FIRDAPSE 10 mg Tablet

Зміст інструкції

1. FIRDAPSE 10 mg tablets
   1. What is FIRDAPSE and what is it 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

FIRDAPSE 10 mg tablets

amifampridine

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, as it could be dangerous.
If any side effects occur, including those not listed in this leaflet, tell your
doctor or pharmacist. See section 4.

Contents of 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 is FIRDAPSE and what is it used for

FIRDAPSE is used in adults to treat the symptoms of a neuromuscular disease called Lambert-Eaton myasthenic syndrome (LEMS). This condition affects the transmission of nerve impulses to the muscles, causing muscle weakness. It can be associated with certain types of cancer (paraneoplastic form of LEMS) or with the absence of such cancers (non-paraneoplastic form of LEMS).
In patients with this condition, a chemical substance called acetylcholine, which transmits nerve impulses to the muscles, is not released normally and the muscle does not receive, in whole or in part, nerve signals.
FIRDAPSE works by increasing the release of acetylcholine and promoting the reception of nerve signals by the muscles.

2. What you need to know before you take FIRDAPSE

Do not take FIRDAPSE
If you are allergic to amifampridine, or to any of the other ingredients of this medicine
(listed in section 6).
If you have uncontrolled asthma,
If you have epilepsy,
Together with medicines that may alter the electrical activity of the heart (prolongation of the
QT interval – detectable on an electrocardiogram), such as:
sultopride (a medicine prescribed for the treatment of certain behavioral disorders in adults),
an antiarrhythmic medicine (for example, disopyramide)
medicines for the treatment of digestive problems (for example, cisapride, domperidone)
medicines for the treatment of infections - antibiotics (for example, rifampicin) and antifungals (e.g.,
ketoconazole).
Together with medicines that have a therapeutic dose close to the maximum safe dose,
If you have congenital heart problems (congenital QT syndrome).
If in doubt, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking FIRDAPSE.
Tell your doctor if you have
Asthma
A history of convulsions
Kidney problems
Liver problems
The doctor will carefully monitor the effects of FIRDAPSE on you, and may adjust the dose of the
medicines you are taking. He or she will also ask you to have a cardiology check-up at the beginning of
treatment and then annually.
If you suffer from LEMS but not from tumors, before starting treatment the doctor will perform
a careful assessment of the potential risks of tumors associated with FIRDAPSE.
Tell all doctors you see that you are using FIRDAPSE.

Stop treatment and consult your doctor immediately in case of:
Convulsions
Asthma

Other medicines and FIRDAPSE
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
Some medicines can interact with FIRDAPSE when taken together. The following medicines
must not be taken in combination with FIRDAPSE:
Medicines that can alter the electrical activity of the heart (prolongation of the QT interval,
detectable on an electrocardiogram), for example, sultopride, disopyramide, cisapride, domperidone,
rifampicin and ketoconazole (see “Do not take FIRDAPSE”).
It is particularly important to tell your doctor if you are taking any of the following medicines or are
planning to start taking the following medicines:
Antimalarials (for example, halofantrine and mefloquine)
Tramadol (a painkiller)
Antidepressants – tricyclic antidepressants (for example, clomipramine, amoxapine), selective
serotonin reuptake inhibitors (for example, citalopram, dapoxetine) and atypical antidepressants (for
example, bupropion)
Medicines for mental disorders (for example, haloperidol, carbamazepine, chlorpromazine, clozapine)
Medicines for Parkinson's disease - anticholinergics (for example, triesilfenidil, mesylate), MAO-B inhibitors
(for example, selegiline, deprenyl), COMT inhibitors (for example, entacapone)
Medicine for the treatment of allergies - antihistamines (for example, terfenadine, astemizole,
cimetidine)
Medicines for muscle relaxation - (for example, mivacurium, pipercurium, succamethonium)
Sedatives (for example, barbiturates)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.>
FIRDAPSE should not be used during pregnancy. You should use effective contraception
during treatment. If the patient discovers she is pregnant during treatment, she should
immediately inform her doctor.
It is not known whether FIRDAPSE is excreted in human breast milk. You should discuss the risks and
benefits of continuing therapy with FIRDAPSE during breastfeeding with your doctor.

Driving and using machines
This medicine can cause drowsiness, dizziness, convulsions and blurred vision and may therefore
impair the ability to drive vehicles or use machines. Do not drive and do not use machines if you
experience these side effects.

