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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: 20/01/2009
SPC Methotrexate 10 mg Tablets

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 20/01/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • 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:   01-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4     Special warnings and special precautions for use
Warnings 
Section added:
Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.  Symptoms typically include dyspnoea, cough (especially a dry non-productive cough) and fever for which patients should be monitored at each follow-up visit.  Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Methotrexate should be withdrawn from patients with pulmonary symptoms and a thorough investigation should be made to exclude infection.  If methotrexate induced lung disease is suspected treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.

4.8     Undesirable effects
Pulmonary System: WORD DELETED Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported (see Section 4.4 Special warnings and special precautions for use). BOLD TEXT ADDED  Acute pulmonary oedema has also been reported after oral and intrathecal use.  Pulmonary fibrosis is rare.  A syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses.

7.       MARKETING AUTHORISATION HOLDER
 CHANGE TO:
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire, CV31 3RW

10.     DATE OF (PARTIAL) REVISION OF THE TEXT
CHANGE TO:
January 2008
Updated on 11/04/2003 and displayed until 20/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  methotrexate