Amifampridine Accord

Package leaflet: Information for the user

Amifampridina Accord 10 mg tablets

amifampridine
Please read this leaflet carefully before taking this medicine because 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 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

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

Amifampridina Accord is used in adults to treat the symptoms of a nerve and muscle disorder called Lambert-Eaton myasthenic syndrome (LEMS). This condition affects the transmission of nerve impulses to the muscles, causing muscle weakness. It may be associated with certain types of tumours (paraneoplastic form of LEMS) or occur in the absence of such tumours (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 nerve signals fully or partially.
Amifampridina Accord works by increasing the release of acetylcholine and thereby improving the transmission of nerve signals to the muscles.

2. What you need to know before taking Amifampridine Accord

Do not take Amifampridine Accord

• 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 (prolonged QT interval – detectable by electrocardiogram), such as:
  o Sulpiride (a medicine prescribed for the treatment of certain behavioural disorders in adults)
  o Antiarrhythmic medicines (e.g., disopyramide)
  o Medicines for the treatment of gastrointestinal problems (e.g., cisapride, domperidone)
  o Medicines for the treatment of infections – antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole)

• Together with medicines whose therapeutic dose is close to the maximum safe dose

• If you have congenital heart problems (congenital long QT syndrome)

If you are in doubt, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amifampridine Accord

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

Your doctor will carefully monitor the effects of Amifampridine Accord on you and may adjust the doses of any other medicines you are taking. Your doctor will also ask you to have a cardiological examination at the beginning of treatment and annually thereafter.
If you have LEMS but not cancer, your doctor will perform a careful assessment of the potential cancer risks associated with Amifampridine Accord before starting treatment.
Inform all your doctors that you are taking Amifampridine Accord.
Stop treatment and contact your doctor immediately if you experience:

• Seizures (convulsions)
• Asthma

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

• Medicines that may alter the electrical activity of the heart (prolonged QT interval, detectable by electrocardiogram), for example, sulpiride, disopyramide, cisapride, domperidone, rifampicin and ketoconazole (see "Do not take Amifampridine Accord")

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

• Antimalarials (e.g., halofantrine, mefloquine)
• Tramadol (a painkiller)
• Antidepressants – tricyclic antidepressants (e.g., clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g., citalopram, dapoxetine), and atypical antidepressants (e.g., bupropion)
• Medicines for mental disorders (e.g., haloperidol, carbamazepine, chlorpromazine, clozapine)
• Medicines for Parkinson’s disease – anticholinergics (e.g., trihexyphenidyl, mesylate), MAO-B inhibitors (e.g., selegiline, deprenyl), COMT inhibitors (e.g., entacapone)
• Medicines for allergies – antihistamines (e.g., terfenadine, astemizole, cimetidine)
• Muscle relaxants (e.g., mivacurium, pipecuronium, succinylcholine)
• Sedatives (e.g., barbiturates)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Amifampridine Accord must not be used during pregnancy. You must use an effective method of contraception during treatment. If you become pregnant while taking this medicine, inform your doctor immediately.
It is not known whether Amifampridine Accord is excreted in human breast milk. You should discuss with your doctor the risks and benefits of continuing Amifampridine Accord treatment while breastfeeding.

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

3. How to take Amifampridine Accord

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Your dose will be determined by your doctor based on the severity of your symptoms and certain genetic factors. This dose is intended specifically for you.
The recommended starting dose is 5 mg of amifampridine (half a tablet) three times a day (i.e., 15 mg daily). