Fampridine Teva 10 mg, tabletten met verlengde afgifte

Riik: Holland

keel: hollandi

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

Toimeaine:

FAMPRIDINE 10 mg/stuk

INN (Rahvusvaheline Nimetus):

FAMPRIDINE 10 mg/stuk

Ravimvorm:

Tablet met verlengde afgifte

Koostis:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Manustamisviis:

Oraal gebruik

Loa andmise kuupäev:

2021-11-24

Infovoldik

Fampridine, DE/H/6564/001, 13.12.22
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rvg 126649 EU PIL IB-001 met NL info-tracked
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FAMPRIDINE TEVA 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 [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product 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.
[Product 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]:
-
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 PROB

Toote omadused

Fampridine, DE/H/6564/001, 13.12.22
1
2
rvg 126649 EU SPC IB-001 met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Fampridine Teva 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, biconvex oval shaped film-coated prolonged-release
tablets, debossed with R10 on
one side. No debossing on the other side
Dimensions: approximately 8 x 13 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product 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 [Product Name] 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). [Product Name] 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).
_Starting and Evaluating [Product 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
[Product 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, [Product
Name] should be
discontinued
•
[Product Name] should be discontinued if benefit is not reported by
patients.
_Re-Evaluating [Product Name] 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