Stemetil Tablets 5mg

*
Pharmacy Only: Prescription
  • Company:

    SANOFI
  • Status:

    No Recent Update
  • 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 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

Reduction of shelf life form 60 to 36 months

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

Section 7 updated to include 'T/A SANOFI'

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

Update Section 4.6 & 4.8 in line with GLU & PhVWP.

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 4.3 - contraindicated for use in children
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

Update section
2 - addition of monohydrate
6.1 - addtion of monohydrate
10 - date of revision

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

Update Section 4.4 - addition of warning on use in people with stroke risk factors.

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)