Xeplion 25 mg, 50 mg, 75 mg, 100 mg and 150 mg prolonged-release suspension for injection

  • Name:

    Xeplion 25 mg, 50 mg, 75 mg, 100 mg and 150 mg prolonged-release suspension for injection

  • Company:
    info
  • Active Ingredients:

    Paliperidone palmitate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/10/18

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Summary of Product Characteristics last updated on medicines.ie: 22/10/2018

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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 23 October 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 October 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 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 28 June 2018 PIL

Reasons for updating

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

Updated on 27 June 2018 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

Section 4.4. – addition of sodium content statement

Section 4.8 – addition of ADRs: somnambulism (frequency rare) and sleep related eating disorder (frequency not known)

Updated on 27 June 2018 PIL

Reasons for updating

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

Updated on 8 March 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 8 March 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2: addition of dosage conversion table to provide guidance for HCPs when switching patients from paliperidone tablets to paliperidone palmitate long acting injection

Section 10: 01 March 2018

Updated on 9 December 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.2 - 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

Section 2 – added ‘prolonged release’

Section 4.2 – added ‘prolonged release’

-          Under Method of administration, added ‘It must not be administered by any other route.’ Added ‘deltoid or gluteal’.

 

4.4  - replaced ‘Hyperprolactinaemia’ with ‘Use in patients with prolactin-dependent tumours’

4.8 – updated table throughout

5.2 – Updated under ‘Elderly’

10 – Updated Date of Revision

 

Updated on 8 December 2016 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 8 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 June 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2: '/ml' deleted from product strengths

Section 9:
Date of latest renewal:

04 March 201616 December 2015

Updated on 21 December 2015 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 August 2015 PIL

Reasons for updating

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

Updated on 8 May 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 17 September 2013 PIL

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 16 September 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 6 July 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 26 October 2011 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 8 April 2011 PIL

Reasons for updating

  • New PIL for new product