Adenuric 120 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 20 September 2022
File name
Adenuric 120 mg SmPC IE Clean Aug 22.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 5.1 - Administrative amends
Section 10 - date of revision updated
Updated on 27 January 2022
File name
Adenuric 120 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 120 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 01 August 2019
File name
Adenuric 120 mg SmPC IE clean 31-5-18.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
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 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
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
- 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