Invega 3 mg, 6mg, 9mg, 12mg prolonged-release tablets *

  • Company:

    Janssen Sciences Ireland
  • Status:

    No Recent Update
  • Legal 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

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 25 May 2021

File name

NI& IRE SPC -Invega-clean-approved -SPC_1621957935.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

4.8       Undesirable effects

Undesirable effects noted with risperidone formulations

Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperidone products and can be expected to occur with INVEGA.

Psychiatric disorders: sleep-related eating disorder

Nervous system disorders: cerebrovascular disorder

Eye disorders: floppy iris syndrome (intraoperative)

Respiratory, thoracic and mediastinal disorders: rales

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis

Updated on 25 May 2021

File name

NI& IRE PIL-Invega--clean-approved -April 2021_1621957330.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 14 October 2020

File name

Invega PIL C17-13Sep18-clean_1602665621.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Change to section 2 - interactions with other medicines, food or drink Change to section 4 - possible side effects. Change local representtaive in Ireland.

Updated on 23 October 2018

File name

Invega-SmPC-C16-13Sep18-clean_1540202639.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 22 October 2018

File name

Invega-SmPC-C16-13Sep18-clean_1540203071.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 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

Addition of information regarding concomitant use with psychostimulants (Section 4.4 and 4.5). Addition of a new side-effect catatonia categorised as ‘rare’ (Section 4.8).  

Updated on 22 October 2018

File name

UK-INVEGA PI C16-13sep18-clean_1540202742.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 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)

Free text change information supplied by the pharmaceutical company

Addition of information regarding concomitant use with psychostimulants (Section 4.4 and 4.5). Addition of a new side-effect catatonia categorised as ‘rare’ (Section 4.8).  

Updated on 21 August 2018

File name

Invega-SmPC-C15-15Aug18-clean_1534866658.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 27 June 2018

File name

Invega-C14-SmPC 20180531-Clean.docx

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

Section 4.4. – addition of sodium content statement

Section 4.8 – addition of ADRs: somnambulism and sleep related eating disorder

Updated on 27 June 2018

File name

Invega PIL C16-31May18-Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 September 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)
  • 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

4.2       Posology and method of administration

Renal impairment

For patients with moderate to severe renal impairment (creatinine clearance ³ 10 to < 50 ml/min), the recommended initial dose of INVEGA is 1.5 mg 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance below 10 ml/min, use is not recommended in such patients.

4.9       Overdose

 

In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in association with overdose. In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.

 

Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. Gastric lavage (after intubation if the patient is unconscious) and a Administration of activated charcoal together with a laxative should be considered. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.

 

Updated on 05 September 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

Renal impairment

For patients with moderate to severe renal impairment (creatinine clearance ³ 10 to < 50 ml/min), the recommended initial dose of INVEGA is 1.5 mg 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance below 10 ml/min, use is not recommended in such patients.

4.9       Overdose

 

In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in association with overdose. In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.

 

Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. Gastric lavage (after intubation if the patient is unconscious) and a Administration of activated charcoal together with a laxative should be considered. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.

 

Updated on 01 September 2017

File name

PIL_12347_587.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 June 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

In section 4.1, the indication for treatment of schizoaffective disorder in adults has been modified.$0$0$0$0Long term trial data has been added to section 5.1.$0

Updated on 08 June 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

In section 4.1, the indication for treatment of schizoaffective disorder in adults has been modified.$0$0$0$0Long term trial data has been added to section 5.1.$0

Updated on 14 May 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

Addition ofpaediatric indication- treatment of schizophrenia in adolescents 15 years andolder.

Updated on 14 May 2015

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition ofpaediatric indication- treatment of schizophrenia in adolescents 15 years andolder.