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: 06/09/17

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Summary of Product Characteristics last updated on medicines.ie: 29/3/2019

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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 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 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 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 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 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.

 

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.