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: 25/06/20

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Summary of Product Characteristics last updated on medicines.ie: 18/11/2020
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 18 November 2020

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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

The following sections were changed in the SmPC:

  • In section 5.3, the statement “Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development” is inconsistent with the non-clinical data previously provided to the EMA which showed reproductive toxicity. “Toxicity to reproduction and development” has been removed from this statement.
  • In section 6.3, the shelf life has been changed from 4 to 5 years.

Updated on 25 June 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

The following changes have been made in the SmPC:

In section 4.2, the statement "as no data are available" was removed from the "Hepatic Impairment" sub-heading

In section 5.2, additional information is provided under the sub-heading "Hepatic Impairment" following a study in subjects with severe hepatic impairment and in healthy subjects

Updated on 25 June 2020 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

Free text change information supplied by the pharmaceutical company

The following changes have been made in the PIL:

  • In Section 2, Warnings and Precautions, additional information is given on the use of the product in patients with liver problems
  • In Section 4, Possible side effects, the frequency of common and very common side effects has been added 

Updated on 29 April 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 29 April 2020

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Changes to SmPC due to a Type II variation for post-approval committments

SmPC sections affected:

4.2

4.4

4.5

4.8

4.9

5.2

6.3

10

Updated on 17 April 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

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

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

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

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Reasons for updating

  • Previous version of SmPC reinstated

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

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

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

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

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

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

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Updated on 7 January 2019

Reasons for updating

  • Change to section 6.3 - Shelf life

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

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 SPC

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 SPC

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