Xeplion 25 mg, 50 mg, 75 mg, 100 mg and 150 mg prolonged-release suspension for injection
*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 29 May 2023
File name
20230525 Type II EN Xeplion-pronoged-release suspension-PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Correction of spelling/typing errors
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Approval of Variation type IIEMEA/H/C/XXXX/WS/2405 AE updates + editorial changes + IFU updates
Updated on 29 May 2023
File name
20230525 Type II WS2405 EN Xeplion-prolonged-release suspension-SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- 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
Variation type II Approval EMEA/H/C/XXXX/WS/2405 AE updates + editorial changes
Updated on 25 May 2021
File name
NI & IE SPC-Xeplion-clean-approved-April 2021.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)
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 & IE PIL-Xeplion-clean-approved-April 2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 October 2018
File name
Xeplion-C11-PIL-13Sep18-clean.pdf
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
File name
Xeplion C16 Combined SmPC 13Sep18 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 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
File name
Xeplion-C10-PIL-31May2018-CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 June 2018
File name
Xeplion C15 Combined 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 (frequency rare) and sleep related eating disorder (frequency not known)
Updated on 27 June 2018
File name
PIL_14956_689.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 08 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2018
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 09 December 2016
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 08 December 2016
File name
PIL_14956_689.pdf
Reasons for updating
- New PIL for new product
Updated on 08 December 2016
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 06 June 2016
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
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
Updated on 18 December 2015
Reasons for updating
- Change to date of revision
Updated on 19 August 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 08 May 2015
Reasons for updating
- Change to further information section
Updated on 17 September 2013
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 16 September 2013
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 06 July 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
Updated on 26 October 2011
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 08 April 2011
Reasons for updating
- New PIL for new product