Stemetil Tablets 5mg

  • Name:

    Stemetil Tablets 5mg

  • Company:
    info
  • Active Ingredients:

    Prochlorperazine maleate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/09/18

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Summary of Product Characteristics last updated on medicines.ie: 19/9/2018

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SANOFI

SANOFI

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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 19 September 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 19 September 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Updated on 17 September 2018 SmPC

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 PIL

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 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 29 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 14 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 14 March 2018 SmPC

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 8 November 2016 SmPC

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 6 August 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

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 November 2013 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 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 6 November 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 April 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 21 November 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 September 2012 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 3 March 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 11 November 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 September 2008 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 7 December 2004 SmPC

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 6 October 2003 SmPC

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 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 June 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 11 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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