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Fampyra 10 mg prolonged-release tablets

*
Pharmacy Only: Prescription

  • Company:

    Merz Pharma UK Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Fampridine

    *Additional information is available within the SPC or upon request to the company

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Updated on 23 January 2025

File name

m1-3-1-spc-clean-10mg-Fampyra 10mg.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 23 January 2025

File name

PIL Jan 25 - Accorda Bridging stock.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 May 2022

File name

leaflet fampyra pdf..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

spc fampyra pdf..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.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.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.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.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.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.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.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

Multiple changes associated with change from 'conditional' to 'standard' marketing authorization.

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 to reflect renewal date.

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

Updates to sections 9 & 10 following renewal.

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 4.4, a warning to pay particular attention to patients with a history of allergic reactions has been added
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

Latest renewal date text removed. (section 9)

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 6.5 (Nature and contents of container)- Blister packs have been added
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

None provided

Updated on 22 September 2011

Reasons for updating

  • New PIL for new product

Merz Pharma UK Ltd

Merz Pharma UK Ltd