Xermelo 250 mg film-coated tablets

  • Name:

    Xermelo 250 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Telotristat ethyl

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/11/19

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Summary of Product Characteristics last updated on medicines.ie: 28/11/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

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Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
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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 28 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Update to section 4 to include nausea as a very common adverse event, depression as a common adverse event and bowel obstruction as an uncommon adverse event.

Update to section 6 to update local representative addresses

Updated on 28 November 2019 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 to update wording for depression and depressive disorders

Update to section 4.8 to include the following adverse events: depression and depressed mood as common, nausea as very common and intestinal obstruction as uncommon.

Updated on 21 November 2019 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Update to section 5.1 to include clinical data from Telepath extension study

Updated on 20 November 2019 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 20 November 2019 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

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

Updated on 20 November 2019 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 20 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update to section 2 of the PIL to include additional warning for hepatic impairment.

Updated on 20 November 2019 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Update to section 5.2 of the SmPC to include additional information on hepatic impairment from extension to the Telepath study

Updated on 6 June 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 May 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Sections 4.2 and 5.2 of the SmPC updated with data from renal impairment study. Faecaloma has also been added as a new ADR to section 4.8.

Updated on 20 May 2019 PIL

Reasons for updating

  • XPIL Created

Updated on 26 April 2019 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic 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 5.2 (Pharmacokinetic properties) data on drug-drug interaction was added.

In section 5.3 (Preclinical safety data) carcinogenicity data was added.

Updated on 19 March 2019 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 7 January 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change to section 6.3 - Shelf life

Updated on 13 May 2018 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 5 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 February 2018 SmPC

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

shelf-life extension from 30 to 36 months

Updated on 2 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 September 2017 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 22 September 2017 PIL

Reasons for updating

  • New PIL for new product