Fampyra
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-05-2022
Produktets egenskaber
(SPC)
05-05-2022
Offentlige vurderingsrapport
(PAR)
23-08-2017
Aktiv bestanddel:
Fampridine
Tilgængelig fra:
Biogen Netherlands B.V.
ATC-kode:
N07XX07
INN (International Name):
fampridine
Terapeutisk gruppe:
Other nervous system drugs
Terapeutisk område:
Multiple Sclerosis
Terapeutiske indikationer:
Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).
Produkt oversigt:
Revision: 16
Autorisation status:
Authorised
Autorisation dato:
2011-07-20
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
FAMPYRA 10 MG PROLONGED-RELEASE TABLETS
fampridine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fampyra is and what it is used for
2.
What you need to know before you take Fampyra
3.
How to take Fampyra
4.
Possible side effects
5.
How to store Fampyra
6.
Contents of the pack and other information
1.
WHAT FAMPYRA IS AND WHAT IT IS USED FOR
Fampyra contains the active substance fampridine which belongs to a
group of medicines called
potassium channel blockers. They work by stopping potassium leaving
the nerve cells which have
been damaged by MS. This medicine is thought to work by letting
signals pass down the nerve more
normally, which allows you to walk better.
Fampyra is a medicine used to improve walking in adults (18 years and
over) with Multiple Sclerosis
(MS) related walking disability. In multiple sclerosis, inflammation
destroys the protective sheath
around the nerves leading to muscle weakness, muscle stiffness and
difficulty walking.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMPYRA
DO NOT TAKE FAMPYRA
−
if you are
ALLERGIC
to fampridine or any of the other ingredients of this medicine (listed
in
section 6)
−
if you have a seizure or have ever had a
SEIZURE
(also referred to as a fit or convulsion)
−
if your doctor or nurse has told you that you have moderate or severe
KIDNEY PROBLEMS
−
if you are taking a medicine called cimetidine
−
if you are
TAKING ANY OTHER MEDICINE CONTAINING FAMPRIDINE
. This m
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fampyra 10 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 10 mg of fampridine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
An off-white, film coated, oval biconvex 13 x 8 mm tablet with flat
edge debossed with A10 on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fampyra is indicated for the improvement of walking in adult patients
with multiple sclerosis with
walking disability (EDSS 4-7).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with fampridine is restricted to prescription and
supervision by physicians experienced in
the management of MS.
Posology
The recommended dose is one 10 mg tablet, twice daily, taken 12 hours
apart (one tablet in the
morning and one tablet in the evening). Fampridine should not be
administered more frequently or at
higher doses than recommended (see section 4.4). The tablets should be
taken without food
(see section 5.2).
_Missed dose _
The usual dosing regimen should always be followed. A double dose
should not be taken if a dose is
missed.
Starting and evaluating Fampyra treatment
•
Initial prescription should be limited to two to four weeks of therapy
as clinical benefits should
generally be identified within two to four weeks after starting
Fampyra
•
An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW)
or Twelve Item
Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate
improvement
within two to four weeks. If no improvement is observed, the treatment
should be discontinued
•
This medicinal product should be discontinued if benefit is not
reported by patients.
_ _
Re-evaluating Fampyra treatment
If decline in walking ability is observed, physicians should consider
an interruption to treatment in
order to reassess the benefits of fampridine (see above). The
re-evaluation should include withdrawal
3
of this medicinal produc
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