FAMPYRA 10 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

FAMPRIDINE

Tillgänglig från:

MEDISON PHARMA LTD

ATC-kod:

N07XX07

Läkemedelsform:

TABLETS PROLONGED RELEASE

Sammansättning:

FAMPRIDINE 10 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

BIOGEN IDEC LTD, UK

Terapeutisk grupp:

FAMPRIDINE

Terapiområde:

FAMPRIDINE

Terapeutiska indikationer:

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

Tillstånd datum:

2017-03-31

Bipacksedel

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FAMPYRA 10 MG
PROLONGED-RELEASE TABLETS
ACTIVE INGREDIENT:
EACH TABLET CONTAINS: fampridine 10 mg
INACTIVE INGREDIENTS AND ALLERGENS: See section 6 (Additional
information).
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine.
•
If you have any further questions, consult your doctor or pharmacist.
•
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
FAMPYRA is intended to improve walking in adult patients with multiple
sclerosis suffering from walking
problems (EDSS 4-7).
THERAPEUTIC GROUP: pyridine isomer, potassium channel blocker.
In multiple sclerosis, inflammatory process destroys the protective
myelin sheath around
the neurons (nerve cells) leading to muscle weakness, muscle stiffness
and difficulty
walking. FAMPYRA belongs to a group of medicines blocking potassium
channels; these
medicines prevent potassium from leaving the neurons which have been
damaged by
multiple sclerosis, thus enabling signal passage in the neurons and
allowing improvement
of walking.
2.
BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
you are SENSITIVE (allergic) to fampridine or any of the other
ingredients of this
medicine (see section 6)
•
you currently suffer or have ever suffered from SEIZURES
•
you suffer from MODERATE TO SEVERE KIDNEY PROBLEMS
•
you are taking a medicine containing the active ingredient cimetidine
•
you are taking any OTHER MEDICINE CONTAINING FAMPRIDINE. This may
increase your
risk of serious side effects.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING FAMPYRA, TELL YOUR DOCTOR OR PHARMACIST IF:
•
you feel your heartbeats (palpitations).
•
you are prone to infections.
•
you need a walkin

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
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 Fampyra 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). Fampyra 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 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, Fampyra
should be discontinued
•
Fampyra 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 Fampyra (see above). The
re-evaluation should include withdrawal of
Fampyra and performing an assessment of walking ability. Fampyra
should be discontinued if patients
2
no longer receive walking benefit.
Missed Dose
The usual dosing regimen should always b