Halcion 250 microgram Tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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
Updated on 16 October 2024
File name
Reg SPC HAL 250 mcg 14_0 IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2024
File name
Reg PIL HAL 21_0 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 05 December 2023
File name
Reg PIL HAL 20_0 IE clean consolidated.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 04 December 2023
File name
Reg PIL HAL 19_1 IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 15 November 2023
File name
Reg PIL HAL 18 1 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 15 November 2023
File name
Reg SPC HAL 250mcg 13 1 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 November 2023
File name
Reg SPC HAL 250mcg 13 1 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 November 2023
File name
Reg SPC HAL 250mcg 13 1 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 February 2023
File name
Reg SPC HAL 250 mcg 12_0 IE Clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 February 2023
File name
Reg PIL HAL 17_1 IE Clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 25 January 2023
File name
RegSPCHAL250mcg111IEClean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 January 2023
File name
RegPILHAL161IEClean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 February 2022
File name
Reg SPC HAL 250mcg 101 IE Clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 February 2022
File name
Reg PIL HAL 151 IE Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 17 August 2020
File name
DEC202054419_Reg SPC HAL 250 mcg 8_1 IE_clean.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 250 mcg 7_1 IE clean.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.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 250 mcg 6_1 IE_clean.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
|
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 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 11 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
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
File name
PIL_10769_416.pdf
Reasons for updating
- New PIL for new product
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 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
Free text change information supplied by the pharmaceutical company
Update to sections 4.4, 4.6, 4.8
Updated on 10 June 2014
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
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.