Concerta XL 27mg

  • Name:

    Concerta XL 27mg

  • 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

Company Products

Medicine NameActive Ingredients
Medicine Name Caelyx pegylated liposomal 2mg/ml concentrate for solution for infusion Active Ingredients Doxorubicin hydrochloride
Medicine Name CONCERTA XL 18 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 27mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 36 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Dacogen 50 mg powder for concentrate for solution for infusion. Active Ingredients Decitabine
Medicine Name Daktacort 2% 1% Cream Active Ingredients Hydrocortisone, Miconazole nitrate
Medicine Name DARZALEX 20 mg/mL concentrate for solution for infusion. Active Ingredients Daratumumab
Medicine Name Durogesic DTrans 100 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 12 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 25 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 50 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 75 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans Transdermal Patch Active Ingredients Fentanyl
Medicine Name Edurant 25mg film-coated tablets Active Ingredients Rilpivirine Hydrochloride
Medicine Name Erleada 60 mg film coated tablets Active Ingredients Apalutamide
Medicine Name Evorel 50 micrograms per 24 hours Transdermal Patch Active Ingredients Estradiol Hemihydrate
Medicine Name Evorel Conti Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Evra transdermal patch Active Ingredients Ethinylestradiol, Norelgestromin
Medicine Name Gyno-Daktarin 20 mg/g vaginal cream Active Ingredients Miconazole nitrate
Medicine Name Gyno-Pevaryl Once 150mg vaginal pessary Active Ingredients Econazole Nitrate
Medicine Name Haldol Decanoate Active Ingredients Haloperidol decanoate
Medicine Name IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg film-coated tablets Active Ingredients Ibrutinib
Medicine Name Intelence 200 mg tablets Active Ingredients Etravirine
Medicine Name Invega 3 mg, 6mg, 9mg, 12mg prolonged-release tablets Active Ingredients Paliperidone
Medicine Name Lyrinel XL 5mg & 10mg prolonged release tablets Active Ingredients Oxybutynin Hydrochloride
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)

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 17 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 17 July 2015 PIL

Reasons for updating

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

Updated on 17 July 2015 SmPC

Reasons for 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

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 2 September 2014 SmPC

Reasons for updating

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

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 2 September 2014 PIL

Reasons for updating

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

Updated on 4 March 2013 SmPC

Reasons for 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

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 28 November 2012 PIL

Reasons for updating

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

Updated on 27 November 2012 SmPC

Reasons for 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

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 September 2011 SmPC

Reasons for 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

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 warningd 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 2 September 2011 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

spellin errors

Updated on 16 August 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 June 2011 SmPC

Reasons for 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

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 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 5 November 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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

word 'hydrochloride' added next to methylphenidate.


Section 4.8


Minotr chnages to the frequency of side effects

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 March 2010 SmPC

Reasons for 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

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 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 16 February 2009 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 13 February 2009 PIL

Reasons for updating

  • New PIL for new product