AMIFAMPRIDINA 10 mg Tabletka

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1. Amifampridina Accord 10 mg tablets
   1. What is Amifampridina Accord and what it is used for
   2. What you need to know before taking Amifampridina Accord
   3. How to take Amifampridina Accord
   4. Possible side effects
   5. How to store Amifampridina Accord
   6. Contents of the pack and other information

Amifampridina Accord 10 mg tablets

amifampridina

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amifampridina Accord is and what it is used for
• 2. What you need to know before you take Amifampridina Accord
• 3. How to take Amifampridina Accord
• 4. Possible side effects
• 5. How to store Amifampridina Accord
• 6. Contents of the pack and other information

1. What is Amifampridina Accord and what it is used for

Amifampridina Accord is used in adults to treat the symptoms of a disease of the nerves and muscles 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.
Amifampridina Accord works by increasing the release of acetylcholine and promoting the reception of nerve signals by the muscles.

2. What you need to know before taking Amifampridina Accord

Do not take Amifampridina Accord

• If you are allergic to amifampridina, or to any of the other ingredients of this medicine (listed in section 6)
• If you suffer from uncontrolled asthma
• If you have epilepsy
• Together with medicines that may alter the electrical activity of the heart (QT interval prolongation – detectable with an electrocardiogram), such as:
  o Sultopride (a medicine prescribed for the treatment of certain behavioral disorders in
  adults)
  o Antiarrhythmic medicine (e.g., disopyramide)
  o Medicines for the treatment of digestive problems (e.g., cisapride, domperidone)
  o Medicines for the treatment of infections - antibiotics (e.g., rifampicin) and
  antifungals (e.g., ketoconazole)

Prolonged– detectable with electrocardiogram), such as:
o Sultropride (a medicine prescribed for the treatment of some behavioral disorders in
adults)
o Antiarrhythmic medicine (for example, disopyramide)
o Medicines for the treatment of digestive problems (for example, cisapride, domperidone)
o 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 you have any doubts, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amifampridina Accord

• Tell your doctor if you have Asthma
• A history of seizures (convulsions)
• Liver problems
• Kidney problems

The doctor will carefully monitor the effects of Amifampridina Accord on you, and may adjust the
dose of the medicines you are taking. He/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 cancer, before starting treatment the doctor will perform
a careful assessment of the potential cancer risks associated with Amifampridina Accord
Inform all doctors you consult that you are using Amifampridina Accord.

Stop treatment and consult your doctor immediately if:

• Seizures (convulsions)
• Asthma

Other medicines and Amifampridina Accord
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can interact with Amifampridina Accord when taken together. The following
medicines must not be taken in combination with Amifampridina Accord:

• Medicines that can alter the electrical activity of the heart (QT interval prolongation, detectable with an electrocardiogram), for example, sultopride, disopyramide, cisapride, domperidone, rifampicin and ketoconazole (see “Do not take Amifampridina Accord”)

It is particularly important to inform your doctor if you are taking any of the following medicines or are
planning to start taking the following medicines:

• Antimalarials (for example, alofantrine 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 the treatment of Parkinson's disease - anticholinergics (for example, triesilfenidile, 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, succinylcholine)
• 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.
Amifampridina Accord must not be used during pregnancy. You should use effective
contraception during treatment. If the patient discovers she is pregnant during treatment,
she should inform her doctor immediately.
It is not known whether Amifampridina Accord is excreted in human breast milk. You should discuss
the risks and benefits of continuing therapy with Amifampridina Accord during
breastfeeding with your doctor.

Driving and using machines
This medicine can cause drowsiness, dizziness, seizures (convulsions) and blurred
vision, which can impair your ability to drive or operate machines. If you experience these
side effects, do not drive or operate machinery.

3. How to take Amifampridina Accord

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 to 5 mg (half a
tablet) four times a day (i.e., 20 mg per day). Subsequently, the doctor may continue to
increase the total daily dose by adding 5 mg (half a tablet) per 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). Total 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).

Patients with hepatic/renal pathologies:
Patients with renal or hepatic pathologies must use Amifampridina Accord with caution. For
patients with moderate or severe renal or liver problems, an initial daily dose of Amifampridina Accord of 5 mg (half a tablet) is recommended. Patients with mild renal or hepatic problems are recommended an initial daily dose of Amifampridina Accord of 10 mg (5
mg twice a day). In these patients, the dose of Amifampridina Accord must be increased
more slowly, with doses increasing by 5 mg every 7 days, compared to patients who do not complain
of renal or hepatic disorders. If adverse effects occur, consult your
doctor, as it may be necessary to stop increasing the dose.

Amifampridina Accord is for oral use.
The tablets have a score line that allows them to be broken in half.
The tablets must be swallowed with some water and must be taken with food.

If you take more Amifampridina Accord than you should
If you take more Amifampridina Accord 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 Amifampridina Accord
If you forget to take Amifampridina Accord, do not take a double dose to compensate for the
forgotten dose, but continue the treatment according to the doctor's prescriptions.

If you stop taking Amifampridina Accord
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 questions 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:

• Crisis (convulsions)
• Asthma

Very common side effects that can occur in more than 1 in 10 people are:

• Tingling and numbness around the mouth and extremities (such as hands and feet)
• Reduced sense of touch or reduced sensitivity
• Nausea
• Dizziness
• Increased sweating, cold sweat

Common side effects that can occur in 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 those who have had asthma episodes in the past
• Blurred vision
• Heart rhythm disturbances, fast or irregular heartbeat (palpitations)
• Weakness, fatigue, headache
• Anxiety, sleep disorders, drowsiness
• Chorea (movement disorder), myoclonus (muscle spasm or contraction)
• Increased levels of certain liver enzymes (transaminases) revealed by blood tests

Reporting of side effects
If you get any side effects, talk to your anesthesiologist or doctor. You can also report side effects directly through the Italian Medicines Agency Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Amifampridina Accord

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 package and on the blister after Expiry.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures help to protect the environment.

6. Contents of the pack and other information

What Amifampridina Accord 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 calcium stearate.

Description of the appearance of Amifampridina Accord and contents of the pack
Round tablet, of colour from white to off-white, with a flat face on one side
and with an incision on the other side. The tablets can be divided into equal doses.
Amifampridina Accord is available in packs of 100 or 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
HBM Pharma s.r.o.,
Sklabinska 30,
036 80 Martin,
Slovakia
Delorbis Pharmaceutical Ltd.,
17 Athinon street,
Ergates Industrial Area
2643 Ergates, Lefkosia
Cyprus

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany
Hungary
Italy
Netherlands
Norway
Portugal
Slovenia
Amifampridine Accord 10 mg tablets
Amifampridine Accord 10 mg tablets
Amifampridine Accord
Amifampridine Accord 10 mg tablets
Amifampridine Accord 10 mg tablets
Amifampridina Accord
Amifampridin Accord 10 mg tablets

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