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Hospira UK Ltd

Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
Telephone: +44 (0)1926 820 820
Fax: +44 (0) 1926 834446
WWW: http://www.hospira.com
Medical Information Direct Line: +44 (0) 1926 834400
Medical Information e-mail: medinfouk@hospira.com
Customer Care direct line: +44 (0)1926 821 022

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: 24/08/2011
SPC Fluorouracil 25 mg/ml Injection

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 24/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   12-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



 

4.8.      Undesirable effects

 TEXT ADDED

Diarrhoea, nausea and vomiting are observed quite commonly during therapy and may be treated symptomatically.  An anti-emetic may be given for nausea and vomiting.

 

Alopecia may be seen in a substantial number of cases, particularly females, but is reversible.  Other side effects include dermatitis, pigmentation, changes in nails, ataxia and fever.

 

There have been reports of chest pain, tachycardia, breathlessness and E.C.G. changes after administration of Fluorouracil.  Special attention is advisable in treating patients with a history of heart disease or those who develop chest pain during treatment.

 

Leucopenia is common and the precautions described above should be followed.

 

Systemic fluorouracil treatment has been associated with various types of ocular toxicity.  Peripheral neuropathy may occur.

 

A transient reversible cerebellar syndrome has been reported following fluorouracil treatment.  Rarely, a reversible confusional state may occur. Cases of leucoencephalopathy have also been reported.

 

Additionally several other reports have been noted including:

 

Incidences of excessive lacrimation dacryostenosis, visual changes and photophobia.

 

Palmar-Plantar Erythrodysesthesia Syndrome has been reported as an unusual complication of high dose bolus or protracted continuous therapy for 5-fluorouracil.

 

Thrombophlebitis / Vein Tracking.

DATE OF REVISION OF THE TEXT
DATE CHANGE

             12 August 2011

Updated on 13/05/2009 and displayed until 24/08/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



7.         MARKETING AUTHORISATION HOLDER

 Change to:

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW

United Kingdom.

10        DATE OF REVISION OF THE TEXT

            02 January 2008

Updated on 27/01/2005 and displayed until 13/05/2009
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 26/04/2004 and displayed until 27/01/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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
Updated on 09/08/2001 and displayed until 26/04/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 06/09/1999 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   fluorouracil