Halcion 250 microgram Tablets

  • Name:

    Halcion 250 microgram 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: 17/8/2020

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 232 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 17 August 2020 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 remove the previously approved wording in section 5.3 of the SmPC.

 

Effect of anesthetic and sedative drugs

Nonclinical research has shown that administration of anesthetic and sedation drugs that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity can increase neuronal cell death in the brain and result in long term deficits in cognition and behavior of juvenile animals when administered during the period of peak brain development. Based on comparisons across nonclinical species, the window of vulnerability of the brain to these effects is believed to correlate with human exposures in the third trimester of pregnancy through the first year of life, but may extend to approximately 3 years of age. While there is limited information of this effect with triazolam, since the mechanism of action includes potentiation of GABA activity, a similar effect may occur. The relevance of these nonclinical findings to human use is unknown.

 

 

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 11 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 11 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 11 September 2017 PIL

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

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

  • New PIL for new product

Updated on 8 July 2014 PIL

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

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.6, 4.8

 

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 10 June 2014 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 10 June 2014 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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.