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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: 13/09/2011
SPC Concerta XL 27 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 13/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Sep-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

Aggressive or hostile behaviour

The emergence or worsening of aggression or hostility can be caused by treatment with stimulants. Patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit. Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.

Section 4.9 Overdose

When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from this formulations with extended durations of action
Updated on 02/09/2011 and displayed until 13/09/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
error, missing word adolscents in first paragraph
Updated on 22/06/2011 and displayed until 02/09/2011
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and method of administration
under 'Adults' change to advice to allow continuation into adulthood.

Now states; 'In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, start of treatment with CONCERTA XL in adults is not appropriate (see sections 4.4 and 5.1).'

Section 4.4 Special warnings and precautions
Use in adults . text update to :'  Safety and efficacy have not been established for the initiation of treatment in adults or the routine continuation of treatment beyond 18 years of age. If treatment withdrawal has not been successful when an adolescent has reached 18 years of age continued treatment into adulthood may be necessary. The need for further treatment of these adults should be reviewed regularly and undertaken annually.

Cardiovascular status:  'The possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data especially when treatment during childhood/adolescence is continued into adulthood.

Section 4.8 Undesirable effects

  Addition of adverse events seen in adult clinical traisl.

Section 5.1   Pharmacodynamics: addition of adult clinical trial efficacy data (18 to 65 years)
Updated on 10/11/2010 and displayed until 22/06/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   21-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 02/11/2010 and displayed until 10/11/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   21-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2

Addition of  word 'hydrochloride' next to methylphenidate

Section 4.8

Minor changes to tthe frequncy of the side effects.
Updated on 27/11/2009 and displayed until 02/11/2010
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 - 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 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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:   04-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.1 – Therapeutic Indications

Treatment must be under the supervision of a specialist in childhood behavioural disorder, and emphasis on the need for  remedial measures before introducing pharmacotherapy.

Change to section 4.2 – Posology and |Method of Administration

Requirement for pre-treatent screening and ongoing monitoring

Change to section 4.3 – Contra-indications

Addition of Phaecochromocytoma

Change to section 4.4 – Special Warnings and Precautions for Use

More detailed information on long term effects, ongoing monitoring requirements, and withdrawing medication for trial period

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

Additional caution with domapminergic drugs, clonidine, halogenated anaesthetics , antihypertensive ddrugs

Change to section 4.6 – Pregnancy and Lactation

Pregnancy:Addition of reports of neonatal cardioresipiratory toxicity, specifically foetal tachycardia and respiratory distress

Lactation: methylphenidate has been found in breast milk, one case report of  weight decrease

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Visual disturbances including blurred vision may affect ability to drive or operate machinery

Change to section 4.8 – Undesirable effects

Table has been re-formatted with new system organ classes, in crease in number and type of psychiatric side effects including suicide. Also reports of cerbrovascular accident , neuroleptics malignant syndrome, choreoatheroid movements, hyperhidrosis, muscle cramps gynaecomastia

Change to section 4.9 - Overdose

Section re-written

Change to section 5.3 - Preclinical Safety Data

No new information section re-written

Change to section 10 – Date of revision of the text

Changed to  4th November 2009
Updated on 12/09/2008 and displayed until 27/11/2009
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 2 – quantitative and qualitative composition

Addition of  information that lactose is an excipient

Change to section 4.1 – Therapeutic Indications

‘Drug’ now referred to as ‘medicinal product’ throughout the SPC

Change to section 4.2 – Posology and |Method of Administration

Safety statement referring to children under 6 moved to beginning of section 4.2

Change to section 4.3 – Contra-indications

Minor text changes

Change to section 4.4 – Special Warnings and Precautions for Use

Removal of reference to patients with renal or hepatic inpairtment’

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

Minor text changes

Change to section 4.6 – Pregnancy and Lactation

Minor text changes

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Minor text changes

Change to section 4.8 – Undesirable effects

Change in order of undesirable effects according to frequency of reporting

Change to section 6.1 – List of Excipients

Minor text changes

Change to section 6.4 – Special Precautions for Storage

Addition of  ‘in order to protect from moisture’

Change to section 6.5 – Nature and Contents of Container

Addition of ‘silica gel’

Change to section 10 – Date of revision of the text

Change to 4th September 2008
Updated on 04/08/2008 and displayed until 12/09/2008
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 18/07/2007 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 joint SPC covering all presentations
Date of revision of text on the SPC:   07/2007
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 12/03/2007 and displayed until 18/07/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  methylphenidate hydrochloride