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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 11/09/2017
SPC Halcion 250 microgram Tablets

When a pharmaceutical company changes an SPC or PIL, 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 11/09/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Sep-2017
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 08/07/2014 and displayed until 11/09/2017
Reasons for adding or 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
Date of revision of text on the SPC:   01-Jul-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Update to sections 4.4, 4.6, 4.8

 

Updated on 10/06/2014 and displayed until 08/07/2014
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

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.

 

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Active Ingredients

 
   Triazolam