Fampridine Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Fampridine

Διαθέσιμο από:

Accord Healthcare S.L.U.

Φαρμακολογική κατηγορία (ATC):

N07XX07

INN (Διεθνής Όνομα):

fampridine

Θεραπευτική ομάδα:

Other nervous system drugs

Θεραπευτική περιοχή:

Multiple Sclerosis

Θεραπευτικές ενδείξεις:

Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). 

Περίληψη προϊόντος:

Revision: 1

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2020-09-24

Φύλλο οδηγιών χρήσης

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
FAMPRIDINE ACCORD 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 Fampridine Accord is and what it is used for
2.
What you need to know before you take Fampridine Accord
3.
How to take Fampridine Accord
4.
Possible side effects
5.
How to store Fampridine Accord
6.
Contents of the pack and other information
1.
WHAT FAMPRIDINE ACCORD IS AND WHAT IT IS USED FOR
Fampridine Accord 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.
Fampridine Accord 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 FAMPRIDINE ACCORD
DO NOT TAKE
FAMPRIDINE ACCORD
−
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 ta

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fampridine Accord 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.
White to off white, oval shaped, biconvex, bevel-edged, film coated
tablets, approximately
13.1 x 8.1 mm in dimensions, debossed with ‘FH6’ on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fampridine Accord 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 Fampridine Accord 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
Fampridine Accord.
•
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.
_ _
3
_Re-evaluating Fampridine Accord treatment _
If decline in walking ability is observed, physicians should consider
an interruption to t