Solian 400mg Film-Coated Tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 January 2023
File name
1.3.1 solian patient leafletS22.514.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 26 August 2022
File name
1.3.1 solian patient leaflet (1).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 26 August 2022
File name
1.3.1 solian 400mg tablets smpc (1).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2021
File name
1.3.1 solian patient leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
Updated on 17 December 2021
File name
1.3.1 solian 400mg tablets smpc.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 be renewed (B)
Updated on 15 September 2021
File name
1.3.1 solian 400mg tablets smpc IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 September 2021
File name
1.3.1 solian patient leaflet IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 27 August 2020
File name
703235 V4.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 10 May 2019
File name
PIL Solian IE653.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Updated on 10 May 2019
File name
SPC Solian 400mg tablets IE653 .pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.3 – deletion of lactation
4.4 – warning on liver toxicity
4.6 - update to pregnancy, lactation and fertility section
4.8 – addition of restless leg syndrome, hepatocellular injury, photosensitivity reactions, QT interval prolongation frequency change
5.3 – pre-clinical data updated
Updated on 20 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2017
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 July 2017
File name
PIL_9144_470.pdf
Reasons for updating
- New PIL for new product
Updated on 19 July 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 June 2016
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Musculoskeletal and connective tissue disorders:
Frequency not known: Osteopenia, osteoporosis.
Updated on 02 June 2016
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 31 May 2016
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 21 July 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: New paragraph 'Benign pituitary tumour' included.
Section 4.8: New paragraphs 'Endocrine disorders' and 'Metabolism and nutrition disorders' included.
Updated on 16 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 07 November 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Breast cancer:
Amisulpride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during amisulpride therapy.
Section 4.8 updated to include the new PV Legislation wording on adverse effect reporting.
Updated on 05 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
Updated on 14 July 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type II.C.1.4 variation to update section 4.8 of the SmPC following a revision to our Core Safety Data Sheet for amisulpride, CCDSv7.
Updated on 07 July 2014
Reasons for updating
- Change to side-effects
Updated on 18 April 2013
Reasons for updating
- Change of manufacturer
- Change to marketing authorisation holder
Updated on 13 February 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 August 2012
Reasons for updating
- Improved electronic presentation
Updated on 04 October 2010
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 October 2010
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 23 September 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 September 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 31 August 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 August 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 19 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 14 February 2006
Reasons for updating
- Improved electronic presentation
Updated on 14 October 2004
Reasons for updating
- New PIL for medicines.ie