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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.co.uk
WWW: http://www.janssen-medinfo.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

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: 17/05/2012
SPC INVEGA 1.5 mg, 3 mg, 6 mg, 9 mg, 12 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 17/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   15-May-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Renewal updates
Updated on 27/10/2011 and displayed until 17/05/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   12-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.6 and 4.8 updated with neonatal withdrawal syndrome.
Updated on 14/01/2011 and displayed until 27/10/2011
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   13-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Addition of schizoaffective disorder indication to section 4.1, with related changes to sections 4.2, 4.4, 4.5, 4.8 and 5.1.
Updated on 23/07/2010 and displayed until 14/01/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - Addition of clozapine to list of drugs which lower seizure threshold.
Change to section 4.8 - Addition of new common ADR's e.g. urinary tract infection, blurred vision, stomach discomfort, constipation.
Change to section 10 - 01 July 2010.
Updated on 22/12/2009 and displayed until 23/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Additional side effects added, including agitation (common).
Change to section 4.9 - Statement regarding Torsade de Pointes added.
Change to section 10 - Changed to November 2009
Updated on 23/11/2009 and displayed until 22/12/2009
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
Date of revision of text on the SPC:   05-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Addition of class labelling text for venous thromboembolism

Change to section 4.8 – Undesirable effects

Addition of class labelling text for venous thromboembolism

Change to section 10 – Date of revision of the text

Changed to 11/2009
Updated on 14/08/2009 and displayed until 23/11/2009
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
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Update of warning regarding priapism

Change to section 4.8 – Undesirable effects

 Addition of priapism to frequency not known category

Change to section 10 – Date of revision of the text

07.07.09
Updated on 28/01/2009 and displayed until 14/08/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
  • Introduction of new strength
Date of revision of text on the SPC:   12-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 3 – pharmaceutical form

Editorial change to tablet description

Change to section 4.2 – Posology and |Method of Administration

 Addition of info re incremental dose increases., and dose for patients with renal impairment.

Change to section 10 – Date of revision of the text

12.01.09

Correction of spelling/typing errors                                                                                                                                                                                                                           

Correction of minor typo’s throughout document

Addition of new strength                                                                                                                                                                                                                                       

Addition of 1.5 mg strength
Updated on 08/05/2008 and displayed until 28/01/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   30-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


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

Addition of information regarding interaction with carbamazepine
Updated on 28/06/2007 and displayed until 08/05/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  paliperidone