3. How to take FIRDAPSE

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The dose to be taken is established by the doctor based on the intensity of the symptoms and some
genetic factors. This dose is suitable only for you.
The recommended initial dose is 5 mg of amifampridine (half a tablet) three times a day
(i.e. 15 mg per day). The doctor may gradually increase this dosage, slowly at first,
to 5 mg (half a tablet) four times a day (i.e. 20 mg per day). Afterwards, the doctor may
continue to increase the overall daily dose by adding 5 mg (half a tablet) to the
day, every 4 or 5 days.
The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at
intervals during the day). Overall daily doses greater than 20 mg must be divided
into separate doses (from two to four). The single dose must never exceed 20 mg (two tablets).
The tablets have a score line that allows them to be divided in half. Swallow the tablets
with some water and also ingest some food.

Patients with kidney and liver diseases:
Patients with kidney and liver diseases must use FIRDAPSE with caution. For patients
with moderate or severe kidney or liver problems, an initial daily dose of
FIRDAPSE of 5 mg (half a tablet) is recommended. For patients with mild kidney or liver problems, a
recommended initial daily dose of FIRDAPSE of 10 mg (5 mg twice a day) is recommended. In these
patients, the dose of FIRDAPSE must be increased more slowly, compared to patients who do not
complain of kidney or liver disorders: increase the dose by 5 mg every 7 days. In case of adverse
effects, you should consult your doctor, as it may be necessary to stop
increasing the dose.

If you take more FIRDAPSE than you should
If you take more FIRDAPSE than you should, you may experience vomiting or stomach pain. If you experience any
of these symptoms, consult your doctor or pharmacist immediately.

If you forget to take FIRDAPSE
If you forget to take FIRDAPSE, do not take a double dose to make up for the missed dose,
but continue the treatment according to the doctor's prescriptions.

If you stop taking FIRDAPSE
If you stop the treatment, you may experience symptoms such as fatigue, slow reflexes and constipation. Do not
stop the treatment without consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment and consult your doctor immediately in case of:
Convulsions
Asthma

Very common side effects that may affect more than 1 in 10 people are:
Tingling and numbness around the mouth and extremities (hands and feet)
Reduced sense of touch or reduced sensitivity
Nausea
Dizziness
Increased sweating, cold sweat

Common side effects that may affect up to 1 in 10 people are:
Stomach pain
Cold hands and feet

Other side effects:
The intensity and incidence of many side effects depends on the dose you are taking.
The following side effects have been reported, among others (frequency cannot be defined
based on available data):
Raynaud's syndrome (circulatory disorder affecting the fingers of the hands and feet)
Diarrhea
Convulsions
Cough, excessive or viscous mucus in the airways, asthma attacks in asthmatic patients or in
those who have had episodes of asthma in the past
Blurred vision
Heart rhythm disorders, fast or irregular heartbeat (palpitations)
Weakness, fatigue, headache
Anxiety, sleep disorders, drowsiness
Chorea (movement disorder), myoclonus (muscle spasm or contraction)
Increase in some liver enzymes (transaminases) revealed by blood tests

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store FIRDAPSE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The
expiry date refers to the last day of the month.
Do not store at a temperature above 30 °C. Store in the original packaging, to
protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FIRDAPSE contains
The active ingredient is amifampridine. Each tablet contains amifampridine phosphate equivalent
to 10 mg of amifampridine.
The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of FIRDAPSE and contents of the pack
White, round tablet, flat on one side, with a dividing line on the other side.
The tablet can be divided into two equal parts.
Perforated single-dose thermoformed blisters (with thermoformed aluminum-PVC/PVDC covering)
containing 10 tablets.
One carton contains 100 tablets, divided into 10 strips of 10 tablets each.

Marketing Authorisation Holder
SERB S.A.
Avenue Louise 480
1050 Brussels
Belgium

Manufacturers
EXCELLA GmbH & Co. KG
Nürnberger Strasse 12
90537 Feucht
Germany
SERB S.A.
Avenue Louise 480
1050 Brussels
Belgium
This medicinal product has been granted a marketing authorisation under “exceptional circumstances”. This means
that, due to the rarity of the disease, complete information on this
medicinal product could not be obtained.
The European Medicines Agency will annually review any new information on this
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.