Librium 5mg Hard Capsules *
Pharmacy Only: Prescription

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 05 February 2020

File name

ie-spc-librium-5mg-ccds-clean_1580914356.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_1580914270.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_1539695039.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_1539695080.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_1534246164.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 August 2018

File name

ie-spc-librium-5mg-cmdh-clean_1534261571.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_1534246204.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

  • 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

  • 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

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

Free text change information supplied by the pharmaceutical company

In section 6.3: the shelf life has been reduced from 5 years to 2 years
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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.3: the shelf life has been reduced from 5 years to 2 years
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 4.4: additional warning added
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 4.4: additional warning added
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 7: the address of the MAH hs changed
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 7: the address of the MAH hs changed
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

Free text change information supplied by the pharmaceutical company

None provided

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

None provided