Amifampridine SERB

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

amifampridine phosphate

Available from:

SERB SA

ATC code:

N07XX05

INN (International Name):

amifampridine

Therapeutic group:

Other nervous system drugs

Therapeutic area:

Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2022-05-19

Patient Information leaflet

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIFAMPRIDINE SERB 10 MG TABLETS
amifampridine
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 Amifampridine SERB is and what it is used for
2.
What you need to know before you take Amifampridine SERB
3.
How to take Amifampridine SERB
4.
Possible side effects
5.
How to store Amifampridine SERB
6.
Contents of the pack and other information
1.
WHAT AMIFAMPRIDINE SERB IS AND WHAT IT IS USED FOR
Amifampridine SERB contains the active substance amifampridine.
Amifampridine SERB 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.
Amifampridine SERB 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 AMIFAMPRIDINE SERB
DO NOT TAKE AMIFAMPRIDINE SERB
If you are allergic to amifampridine, or any of the other ingredients
of this medicine (listed in
section 6).
If you have uncontrolled asthma
If you are e

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amifampridine SERB 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 of approximately 10 mm, flat-faced on one side and
scored on the other side.
The tablet can be divided into equal doses.
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
Amifampridine SERB 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 _
Amifampridine SERB 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 occurs, upward dose
titration should be discontinued (see sections 4.4 and 5.2).
_Paediatric population_
The safety and efficacy of Amifampridine SERB in children aged 0 to 17
years has not been
establish