Firdapse (previously Zenas)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

amifampridine

Saatavilla:

SERB SA

ATC-koodi:

N07XX05

INN (Kansainvälinen yleisnimi):

amifampridine

Terapeuttinen ryhmä:

Other nervous system drugs

Terapeuttinen alue:

Lambert-Eaton Myasthenic Syndrome

Käyttöaiheet:

Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Tuoteyhteenveto:

Revision: 21

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-12-23

Pakkausseloste

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIRDAPSE 10 MG TABLETS
amifampridine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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 FIRDAPSE is and what it is used for
2.
What you need to know before you take FIRDAPSE
3.
How to take FIRDAPSE
4.
Possible side effects
5.
How to store FIRDAPSE
6.
Contents of the pack and other information
1.
WHAT FIRDAPSE IS AND WHAT IS IT USED FOR
FIRDAPSE is used to treat symptoms of a disease of the nerves and the
muscles called Lambert-Eaton
myasthenic syndrome or LEMS in adults. This disease is a disorder
affecting the transmission of nerve
impulses to muscles, resulting in muscle weakness. It can be
associated with certain tumour types
(paraneoplastic form of LEMS) or in the absence of these tumours
(non-paraneoplastic form of
LEMS).
In patients suffering from this disease, a chemical substance called
acetylcholine, which communicates
nerve impulses to muscles is not released normally and the muscle
doesn't receive some or all of the
nerve's signals.
FIRDAPSE works by increasing the release of acetylcholine and helps
the muscle to receive the nerve
signals.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FIRDAPSE
DO NOT TAKE FIRDAPSE
If you are allergic to amifampridine, or any of the other ingredients
of this medicine (listed in

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
FIRDAPSE 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amifampridine phosphate equivalent to 10 mg of
amifampridine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round tablet, flat-faced on one side and scored on the other
side.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of the
disease.
Posology
FIRDAPSE should be given in divided doses, three or four times a day.
The recommended starting
dose is 15 mg amifampridine a day, which can be increased in 5 mg
increments every 4 to 5 days, to a
maximum of 60 mg per day. No single dose should exceed 20 mg.
Tablets are to be taken with food. Please see section 5.2 for further
information about bioavailability
of amifampridine in the fed and fasted state.
If treatment is discontinued, patients may experience some of the
symptoms of LEMS.
_Renal or hepatic impairment _
FIRDAPSE should be used with caution in patients with renal or hepatic
impairment. A starting dose
of 5 mg amifampridine (half tablet) once per day is recommended in
patients with moderate or severe
impairment of renal or hepatic function. For patients with mild
impairment of renal or hepatic
function, a starting dose of 10 mg amifampridine (5 mg twice a day)
per day is recommended. Patients
should be titrated more slowly than those without renal or hepatic
impairment with doses increased
in 5 mg increments every 7 days. If any adverse reaction