Halcion 250 microgram Tablets
- Name:
Halcion 250 microgram Tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- 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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Pfizer Healthcare Ireland
Company Products
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
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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 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
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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 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.