Halcion 125 micrograms Tablets *
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
File name
DEC202054419_Reg SPC HAL 125 mcg 8_1 IE_clean_1597654370.pdf
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
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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.
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Updated on 23 December 2019
File name
DEC201972678_Reg SPC HAL 125 mcg 7_1 IE clean_1577109700.pdf
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
File name
DEC201972678_Reg PIL HAL 13_1 IE clean_1577109652.pdf
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
File name
DEC201915944_Reg SPC HAL 125 mcg 6_1 IE_clean_1553840514.pdf
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
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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 06 September 2017
File name
PIL_10769_416.pdf
Reasons for updating
- New PIL for new product
Updated on 06 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2017
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 06 September 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 08 August 2014
Reasons for updating
- Change of manufacturer
Updated on 08 July 2014
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 07 July 2014
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
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
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
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
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
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Change to MA holder contact details
Updated on 02 April 2012
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
Updated on 29 March 2012
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
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
Updated on 19 October 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 29 November 2010
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
Updated on 19 November 2010
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 25 August 2009
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
Updated on 28 August 2008
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
Reasons for updating
- Change to side-effects
Updated on 26 July 2006
Reasons for updating
- Change of manufacturer
Updated on 07 April 2006
Reasons for updating
- New PIL for medicines.ie