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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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: 22/11/2011
SPC Arava 10, 20 and 100mg 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 22/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update of SmPC section 4.4 to reflect the outcome of the clinical study (COLEBI-combination therapy of leflunomide with biologicals) as requested by the CHMP to update the SmPC regarding the unclear benefit-risk ratio of leflunomide with biologicals and to update the SmPC with the tuberculosis cases observed during the combination with the biologicals.
Updated on 21/11/2011 and displayed until 22/11/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   10-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 and 5.1 - updated with information about use of a loading dose from post-marketing studies
Updated on 12/05/2011 and displayed until 21/11/2011
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   18-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Special Warnings and precautions for use


Respiratory reactions

 

Interstitial lung disease has been reported during treatment with leflunomide (see section 4.8). The risk of its occurrence is increased in patients with a history of interstitial lung disease. Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy. Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.


Section 4.6: (formerly) Pregnancy and Lactation
change of section title to:-


4.6     Fertility, pPregnancy and lactation


Section 4.8: Undesirable effects, first para changed, as follows:-
 

The most frequently adverse effects reported adverse effects commonly (³1/100 to <1/10) with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin)).
Updated on 13/08/2010 and displayed until 12/05/2011
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   20-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Amendment to typographical errors re product strength detail only in Section 8. Please note that the Data of revision of text has not changed
Updated on 24/05/2010 and displayed until 13/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   29-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of warning about Progressive Multifocal Encephalopathy
Updated on 10/12/2009 and displayed until 24/05/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   02-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of study data in section 4.6 pregnancy and lactation
Updated on 03/09/2009 and displayed until 10/12/2009
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Addition of link to EMEA website
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Reformatting of section 2; 4.2; 4.8; 5.1; 6.5

Removal from Section 4.4 of: -

"Arava should be administered to patients only under careful medical supervision"
Updated on 07/01/2009 and displayed until 03/09/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Correction of spelling/typing errors
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
Section 6.1 - typographical mistake amended
Updated on 21/05/2008 and displayed until 07/01/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
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
Addition of renal failure with unknown frequency to section 4.8
Updated on 23/01/2008 and displayed until 21/05/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.8 Undesirable effects

Addition of renal failure (unknown frequency) as an undesirable effect.
Updated on 21/03/2006 and displayed until 23/01/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/03/2006 and displayed until 21/03/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • SPC Retired pending re-submission
Updated on 04/01/2005 and displayed until 21/03/2006
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 4.8 - Undesirable Effects
Updated on 16/06/2004 and displayed until 04/01/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
Updated on 05/02/2004 and displayed until 16/06/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 24/11/2003 and displayed until 05/02/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 18/09/2003 and displayed until 24/11/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 19/09/2002 and displayed until 18/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 13/09/2002 and displayed until 19/09/2002
Reasons for adding or updating:
  • 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
  • Correction of spelling/typing errors
Updated on 29/04/2002 and displayed until 13/09/2002
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 24/08/2001 and displayed until 29/04/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  leflunomide