Solian 100mg Tablets *
Pharmacy Only: Prescription

  • Company:

    SANOFI
  • Status:

    Updated
  • Legal 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

63d3abada3de2.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

63088c09297a5.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

63088bdb6b3cd.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_1640009933.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 100mg tablets smpc_1639737951.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 100mg tablets smpc IE_1631693419.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_1631693381.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_1598524604.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_1557490491.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 100mg tablets IE653 _1557491553.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 12 May 2018

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

  • 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

Type II.C.1.4 Align SmPC and Labelling with CCDSv12

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

 

4.7       Effects on ability to drive and use machines

 

Even when used as recommended, amisulpride may cause somnolence and blurred vision so that the ability to drive vehicles or operate machinery can be impaired (see section 4.8 Undesirable Effects).



4.8

Addition of:

 

-             Eye Disorders

Frequency not known: blurred vision.

-             Respiratory, thoracic and mediastinal disorders:

Frequency not known: Nasal congestion.

-             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 20 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 4.3: References to others sections included.
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

Section 4.4 updated to include the following new paragraph:

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 08 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

Type II.C.I.3.b - SPC update 4.4, 4.6, 4.8 to CCSI v6.

Updated on 24 August 2012

Reasons for updating

  • Improved electronic presentation

Updated on 05 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

Section. 2: Quantitative declaration for lactose monohydrate
Section. 4.4: Special warnings and precautions for use - Prolongation of the QT interval - Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and concomitant use with neuroleptics should be avoided.  Warning also added for Venous thromboembolism.

Updated on 04 October 2010

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 21 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

Section 4.4 - Addition of warnings regarding elderly patients with dementia and venous thromboembolism.
Section 4.8 - Addition of venous thromboembolism

Updated on 16 September 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 31 August 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

The changes are minor typographical amendments.

Updated on 05 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