Fampyra 10 mg prolonged-release tablets * Pharmacy Only: Prescription
Company:
Biogen Idec 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 11 May 2022
File name
627b8f87d64ab.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 May 2022
File name
627b8eb590f5b.pdf
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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 20 December 2021
File name
Fampyra EU PIL Dec 2021_1639994569.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to uncommon side effects (trigeminal neuralgia) in section 4 of the PIL.
Updated on 20 December 2021
File name
Fampyra EU SmPC Dec 2021_1639994428.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- 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 the trigeminal neuralgia AE in section 4.8 and change to wording relating to marketed presentations in section 6.5 of the SmPC
Updated on 02 September 2020
File name
Fampyra SmPC UK & IRL_July 2020_1599061128.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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
Section 4.2 and 4.3 : Posology and method of administration / Contraindications |
Removal of the contraindication for mild renal impairment (creatinine clearance <50 ml/min). |
| 4.5 Interaction with other medicinal products and other forms of interaction | Typographical correction |
|
Section 4.8 : Undesirable effects |
Addition of Vertigo as an AE, frequency : common removal of text describing the adverse event :seizure |
|
Section 4.9 :Overdose
|
Addition of dizziness as a symptom of overdose
|
|
Section 5.2 Pharmacokinetic effects
|
Removal of text stating that there were insufficient numbers of subjects aged 65 and over to determine that they respond differently to Fampyra than younger patients |
Updated on 02 September 2020
File name
Fampyra PIL_UK & IRL_July 2020_1599060835.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Consequential changes to the PIL as a result of the LIBERATE update:
- Removal of contraindication for mild kidney problems
- Addition to vertigo as a common side effect
- Addition of dizziness as a symptom of overdose
Updated on 26 November 2019
File name
Fampyra PIL_UK & IRL_Nov 2019_1574766851.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Deletion of Biogen (Denmark) Manufacturing ApS as site responsible for the manufacture of the finished product.
Updated on 15 August 2018
File name
Fampyra PIL_UK & IRL_Aug 2018_1534327112.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 August 2018
File name
Fampyra SmPC UK & IRL_Aug 2018_1534327178.pdf
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
Change in MAH to Biogen Netherlands B.V.
Updated on 10 July 2018
File name
Fampyra_SmPC_UK_IRL_Jun 2018.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following undesirable effects have been added to the SmPC (with corresponding updates to section 4.4):
- Influenza (common)
- Nasopharyngitis (common)
- Viral infection (common)
Updated on 10 July 2018
File name
Fampyra_PIL_UK_IRL_Jun 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2017
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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Removal of black triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 June 2017
File name
PIL_15140_191.pdf
Reasons for updating
- New PIL for new product
Updated on 14 June 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Removal of black triangle
Updated on 28 June 2016
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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 28 June 2016
Reasons for updating
- Change to date of revision
Updated on 23 June 2016
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 12 April 2016
Reasons for updating
- Change to date of revision
Updated on 27 October 2015
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 20 October 2015
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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 06 November 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 26 August 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of renewal of authorisation
- 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 4.8, exacerbation of trigeminal neuralgia has been included as an uncommon side effect
- The opportunity has also been taken to update the contact details for IMB to HPRA, following the change of name of this organisation on July 1st 2014
- In Section 9, the date of latest renewal of the MA has been included
- In Section 10, the date of last revision of the SmPC text has been updated accordingly
Updated on 26 August 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 17 June 2014
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, the wording relating to the risk of falls has been updated as follows:
The increased incidence of dizziness and balance disorder seen with Fampyra in the first 4 to 8 weeks of treatment may result in an increased risk of falls. Therefore, Ppatients who are using should use walking aids should continue to use these aids as needed.
Updated on 17 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 17 July 2013
Reasons for updating
- Addition of black triangle
- 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
In Section 4.8, reports of serious hypersensitivity reactions have been added
The date of last revision of the text has been updated to 05/2013
Updated on 17 July 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of black triangle
Updated on 27 June 2012
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 June 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- 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 8 (Marketing authorisation number)- Additonal MA numbers for blister packs are now inclueded
In section 9 (Date of first authorisation./renewal of authorisation)- Renewal date added
In section 10 (Date of revision of text)- Date amended
Updated on 30 May 2012
Reasons for updating
- Change to packaging
- Change to date of revision
- Change of distributor details
Updated on 04 October 2011
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 2011
Reasons for updating
- New PIL for new product