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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: 02/03/2012
SPC RISPERDAL CONSTA 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection

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 02/03/2012 and displayed until Current
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:   29-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Updated with PhVWP wording for neonate withdrawal syndrome.
Updated on 11/11/2011 and displayed until 02/03/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   05-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Text amended for clarity and to be inline with QRD
Updated on 11/04/2011 and displayed until 11/11/2011
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 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 Addition of  warning re hyperglycaemia, diabetes mellitus and exacerbation of existing diabetes mellitus to section 4.4.
 Addition of  hyperglycaemia, diabetes mellitus and hypoglycaemia as ADRs to section 4.8

Update and clarification of instructions for use (section 6.6).
Updated on 21/07/2010 and displayed until 11/04/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 5.3 - Addition of toxicity data for juvenile rats and dogs.
Change to section 10 - 16.07.10
Updated on 29/06/2010 and displayed until 21/07/2010
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 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
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 VTE. Update of class labelling text re increased mortality in elderly patients with dementia and CVAE.

Change to section 4.8 - Undesirable Effects

Addition of class labelling text for VTE. Addition of urinary retention as an uncommon ADR.

Change to section 6. 5 - Nature and Contents of Container

Addition of mm as measurement unit to description of needle gauge.

Change to section 6. 6 - Instructions for use, handling and disposal

Addition of mm as measurement unit to description of needle gauge.

Change to section 10 - Date of revision of the text

04.06.10
Updated on 25/01/2010 and displayed until 29/06/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.2 – Posology and Method of Administration

Addition of  information regarding deltoid injection site.

Change to section 6.5 – Nature and Contents of Container*

 Addition of deltoid needle description.

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

Addition of deltoid needle information plus clarification of instructions for use.

Change to section 10 – Date of revision of the text

07.10.09
Updated on 08/05/2009 and displayed until 25/01/2010
Reasons for adding or updating:
  • 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-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 – Undesirable effects

Addition of information re rare , serious injection site reactions  reported  in post-marketing surveillance.

Change to section 10 – Date of revision of the text

01.04.09
Updated on 17/12/2008 and displayed until 08/05/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   08-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change due to harmonisation of SPC

 

Change to section 4.8 – Undesirable effects

ADR’s listed by System, Organ, Class. Addition of ADR’s reported with oral Risperdal but not with Consta.

Change to section 4.1 – Therapeutic Indications

Clarification of indication- “maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics

 

Change to section 10 – Date of revision of the text

08.12.08
Updated on 10/09/2008 and displayed until 17/12/2008
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   27-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 

Change to Marketing Authorisation Holder Address
Updated on 27/11/2007 and displayed until 10/09/2008
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
Date of revision of text on the SPC:   11/2007
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 warning  re rare possibility of retinal artery occlusion

Change to section 4.8 – Undesirable effects

Addition of warning  re rare possibility of retinal artery occlusion

Change to section 10 – Date of revision of the text

20.11.07
Updated on 01/11/2007 and displayed until 27/11/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Change to section 6.5 – Nature and Contents of Container

Update of dosage form component description

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

Simplified instructions for use and handling
Updated on 30/07/2007 and displayed until 01/11/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Addition of warning for angioedema and benign pituitary adenoma
Updated on 18/07/2007 and displayed until 30/07/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
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

Topiramate extra paragraph

Change to section 5.2 - Pharmacokinetic properties

Topiramate extra paragraph

Change to section 10 – Date of revision of the text

16th july 2007
Updated on 29/09/2006 and displayed until 18/07/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

4.6

Pregnancy and Lactation

Updated with CCDS Oct-2005 wording: “Reversible extrapyramidal symptoms in the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy.”
Updated on 27/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • 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:   09/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

4.8

Undesirable effects

Updated with Oculogyric crisis wording

10.

DATE OF REVISION OF THE TEXT

 

06-09-2006

 
Updated on 29/03/2006 and displayed until 27/09/2006
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 10/03/2006 and displayed until 29/03/2006
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
  • Pending awaiting re-submission
Updated on 01/03/2006 and displayed until 10/03/2006
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 31/03/2005 and displayed until 01/03/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 31/03/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 25/05/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 18/03/2004 and displayed until 25/05/2004
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/09/2003 and displayed until 18/03/2004
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 01/09/2003 and displayed until 03/09/2003
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 01/09/2003 and displayed until 01/09/2003
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 06/02/2003 and displayed until 01/09/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 19/12/2002 and displayed until 06/02/2003
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 13/08/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  risperidone