Stemetil 12.5mg/ml Solution for Injection
*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 09 January 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Stemetil Injection.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 03 November 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Stemetil injection (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 03 November 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Stemetil Injection (2).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 03 November 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Stemetil injection (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 28 March 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Stemetil Injection (1).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Stemetil Injection.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Stemetil injection.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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
Updated on 03 March 2023
File name
IE - Stemetil 12.5mg injection - PIL Text.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 03 March 2023
File name
1.3.1 SPC Stemetil Injection.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 December 2022
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Stemetil Injection (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 25 October 2022
File name
1.3.1 SPC Stemetil Injection - clean (1).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 May 2022
File name
IE - Stemetil 12.5mg imjection - PIL Text - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 03 May 2022
File name
IE - Stemetil 12.5mg imjection - PIL Text - clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 July 2021
File name
PIL_8410_240.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
PIL_8410_240.pdf
Reasons for updating
- XPIL Removed
Updated on 14 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 March 2018
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.5 added:-
Phenothiazines are potent inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co-administration of phenothiazines with amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/amitriptylinoxide.
Updated on 08 November 2016
Reasons for updating
- Change to section 6.3 - Shelf life
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 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
Bulk Type II C.I.4 No. variation to update the product information (SPC Section 4.8) following the publication of Prochlorperazine Global Labelling Update Version 7.
Updated on 30 July 2014
File name
PIL_8410_240.pdf
Reasons for updating
- New PIL for new product
Updated on 30 July 2014
Reasons for updating
- Change to side-effects
Updated on 08 November 2013
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 No. C.I.4 to update the SPC section 4.8 in line with Prochlorperazine GLU v6. Section 4.8 is also updated in line with the implementation of the recent PV legislation
Updated on 06 November 2013
Reasons for updating
- Change to side-effects
Updated on 30 September 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 21 November 2012
Reasons for updating
- Improved electronic presentation
Updated on 26 September 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 15 February 2012
Reasons for updating
- 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 04 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 26 February 2010
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - warnings on use in patients with renal dysfunction, parkinsons disease, cardiac failure, myasthenia gravis, seizures, elderly patients with dementia, VTE etc.
Section 4.5 - additional interactions
Section 4.6 - warning on use in pregnancy
Section 4.7 - revision of statement on driving & drowsiness
Section 4.8 - revision of section on adverse reactions
Section 4.9 - administrative changes
Updated on 25 February 2010
Reasons for updating
- Improved electronic presentation
Updated on 23 September 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 July 2008
Reasons for updating
- Change of manufacturer
Updated on 23 November 2007
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 November 2007
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
6.1 - Addition of e numbers
Updated on 19 November 2007
Reasons for updating
- Addition of marketing authorisation holder
Updated on 21 May 2007
Reasons for updating
- 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 19 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 14 December 2005
Reasons for updating
- Improved electronic presentation
Updated on 17 November 2005
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 16 February 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 February 2005
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 be renewed (B)
Updated on 19 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 12 May 2004
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)