Concerta XL 36 mg prolonged-release tablets

  • Name:

    Concerta XL 36 mg prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Methylphenidate Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/04/19

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Summary of Product Characteristics last updated on medicines.ie: 12/4/2019

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Janssen Sciences Ireland

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1 - 0 of 55 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 12 April 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 March 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 6 March 2019 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

CCDS Dec 2016 (092) safety change

Updated on 17 July 2018 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 17 July 2018 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.1     List of excipients

 

Butylhydroxytoluene (E321)

Cellulose acetate

Hypromellose (E464)

Phosphoric acid concentrated

Poloxamer 188

Polyethylene oxides 200K and 7000K

Povidone K29-32

Sodium chloride

Stearic acid

Succinic acid

Iron oxide black (E172)

Iron oxide yellow (E172)

 

Film Coat

 

Hypromellose (E464)

Lactose monohydrate

Titanium dioxide (E171)

Triacetin

 

Clear Coat

 

Carnauba wax

Hypromellose (E464)

Macrogol 400

 

Printing Ink

 

Iron oxide black (E172)

Hypromellose (E464)

Isopropyl alcohol

Propylene glycol

Purified water

Updated on 19 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018 SmPC

Reasons for 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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. Aggression has been reported in patients treated with methylphenidate (see section 4.8). 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.

Anxiety, agitation or tension

Anxiety, agitation and tension have been reported in patients treated with methylphenidate (see section 4.8). Methylphenidate is also associated with the worsening of pre-existing anxiety, agitation or tension, and anxiety led to discontinuation of methylphenidate in some patients. Clinical evaluation for anxiety, agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening of these symptoms during treatment, at every adjustment of dose and then at least every 6 months or every visit.

4.6     Fertility, pregnancy and lactation

Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate. Methylphenidate is excreted in human milk. Based on reports of breast milk sampling from five mothers, methylphenidate concentrations in human milk resulted in infant doses of 0.16% to 0.7% of the maternal weight‑adjusted dosage, and a milk to maternal plasma ratio ranging between 1.1 and 2.7.

5.2     Pharmacokinetic properties

Replacement of (0-inf) with inf throughout

Updated on 19 February 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 19 April 2017 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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 March 2017 SmPC

Reasons for 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

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 17 March 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 May 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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 17 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 22 September 2015 SmPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

correction of error

Updated on 20 July 2015 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 17 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 2 September 2014 PIL

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 28 November 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 August 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 June 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 1 November 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 February 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 12 February 2009 PIL

Reasons for updating

  • PIL re-instated

Updated on 28 August 2008 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 17 October 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 3 September 2007 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 16 January 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 19 May 2005 PIL

Reasons for updating

  • Change to storage instructions
  • Change to warnings or special precautions for use

Updated on 16 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie