Stemetil Tablets 5mg
*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 03 November 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Stemetil Tabs (3).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 Tabs (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 28 March 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Stemetil Tabs (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 Tabs.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 Tabs.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- 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 17 May 2022
File name
1.3.1 SPC Stemetil 5mg Tablets - clean.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 17 May 2022
File name
IE - Stemetil 5mg Tablets - 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 12 July 2021
File name
Leaflet Stemetil 5mg Tablets 07.2014.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
Leaflet Stemetil 5mg Tablets 07.2014.pdf
Reasons for updating
- XPIL Removed
Updated on 19 September 2018
File name
Leaflet Stemetil 5mg Tablets 07.2014.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 September 2018
File name
Stemetil 5mg Tablets. SPC.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 September 2018
File name
1.3.1.1 Stilnoct 5mg tablets SmPC.pdf
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
4.4.2 General information
General information relating to effects seen following administration of hypnotic agents which should be taken into account by the prescribing physician are described belowproducts and other forms of interaction and Ssection 4.8 Undesirable effects)
4.8 Undesirable effects
Uncommon: paraesthesia, tremor, disturbance in attention, speech disorder
Not knownRare: depressed level of consciousness, disturbance in attention, speech disorder.
Common: hHallucination, agitation, nightmare, depression (See Section 4.4)..
Uncommon: confusional state, irritability, restlessness, aggression, somnambulism (See Section 4.4), euphoric mood
Rare: libido disorder
Very rare: delusion, dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation).
Not kKnown: restlessness, aggression, delusion, anger, abnormal behaviour, somnambulism, (See section 4.4 Special warnings and precautions for use: Somnambulism and associated behaviours),dependence (drug withdrawal syndrome, or rebound effects may occur after treatment discontinuation), libido disorder, depression (see section 4.4), euphoric mood
Not knownRare: gait disturbance, drug tolerance, fall (predominantly in elderly patients and
Not known: drug toleranc
Not KnownVery rare: respiratory depression (see section 4.4)
Not known: muscular weakness
Not knownUncommon: rash, pruritus, urticariam hyperhidrosis.
Rare: urticari
Not knownUncommon: liver enzymes elevated
Rare: , hepatocellular, cholestatic or mixed liver injury (see Sections 4.2, Section and 4.3 and Section 4.5).
Updated on 22 August 2018
File name
1.3.2.1 Stilnoct 5mg 10mg PIL Quetigny.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- 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 18 May 2018
File name
Leaflet Stemetil 5mg Tablets 07.2014.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 March 2018
File name
PIL_13885_445.pdf
Reasons for updating
- New PIL for new product
Updated on 29 March 2018
Reasons for updating
- Improved presentation of PIL
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
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 16 April 2013
Reasons for updating
- Change of manufacturer
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 17 November 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 03 March 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 11 November 2008
Reasons for updating
- New PIL for medicines.ie
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 20 November 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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 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 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 07 December 2004
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 October 2003
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 July 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 June 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)