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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC CONCERTA XL 18 mg prolonged-release tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Feb-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Adminatrative changes - No change to SPC content.
Updated on 20/03/2017 and displayed until 19/04/2017
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:   16-Mar-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Inclusion of the following wording on Priapism in Section 4.4:

Priapism

Prolonged and painful erections have been reported in association with methylphenidate products, mainly in association with a change in the methylphenidate treatment regimen. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Addition of Priapism, Erection increased and Prolonged erection as adverse reaction with 'not known' frequency in Section 4.8.

Updated on 18/05/2016 and displayed until 20/03/2017
Reasons for adding or updating:
  • 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:   12-May-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8

Addition of

 

Hepatobiliary disorders –very rare- acute hepatic failure

 

Other ADR changes =changed system organ class


System Organ Class

Adverse Drug Reaction

Frequency

Very common

Common

Uncommon

Rare

Very rare

Not known

 

Psychiatric disorders*

Insomnia, Nervousness

Anorexia, Affect lability, Aggression*, Agitation*, Anxiety*, Depression*#, Irritability, Abnormal behaviour, Mood swings, Tics*, Initial insomnia#, Depressed mood#, Depression#, Libido decreased#, Tension#, Bruxism#, Panic attack#

Psychotic disorders*,  Auditory, visual and tactile hallucination*, Anger, Suicidal ideation*, Mood altered, Restlessness, Tearfulness, Worsening of pre-existing tics of Tourette’s syndrome*, Logorrhoea, Hypervigilance, Sleep disorder

Mania*, Disorientation, Libido disorder, Confusional state

Suicidal attempt (including completed suicide)*, Transient depressed mood*, Abnormal thinking, Apathy, Repetitive behaviours, Over-focussing

Delusions*, Thought disturbances*, dependence. Cases of abuse and dependence have been described, more often with immediate release formulations

 

Hepatobiliary disorders

 

Alanine aminotransferase increased#

Hepatic enzyme elevations increased

 

Abnormal liver function, including acute hepatic failure and hepatic coma, Blood alkaline phosphatase increased, Blood bilirubin increased

 

 

Investigations

 

Changes in blood pressure and heart rate (usually an increase)*, Weight decreased*, Alanine aminotransferase increased#

Cardiac murmur*, Hepatic enzyme increased

 

Blood alkaline phosphatase increased, Blood bilirubin increased, Platelet count decreased, White blood cell count abnormal

 

 

*      See section 4.4

#    Frequency derived from adult clinical trials and not on data from trials in children and adolescents; may also be relevant for children and adolescents.

    Frequency derived from clinical trials in children and adolescent and reported at a higher frequency in clinical trials in adult patients.

 

Updated on 20/07/2015 and displayed until 18/05/2016
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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jul-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Update to section 4.1, 4.2, 4.3 (admin)

Update to section 4.8 _ ADR reporting statement

Update to section 4.9 (overdose)

Treatment

 

There is no specific antidote to methylphenidate overdosage.

 

Treatment consists of appropriate supportive measures.

 

The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. . If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine be given before performing gastric lavage The efficacy of activated charcoal has not been established.

 

 

Updated on 04/09/2014 and displayed until 20/07/2015
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Aug-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.7:

When early discharge is envisaged, patients should be advised not to drive or operate machinery for the 24 hours following administration.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. When prescribing this medicine, patients should be told:

•              The medicine is likely to affect your ability to drive

•              Do not drive until you know how the medicine affects you

•              It may be an offence to drive while under the influence of this medicine

 

Updated on 04/03/2013 and displayed until 04/09/2014
Reasons for adding or updating:
  • 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:   22-Feb-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.5 Interaction:

 

Use with centrally acting alpha‑2 agonists (e.g. clonidine)

 

Serious adverse events, including sudden death, have been reported in concomitant use with clonidine.

The  long-term safety of using methylphenidate in combination with clonidine or other centrally acting alpha‑2 agonists has not been systematically evaluated.

Updated on 27/11/2012 and displayed until 04/03/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Nov-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8

Addition of  “ logorrhoea” under Psychiatric Disorders~ uncommon and “pollakiura” under renal and urinary disorders ~uncommon

Updated on 14/09/2011 and displayed until 27/11/2012
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:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions

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 27/06/2011 and displayed until 14/09/2011
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
Date of revision of text on the SPC:   23-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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 trials.

Section 5.1   Pharmacodynamics:
addition of adult clinical trial efficacy data (18 to 65 years)
Updated on 10/11/2010 and displayed until 27/06/2011
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:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

 section 4.2 addition of 'hydrochloride' after methylphenidate

Section 4.8 _ no addtional adverse effects chnage in frequency of several ADRS
Updated on 11/03/2010 and displayed until 10/11/2010
Reasons for adding or updating:
  • 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
  • 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
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



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.

4.2

Posology and method of administration

Addition of Phaecochromocytoma

4.3

Contraindications

Addition of Phaecochromocytoma

4.4

Special Warnings and Precautions for Use

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

4.5

Interaction with other medicinal products and other forms of interaction

Additional caution with dopaminergic drugs, clonidine, halogenated anaesthetics , antihypertensive drugs

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

4.7

Effects of ability to drive and use machines

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

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 cerebrovascular accident , neuroleptics malignant syndrome, choreoatheroid movements, hyperhidrosis, muscle cramps, gynaecomastia

4.9

Overdose

No new information section re-written

 

5.3

Preclinical Safety Data

No new information section re-written

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to Ferbruary 2010

 

Updated on 12/02/2009 and displayed until 11/03/2010
Reasons for adding or updating:
  • SPC re-instated
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

SmPC retired in error, now re-instated
 
Updated on 12/02/2009 and displayed until 12/02/2009
Reasons for adding or updating:
  • Introduction of new strength
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

New SPC for new product

New Strength of Concerta XL

8.

MARKETING AUTHORISATION NUMBER(S)

PA 748/49/4

 

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01 August 08

 

10.

DATE OF REVISION OF THE TEXT

August 08

 

Updated on 01/09/2008 and displayed until 12/02/2009
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:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

7.

MARKETING AUTHORISATION HOLDER

Update address to 50-100 Holmers Farm Way

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to August 2008

 

Updated on 17/10/2007 and displayed until 01/09/2008
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
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

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 September 2007

Change to separate SPCs covering individual presentations                                                                                                                                                                                                     

 

Updated on 27/07/2007 and displayed until 17/10/2007
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 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of 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:   prescription only

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 intolreance’ 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 08/03/2007 and displayed until 27/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/01/2007 and displayed until 08/03/2007
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
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Special Warnings and Precautions for Use

Updated: warning in patients with cardiac structural abnormalities

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

Updated INN names for Phenobarbital and amfetamine

Updated on 17/05/2005 and displayed until 11/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
Updated on 18/03/2004 and displayed until 17/05/2005
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
Updated on 05/06/2003 and displayed until 18/03/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Methylphenidate Hydrochloride