/w gel Active Ingredients Ketoprofen
Medicine Name Frovex Active Ingredients Frovatriptan succinate monohydrate
Medicine Name Keral 25 mg granules for oral solution Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 25mg Tablets Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 50 mg/2ml Solution for injection/infusion Active Ingredients Dexketoprofen trometamol
Medicine Name Konverge film-coated tablets Active Ingredients Amlodipine besilate, olmesartan medoxomil
Medicine Name Konverge Plus film-coated tablets Active Ingredients Amlodipine besilate, Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Nebilet Active Ingredients Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Omesar 10mg, 20mg and 40mg Film-Coated Tablets Active Ingredients olmesartan medoxomil
Medicine Name Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Osteofos D3 Active Ingredients Calcium phosphate, Colecalciferol (Vitamin D3)
Medicine Name Priligy 30 mg and 60 mg film-coated tablets Active Ingredients Dapoxetine hydrochloride
Medicine Name Quofenix 300 mg powder for concentrate for solution for infusion Active Ingredients Delafloxacin Meglumine
Medicine Name Quofenix 450 mg tablets Active Ingredients Delafloxacin Meglumine
Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
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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 8 August 2019 PIL

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 8 August 2019 SPC

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 1 August 2019 SPC

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

Updated on 5 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 10 January 2019 PIL

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 SPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 6 April 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 6 April 2018 SPC

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 9 March 2017 PIL

Reasons for updating

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

Updated on 9 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 January 2017 SPC

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 PIL

Reasons for updating

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

Updated on 24 January 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 2 February 2016 SPC

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 2 February 2016 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 7 May 2015 SPC

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 7 May 2015 PIL

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 PIL

Reasons for updating

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

Updated on 6 February 2014 PIL

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 PIL

Reasons for updating

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

Updated on 1 November 2012 PIL

Reasons for updating

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

Updated on 27 January 2012 PIL

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 PIL

Reasons for updating

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

Updated on 2 February 2011 PIL

Reasons for updating

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

Updated on 16 September 2010 PIL

Reasons for updating

  • Change to drug interactions

Updated on 28 May 2010 PIL

Reasons for updating

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

Updated on 11 March 2010 PIL

Reasons for updating

  • New PIL for new product