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Halcion 125 micrograms Tablets

  • Name:

    Halcion 125 micrograms Tablets

  • Company:
    info
  • Active Ingredients:

    Triazolam

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/12/19

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Summary of Product Characteristics last updated on medicines.ie: 23/12/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 227 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 23 December 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 29 March 2019 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: to update to section 5.3 Preclinical safety data – (Addition of Effect of anesthetic and sedative drugs)

Updated on 6 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 September 2017 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 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

SPC: Sections 4.4, 4.5 and 5.3

Addition of warning (section 4.4) and drug interaction text (section 4.5) related to benzodiazepine/opioid interaction.

Addition of preclinical information related to carcinogenicity, mutagenesis, and impairment of fertility in section 5.3 of triazolam CDS.

Updated on 6 September 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 8 August 2014 PIL

Reasons for updating

  • Change of manufacturer

Updated on 8 July 2014 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 - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.6, 4.8

Updated on 7 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 10 June 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Updates to sections:

2.      Qualitative and quantitative composition 

Section updated in line with QRD Version 9

4.2       Posology and method of administration                                                                                                                                 

Section updated in line with QRD Version 9

4.3.     Contraindications


Section updated to include new contraindications in line with CDS.

4.4.     Special warnings and precautions for use


Section updated in line with QRD Version 9

4.5. Interaction with other medicinal products and other forms of interaction


Statement on HIV protease inhibitors revised in line with CDS.

4.6. Fertility, pregnancy and lactation

Section updated in line with QRD Version 9

4.8    Undesirable effects

Section updated in line with QRD Version 9 and IMB details updated.

5.1       Pharmacodynamic properties

Section updated in line with QRD Version 9

6.6       Special precautions for disposal and other handling

Section updated in line with QRD Version 9 and IMB details updated.

Updated on 28 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Improved electronic presentation

Updated on 30 August 2012 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7:  update to the MA Holder Details

Section 8:  update to the MA Numbers

Section 10: update to the approval date

Updated on 28 August 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 2 April 2012 SmPC

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 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC update to sections 4.1 – 4.9

Updated on 29 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 20 October 2011 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 19 October 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 29 November 2010 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change due to user-testing of patient information

Updated on 19 November 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 25 August 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1 - formatting changes

Updated on 28 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 July 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 7 April 2006 PIL

Reasons for updating

  • New PIL for medicines.ie