Xermelo 250 mg film-coated tablets
- Name:
Xermelo 250 mg film-coated tablets
- Company:
Ipsen Pharmaceuticals Ltd
- Active Ingredients:
- 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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Ipsen Pharmaceuticals Ltd
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| Medicine Name Xermelo 250 mg film-coated tablets | Active Ingredients Telotristat ethyl |
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 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 SPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 SPC
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 SPC
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 SPC
Reasons for updating
- Previous version of SPC 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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC 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
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
Updated on 22 September 2017 PIL
Reasons for updating
- New PIL for new product