Fampyra 10 mg prolonged-release tablets
- Name:
Fampyra 10 mg prolonged-release tablets
- Company:
Biogen Idec 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: 02/09/20
(Click to Download)XPIL
Package leaflet: information for the user
Package leaflet: information for the user
1. What Fampyra is and what it is used for
1. What Fampyra is and what it is used for
2. What you need to know before you take Fampyra
2. What you need to know before you take Fampyra
3. How to take Fampyra
3. How to take Fampyra
4. Possible side effects
4. Possible side effects
5. How to store Fampyra
5. How to store Fampyra
6. Contents of the pack and other information
6. Contents of the pack and other information
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Biogen Idec Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AVONEX 30 micrograms/0.5 ml solution for injection | Active Ingredients Interferon beta-1a |
| Medicine Name AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen | Active Ingredients Interferon beta-1a |
| Medicine Name Fampyra 10 mg prolonged-release tablets | Active Ingredients Fampridine |
| Medicine Name Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen | Active Ingredients peginterferon beta-1a |
| Medicine Name Spinraza 12 mg solution for injection | Active Ingredients Nusinersen sodium |
| Medicine Name Tecfidera 120mg and 240mg gastro-resistant hard capsules | Active Ingredients Dimethyl fumarate |
| Medicine Name Tysabri 300mg concentrate for solution for infusion | Active Ingredients Natalizumab |
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 2 September 2020 SPC
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 2 September 2020 PIL
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 PIL
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 August 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 June 2017 SPC
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 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 4.6 - 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 PIL
Reasons for updating
- New PIL for new product
Updated on 14 June 2017 PIL
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 PIL
Reasons for updating
- Change to date of revision
Updated on 28 June 2016 SPC
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 23 June 2016 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 12 April 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 27 October 2015 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 20 October 2015 SPC
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 6 November 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 26 August 2014 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 17 July 2013 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of black triangle
Updated on 27 June 2012 SPC
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 6 June 2012 SPC
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 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
- Change of distributor details
Updated on 4 October 2011 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 2011 PIL
Reasons for updating
- New PIL for new product