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Arava 10mg Tablets

Last Updated on eMC 09-Aug-2017 View document  | SANOFI Contact details

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 09-Aug-2017 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: 14-Jul-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

 

  In Section 4.4 (special warnings and precautions for use) the following has been under Lactose:-

Interference with determination of ionised calcium levels

The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser). Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide. In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.

 

Updated on 17-Feb-2016 and displayed until 09-Aug-2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Respiratory reactions

 

Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).

Updated on 19-Nov-2015 and displayed until 17-Feb-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage

Date of revision of text on the SPC: 22-Oct-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.2- Formatted text

4.3- Formatted text

4.4- Formatted text and Colitis reported in patients treated with leflunomide

4.5- Formatted text

4.6- Adverse effects on male reproductive organs were observed (animals)

4.8- Colitis added

5.2- Formatted text

6.4- Wording update.

Updated on 10-Oct-2014 and displayed until 19-Nov-2015

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 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 25-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IIC Bulk - CCDS v18 and v19 (WS 560 v62)

Updated on 04-Jun-2014 and displayed until 10-Oct-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 22-May-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IB - DRESS Syndrome and PRAC recommendations. The information of local representatives for Finland, Malta, Sweden and UK has also been updated (WS 0526).

Updated on 21-Feb-2014 and displayed until 04-Jun-2014

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 05-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IA-IN bulk - Addition of Croatia QRD v9. EMEA/H/C/235/IAin/354/G

Updated on 08-Jan-2013 and displayed until 21-Feb-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 18-Dec-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Variation 56 - skin disorders

Updated on 20-Jun-2012 and displayed until 08-Jan-2013

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 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC: 19-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update of the SPC and PIL section 4.4 and 4.8 regarding peripheral neuropathy further to the LRC - 13 July 2011 - CCDS V16.

Updated on 10-Apr-2012 and displayed until 20-Jun-2012

Reasons for adding or updating:

  • New individual SPC (was previously included in combined SPC)

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To update section 4.4 and 4.8 of the SPC (and PIL) regarding peripheral neuropathy further to LRC - 13 July 2011-CCDS V16.

Company contact details

SANOFI

Company image
Address

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Fax

+44 (0)1483 535 432

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

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?

Active ingredients

leflunomide

Legal categories

POM - Prescription Only Medicine

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