Fampridine Rontis 10mg Prolonged-Release Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

FAMPRIDINE

זמין מ:

Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece

קוד ATC:

N07XX07

INN (שם בינלאומי):

FAMPRIDINE 10 mg

טופס פרצבטיות:

PROLONGED-RELEASE TABLET

הרכב:

FAMPRIDINE 10 mg

סוג מרשם:

POM

איזור תרפויטי:

OTHER NERVOUS SYSTEM DRUGS

מצב אישור:

Authorised

תאריך אישור:

2020-08-05

עלון מידע

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FAMPRIDINE RONTIS 10MG 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 Rontis is and what it is used for
2.
What you need to know before you take Fampridine Rontis
3.
How to take Fampridine Rontis
4.
Possible side effects
5.
How to store Fampridine Rontis
6.
Contents of the pack and other information
1.
WHAT FAMPRIDINE RONTIS IS AND WHAT IT IS USED FOR
Fampridine Rontis 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.
Fampridine Rontis 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 FAMPRIDINE RONTIS
DO NOT TAKE FAMPRIDINE RONTIS:
−
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 you have
KIDNEY PROBLEMS
−
if you are taking a medicine called cimetidine
−
if you are
TAKING ANY OTHER MEDICI

מאפייני מוצר

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fampridine Rontis
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.
Off-white, film coated, oval biconvex 13.2 x 8.2 mm tablet with flat
edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fampridine Rontis 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 Rontis
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 Rontis
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
Fampridine Rontis
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 Rontis.
•
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, Fampridine Rontis should be
discontinued.
•
Fampridine Rontis should be discontinued if benefit is not reported by
patients.
Re-evaluating Fampridine Rontis treatment
If decline in walking ability is observed, physicians should consider
an interruption to treatment in order to
reassess the benefits of Fampridine Rontis (see above). The
re-evaluation should include withdrawal of
Fampridine Rontis and performing an assessment of walking ability.
Fampridine Rontis should be
discontinu