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Genzyme Therapeutics
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Telephone: +44 (0)1865 405 200
Fax: +44 (0)1865 774 172
WWW: http://www.genzyme.co.uk
Medical Information Direct Line: +44 (0)1483 505 515
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Customer Care direct line: +44 (0)1865 405 200
Medical Information Fax: +44(0)1483 554 805

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/08/2011
SPC Fludara oral 10 mg film-coated tablet

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/08/2011 and displayed until Current
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   10-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 27/05/2011 and displayed until 23/08/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   08-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section   6.4       Special precautions for storage - Additon of the word "storage".
Updated on 12/04/2011 and displayed until 27/05/2011
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   08-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 9 - Correction of dates
Updated on 01/04/2011 and displayed until 12/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantified excipient, lactose monohydrate 74.75 mg

4.2 Posology and method of administration
• Addition of sub heading ‘Posology’
• Addition of sub heading ‘Special populations’
• Changed sub heading from ‘Children’ to ‘Paediatric population’
• Changed “In patients over the age of 70 years, creatinine clearance should be measured...” to “In patients over the age of 65 years, creatinine clearance should be measured...”

4.4 Special warnings and special precautions for use
• Addition of sub-headers – Myelosuppression and Impaired state of health
• Addition of - In patients aged 65 years or older, creatinine clearance should be measured before start of treatment, see “Renal impairment” and section 4.2. Addition of final paragraph – Excipients - Each Fludara 10 mg film-coated tablet contains 74.75 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.6 Pregnancy and lactation
Addition of the sub-heading “Fertility”

4.8 Undesirable effects
Addition of the “Not Known” column in the table for undesirable effects.

6.4 Special precautions for storage
Storage instructions updated – “Store in the original package to protect from moisture.
This medicinal product does not require any special temperature storage conditions.”

10. DATE OF REVISION OF THE TEXT
Updated on 15/11/2010 and displayed until 01/04/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 14/10/2010 and displayed until 15/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • SPC Submitted in error
Date of revision of text on the SPC:   11-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes made to the following sections:

 

Section 2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of - Excipients:  Lactose monohydrate

 

Section 4.2        Posology and method of administration

Addition of – Paragraph - Fludara oral can be taken either on an empty stomach or together with food. The tablets have to be swallowed whole with water, they should not be chewed or broken.

 

Section 4.4  - Special warnings and precautions for use

Addition of last paragraph - Excipients

 

Each Fludara 10 mg film-coated tablet contains 74.75mg lactose monohydrate.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Section 6.4        Special precautions for storage

Addition of - This medicinal product does not require any special temperature storage conditions

 

Section 7.         MARKETING AUTHORISATION HOLDER

Addition of the marketing authorisation holder

 

Section 8.         MARKETING AUTHORISATION NUMBER(S)

Addition of authorisation number

 

Section 9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Addition of dates for first authorisation and last renewal

 

Section 10 - DATE OF REVISION OF THE TEXT
Updated on 11/12/2009 and displayed until 14/10/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to Sections 7, 8, 9 and 10

In section 7 (Marketing Authorisation Holder), change in ownership
In section 8 (Marketing Authorisation Number), change in number
In section 9 (Date of first Authorisation/Renewal of Authoristion), change of date
In section 10 (Date of revision of text), change of date
Updated on 09/03/2009 and displayed until 11/12/2009
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 4.3 ( Contraindications) - contraindication for pregancy has been removed.

In Sections 4.4 ( Special warnings and precautions) and ( Pregnancy and lactation) - new warnings and available information have been added.

In Section 5.3 (pre-clinical safety data) - The side effect myelodysplastic syndrome and acute myeloid leukaemia has moved from frequency rare, to common. Additionally the footnote that stated 'Monotherapy with Fludara has not been associated with an increased risk for the development of myelodysplastic syndrome / AML' has been deleted.  Also,  a small amount of additional information has been added to the embryotoxicity preclinical safety data.

Section 10 (Revision date) - this is now 26 February 2009
Updated on 16/05/2008 and displayed until 09/03/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May

Section 7: MAH now Bayer plc
Section 8: Licence numbers are now PL 00010/ 0527 & 0528
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 22/02/2008 and displayed until 16/05/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2, 4.3 & 6.6 - editorial changes.
Section 4.2 - rearrangement of text and additional cross references, additional subheading for hepatic impairment, statement that Fludara is not recommended for use in children has been added.
Section 4.4 - new layout, subsections inc myelosuppression, auto immune disorder, neuotoxicity. tumour lysis, transfusion asscoiated graft versus host disease, skin cancer, impaired state of health, renal impairment, the elderly and vaccination.
Section 4.5 - new mentiobn of Dipyridamole and other inhibitors
Section 4.6 - additional information and warning
Section 4.7 - revised wording
Section 4.8 - major update and conversion to MedDRA terminology
Section 5.1 - additional information including data from phase III clinical trial.
Section 5.2 - additional information, rearrangement of text
Section 5.3 editorial changes
Section 10 - revision date now February 2008
Updated on 06/09/2007 and displayed until 22/02/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3: Shelf life has been extended from 3 to 5 years
Section 10 : Revision date has been updated to August 2007
Updated on 28/03/2006 and displayed until 06/09/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/03/2006 and displayed until 28/03/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Updated on 20/12/2004 and displayed until 28/03/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/04/2002 and displayed until 20/12/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • 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 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Black Triangle
Updated on 15/08/2001 and displayed until 16/04/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 02/02/2001 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/01/2001 and displayed until 02/02/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  fludarabine phosphate