Adenuric 80 mg film-coated tablets

  • Name:

    Adenuric 80 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
1 - 0 of 31 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 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

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

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 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 10 January 2019

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Update to section 3:

Film-coated tablet (tablet).

Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side and a score line on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Updated on 12 July 2018

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

Reasons for updating

  • New SmPC 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

  • New PIL for new product

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 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

  • 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

  • New SmPC 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

  • Change to separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

Change to separate SmPC for Adenuric 80 mg film-coated tablets

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 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 main changes are as follows:

 

Section 4.2 Posology and method of administration

 

Replace ‘elderly’ with ‘older people’

 

Section 4.4      Special warnings and precautions for use

 

Information on interaction with theophylline updated:

 

Theophylline

Co-administration of febuxostat 80 mg and theophylline 400mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5). Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels. No data is available for febuxostat 120 mg.


Section 4.5      Interaction with other medicinal products and other forms of interaction

 

New interaction for Rosiglitazone/CYP2C8 substrates added:

 

Rosiglitazone/CYP2C8 substrates

Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro. In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo. Thus, co‑administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.

 

Information on interaction with theophylline updated:

 

Theophylline

An interaction study in healthy subjects has been performed with febuxostat to evaluate whether the inhibition of XO may cause an increase in the theophylline circulating levels as reported with other XO inhibitors. The results of the study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline. Therefore no special caution is advised when febuxostat 80 mg and theophylline are given concomitantly. No data is available for febuxostat 120 mg.


Section 4.8      Undesirable effects

 

Details for reporting of suspected adverse reactions information added

 

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 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 10 - Date of revision of the text

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

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 15 January 2013 SPC

Reasons for updating

  • 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

Fomatting changes only (including correcting spelling/typing errors) following renewal of the Marketing Authorisation.

Updated on 11 January 2013 PIL

Reasons for updating

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

Updated on 8 November 2012 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 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 4.4 Special warnings and precautions for use:
to update the warning regarding mercaptopurine/azathioprine and use with febuxostat.

Section 4.5 Interaction with other medicinal products and other forms of interaction:
to update the information regarding mercaptopurine/azathioprine and use with febuxostat.

Section 4.8 Undesirable effects: 
to add 2 new rare side-effects - angioedema and rhabdomyolysis.

Updated on 1 November 2012 PIL

Reasons for updating

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

Updated on 2 February 2012 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 to add a warning and to update the safety information in section 4.8 regarding serious hypersensitivity reactions, including Stevens-Johnson syndrome and acute anaphylactic reaction. 

Section 4.8 inclusion in the adverse reactions table drug hypersensitivity, rash generalized, tubulointerstitial nephritis, hepatitis, jaundice, blurred vision and thrombocytopenia.

Section 4.7 blurred vision added.

 

Other sections of the SmPC have also been updated to amend typographical errors and to bring the SmPC into line with the latest guideline and template.

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 10 May 2011 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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 4.8 - Undesirable effects - remove the asterisked information for rashes - ** No serious rashes or severe hypersensitivity reactions were noted in the clinical studies.  

Add new paragraph:

Adverse reactions from spontaneous reporting

There have been post-marketing reports of rare serious rashes, generalised skin rashes and severe hypersensitivity reactions. In most cases, these reactions occurred during the first month of therapy with febuxostat. Some of these patients, but not all, reported previous hypersensitivity to allopurinol.

Section 10 - amend date of revision of the text

Updated on 7 February 2011 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

Section 4.4 Special warnings and precautions for use 
Acute gouty attacks - add cross-reference to sections 4.2, 4.8 and 5.1 where appropriate.  Update information on liver disorders re liver function test abnormalities observed in phase 3 clinical studies.


Section 4.8 Undesirable effects 
Update information regarding number of patients treated in combined Phase 3 studies.  Add extensive new information regarding side-effects seen in the studies.


Section 5.1 Pharmacodynamic properties 
Clinical studies results - update the information to include data from the CONFIRMS study as well as additional information on clinical outcomes for the APEX and
FACT studies.  Also, new information on long term open label extension studies (EXCEL and FOCUS studies).

 

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 23 September 2010 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • 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

  • Section 4.5 - amendment to the wording regarding the interaction for warfarin.

    No dose adjustment is necessary for warfarin when administered with febuxostat. Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects. INR and Factor VII activity were also not affected by the co-administration of febuxostat.  After initiation of febuxostat therapy, monitoring of anticoagulant activity should be considered in patients receiving warfarin or similar agents.
  • Section 10 - amend date of revision of the text
  • Correction of spelling errors.

 

Updated on 16 September 2010 PIL

Reasons for updating

  • Change to drug interactions

Updated on 11 June 2010 SPC

Reasons for updating

  • 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

Section 6.5 Nature and contents of container - Add new pack sizes - 14, 42, 56 and 98 tablets

Section 8 MA numbers - Add new Marketing Authorisation Numbers

Section 10 - amend date of revision of the text to 23 April 2010

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 SPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 March 2010 PIL

Reasons for updating

  • New PIL for new product