The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen-cilag.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550
Need to contact this company?
Summary of Product Characteristics last updated on the eMC: 04/08/2008
SPC Concerta XL 18 mg - 36 mg Prolonged-Release 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 04/08/2008 and displayed until Current
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:   29-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

Updated to High Wycombe address

Change to section 10 – Date of revision of the text

Updated to 29th July 2008
Updated on 21/06/2007 and displayed until 04/08/2008
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 10 date of revision of the text
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of mania/aggression sub-headings & text

 

Change to section 4.8 – Undesirable effects

Major revision to update to 2005 SPC guidance

 

Change to section 10 – Date of revision of the text

Changed to 20th June 2007

 

Change to separate SPCs covering individual presentations                                                                                                                                                                                                     

Updated on 07/06/2007 and displayed until 21/06/2007
Reasons for adding or updating:
  • 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 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Change in position of ‘Children (under 6 years of age) section to beginning of section 4.2.

Change to section 4.4 – Special Warnings and Precautions for Use

Change in position of ‘Use in patients with renal hepatic impairment’ from this section into section 4.2

 

Under section heading ‘Galactose intolerance’ additional statement adding ‘This medicinal product contains lactose’

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Addition of cross-references to sections 4.3 and 4.4

Change to section 4.6 – Pregnancy and Lactation

Addition of section headings: ‘Women of childbearing potential/Contraception ; Pregnancy ; Lactation

Change to section 6.1 – List of Excipients

Excipients capitalised and listed sequentially

Change to section 6.6 –  Instructions for use, handling and disposal

Section heading updated

Change to section 9 – Date of Renewal of Authorisation

Updated to add ‘6 June 2007’ ; sub-section headings added

Change to section 10 – Date of revision of the text

Updated to add ‘6 June 2007’

Change to joint SPC covering all presentations                                                                

 
Updated on 01/12/2006 and displayed until 07/06/2007
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.4

Special Warnings and Precautions for Use

Addition: warning in children with cardiac structural abnormalities

4.5

Interaction with other medicinal products and other forms of interaction

INN name  change Phenobarbital and amfetamine

 

10.

DATE OF REVISION OF THE TEXT

 

 

Updated
Updated on 13/02/2006 and displayed until 01/12/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 18/03/2004 and displayed until 13/02/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 07/01/2003 and displayed until 18/03/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/12/2002 and displayed until 07/01/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.6 - 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 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/02/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  methylphenidate


Return to the top of the page

© 2009 Datapharm Communications Ltd

Go to www.medicines.org.uk