Solian 50mg Tablets

  • Name:

    Solian 50mg Tablets

  • Company:
    info
  • Active Ingredients:

    Amisulpride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/05/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 10/5/2019

Click on this link to Download PDF directly

SANOFI

SANOFI

Company Products

Medicine NameActive Ingredients
Medicine Name Adenocor Active Ingredients Adenosine
Medicine Name Amaryl 1mg Tablets Active Ingredients Glimepiride
Medicine Name Amaryl 3mg Tablets Active Ingredients Glimepiride
Medicine Name Anthisan Cream Active Ingredients Mepyramine Maleate
Medicine Name Apidra 100 units/ml solution for injection in a cartridge Active Ingredients Insulin Glulisine
Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
Medicine Name Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen Active Ingredients Insulin Glulisine
Medicine Name Aprovel 150mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 300mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 75mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Arava 10 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arava 20 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Bisolvon Oral Solution Active Ingredients Bromhexine hydrochloride
Medicine Name Brolene 0.1%w/v Eye Drops Solution Active Ingredients Propamidine Isethionate
Medicine Name Brolene 0.15% w/w Eye Ointment Active Ingredients Dibromopropamidine Isethionate
Medicine Name Buscopan 10 mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Ampoules Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Rx 10mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Calcium Resonium Active Ingredients Calcium polystyrene sulfonate
Medicine Name Cerubidin 20mg Powder for Solution for Injection Active Ingredients daunorubicin hydrochloride
Medicine Name Cidomycin Paediatric 20mg/2ml Solution For Injection Active Ingredients Gentamicin sulfate
Medicine Name Claforan Powder for Solution for Injection 1g Active Ingredients Cefotaxime sodium
Medicine Name Claforan Powder for Solution for Injection 500mg Active Ingredients Cefotaxime sodium
Medicine Name Clexane 10,000 IU (100mg)/1ml Solution for Injection Active Ingredients Enoxaparin sodium
Medicine Name Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection Active Ingredients Enoxaparin sodium
1 - 0 of 178 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 10 May 2019 PIL

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 SmPC

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 14 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2017 SmPC

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 PIL

Reasons for updating

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

Updated on 19 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2016 SmPC

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 2 June 2016 PIL

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 PIL

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 SmPC

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 PIL

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 7 November 2014 SmPC

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 5 November 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 14 July 2014 SmPC

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 7 July 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 April 2013 PIL

Reasons for updating

  • Change of manufacturer
  • Change to marketing authorisation holder

Updated on 13 February 2013 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 October 2010 SmPC

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 4 October 2010 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 23 September 2009 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 31 August 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration

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 14 November 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 February 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie