Librium 5mg Hard Capsules
*Company:
Mylan IRE Healthcare LtdStatus:
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 05 February 2020
File name
ie-spc-librium-5mg-ccds-clean.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 05 February 2020
File name
ie-pl-librium-ccds-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 16 October 2018
File name
ie-pl-librium-clean-mahtransfer.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 October 2018
File name
ie-spc-librium-5mg-clean-mahtransfer.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 14 August 2018
File name
ie-pl-librium-cmdh-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 14 August 2018
File name
ie-spc-librium-5mg-cmdh-clean.pdf
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 August 2018
File name
ie-spc-librium-5mg-cmdh-clean.pdf
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2016
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
In section 4.2: Information regarding long-term use has been added. Information regarding tapering has been added. Information regarding paediatric and special patient groups has been added. Method of administration has been added.
In section 4.3: Contraindications have been added.
In section 4.4: warnings regarding severe personality disorder and dependency history has been added. Information regarding duration of treatment psychiatric and 'paradoxical' reactions has been added. Information regarding patients with severe renal or hepatic disease has been added. Information regarding loss or bereavement has been added.
In section 4.5: Information has been added in relation to interaction with other medicinal products and other forms of interaction
In section 4.6: Information reading use in pregnancy has been added. ADR reporting statement has been added.
In section 4.7: Information regarding effects on ability to drive and use machines has been added.
In section 4.8: Undesirable effects added.
In section 4.9: Information regarding overdose has been added.
In section 5.1: ATC code and Pharmacotherapeutic group added.
In section 5.3: Information regarding mutagenic and tumorigenic potential and reproductive toxicity added.
In section 10: The date of revision
Updated on 26 October 2016
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: Information regarding long-term use has been added. Information regarding tapering has been added. Information regarding paediatric and special patient groups has been added. Method of administration has been added.
In section 4.3: Contraindications have been added.
In section 4.4: warnings regarding severe personality disorder and dependency history has been added. Information regarding duration of treatment psychiatric and 'paradoxical' reactions has been added. Information regarding patients with severe renal or hepatic disease has been added. Information regarding loss or bereavement has been added.
In section 4.5: Information has been added in relation to interaction with other medicinal products and other forms of interaction
In section 4.6: Information reading use in pregnancy has been added. ADR reporting statement has been added.
In section 4.7: Information regarding effects on ability to drive and use machines has been added.
In section 4.8: Undesirable effects added.
In section 4.9: Information regarding overdose has been added.
In section 5.1: ATC code and Pharmacotherapeutic group added.
In section 5.3: Information regarding mutagenic and tumorigenic potential and reproductive toxicity added.
In section 10: The date of revision
Updated on 19 September 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
In section 10: the date of revision has changed
Updated on 19 September 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed
Updated on 28 September 2012
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
In section 10: date of revision has changed
Updated on 28 September 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: date of revision has changed
Updated on 09 March 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
In section 10: the date of revision has changed to Feb 2011
Updated on 09 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 04 September 2009
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 September 2009
Reasons for updating
- New SPC for medicines.ie