Adenuric 80 mg film-coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal 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 20 September 2022
File name
Adenuric PIL UK-IE Clean Aug 22.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Hungarian local rep phone number updated
Section 6 - date of revision updated
Updated on 27 January 2022
File name
Adenuric 80 mg SmPC IE clean Approved Dec 2021.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
Section 4.4 - Information from post authorisation study (FAST) added and sodium content warning added
Section 4.8 - Adverse events updated
Section 5.1 - FAST study information added
Section 10 - Date of revision updated
Updated on 27 January 2022
File name
Adenuric PIL UK-IE Clean Approved Dec 2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Sodium content warning added
Section 4 - Side effects updated
Section 6 - Obsolete manufacturer details removed
Section 6 - Date of revision updated
Updated on 08 August 2019
File name
Adenuric PIL UK-IE clean 31-7-19.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 80 mg SmPC IE clean 31-7-19.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 10 January 2019
File name
Adenuric PIL UK-IE clean 29-10-18.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 10 January 2019
File name
Adenuric 80 mg SmPC IE clean 29-10-18.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
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
File name
Adenuric 80 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
Adenuric PIL UK-IE clean 31-5-18.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
File name
PIL_14608_22.pdf
Reasons for updating
- New PIL for new product
Updated on 09 March 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
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 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 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
- 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
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 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
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 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 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 15 January 2013
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
Updated on 11 January 2013
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 08 November 2012
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 01 November 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 02 February 2012
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
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 10 May 2011
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 07 February 2011
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 02 February 2011
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 23 September 2010
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
Reasons for updating
- Change to drug interactions
Updated on 11 June 2010
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
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 11 March 2010
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
Updated on 11 March 2010
Reasons for updating
- New PIL for new product