Concerta XL 36 mg prolonged-release tablets
*Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 09 November 2022
File name
PI-Concerta XL-36 mg-Ireland-English-IAIN_111.pdf
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
DE/H/6007/001-004/IA/111 - Update EUPI following PRAC recommendation EoP - 2-November-2022
Updated on 09 November 2022
File name
PIL-Concerta XL-18-36 mg-Ireland-English-IAIN_111.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
DE/H/6007/001-004/IA/111 - Update EUPI following PRAC recommendation EoP - 2-November-2022
Updated on 05 August 2022
File name
PI-Concerta XL-36 mg-Ireland-English-II_107.pdf
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
DE_H_6007_001-004_II_107_ Adult de novo Indication
Updated on 05 August 2022
File name
PIL-Concerta XL-18-36 mg-Ireland-English-II_107.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
DE_H_6007_001-004_II_107_ Adult de novo Indication
Updated on 16 May 2022
File name
PI-Concerta-36 mg-Ireland-English-DE_H_6007_001-004_IA_104_consolidated_II_92.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction to add back 2 missing paragraphs which already had been approved.
Section 4.4:
Use with serotonergic medicinal products
Serotonin syndrome has been reported following coadministration of methylphenidate with serotonergic medicinal products. If concomitant use of methylphenidate with a serotonergic medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is important. These symptoms may include mental‑status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). Methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected.
Section 4.5:
Use with serotonergic medicinal products
There have been reports of serotonin syndrome following coadministration of methylphenidate with serotonergic medicinal products. If concomitant use of methylphenidate with a serotonergic medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is important (see section 4.4). Methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected.
Updated on 12 October 2020
File name
SPC-Concerta-36 mg-Ireland-English-DE_H_6007_001-004_IA_104_EDMS-ERI-138444856_11.0-C25-7Oct2020-cl.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 12 October 2020
File name
PIL-Concerta-18-36 mg-Ireland-English-DE_H_6007_001-004_IA_104_EDMS-ERI-183377703_8.0-7Oct2020-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 22 September 2020
File name
CONCERTA 36 XL_Tablet, Film Coated, Extended Release clean.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 September 2020
File name
IE-Concerta-PIL 18_36mg.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Concerta XL contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’.
Updated on 05 August 2020
File name
IE-Concerta-SPC 27mg-EN-20200529-IB-102-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PI update in line with Excipient guideline
Updated on 12 April 2019
File name
IE-Concerta-PIL-18-36mg-Brexit-clean.pdf
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
File name
IE-Concerta-SmPC-36mg-C22-29mar19-Brexit-clean.pdf
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 06 March 2019
File name
UK-IE-Concerta-PIL-18-36-54mg-II092-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 06 March 2019
File name
IE-Concerta XL-SmPC-36mg-C21-II092-Clean.pdf
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
File name
PIL-Concerta XL-18-36-54mg-C20-11jul18-clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 17 July 2018
File name
Concerta XL-IE-SmPC-36mg-C20-11jul18-clean.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 February 2018
File name
PIL_9209_403.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2018
File name
PIL_9209_403.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2018
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
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
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
Updated on 20 March 2017
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
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
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 |
|||||||
|
Frequency |
||||||||
|
Very common |
Common |
Uncommon |
Rare |
Very rare |
Not known |
|
||
|
Psychiatric disorders* |
Insomnia, Nervousness |
|
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 |
|
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* |
Cardiac murmur* |
|
|
|
|
|
|
* 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
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 September 2015
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
Updated on 20 July 2015
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
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 02 September 2014
Reasons for updating
- Change to information about driving or using machinery
- Change to date of revision
Updated on 28 November 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 August 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 June 2011
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 01 November 2010
Reasons for updating
- Change to side-effects
Updated on 08 February 2010
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
Reasons for updating
- PIL re-instated
Updated on 28 August 2008
Reasons for updating
- Addition of marketing authorisation holder
Updated on 17 October 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 03 September 2007
Reasons for updating
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
Updated on 16 January 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 19 May 2005
Reasons for updating
- Change to storage instructions
- Change to warnings or special precautions for use
Updated on 16 November 2004
Reasons for updating
- New PIL for medicines.ie