Fampridine Sandoz 10 mg, tabletten met verlengde afgifte

Երկիր: Նիդերլանդեր

Լեզու: հոլանդերեն

Աղբյուրը: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ակտիվ բաղադրիչ:

FAMPRIDINE 10 mg/stuk

INN (Միջազգային անվանումը):

FAMPRIDINE 10 mg/stuk

Դեղագործական ձեւ:

Tablet met verlengde afgifte

Կազմը:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K100M (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K100M (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K15M, K100M (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Կառավարման երթուղին:

Oraal gebruik

Հաստատման ամսաթիվը:

1900-01-01

Տեղեկատվական թերթիկ

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Sandoz B.V.
Fampridine Sandoz 10 mg, tabletten met verlengde afgifte
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RVG
125462
1313-v5
1.3.1.3 Bijsluiter
maart 2023
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
FAMPRIDINE SANDOZ 10 MG, TABLETTEN MET
VERLENGDE AFGIFTE
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
–
if you are
ALLERGIC
to fampridine or any of the other ingredients of this medicine (listed
in
section 6)
–
if

Ապրանքի հատկությունները

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Fampridine Sandoz 10 mg, tabletten met verlengde afgifte
RVG 125462
1311-v4
1.3.1.1 Samenvatting van de productkenmerken
maart 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fampridine Sandoz 10 mg, tabletten met verlengde afgifte
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 colored, approx. 13 mm x 8 mm, oval shaped film
coated tablets debossed with
“L10” on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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 [Nationally completed name] 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
[Nationally completed name]
•
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
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Fampridine Sandoz 10 mg, tabletten met verlengde afgifte
RVG 125462
1311-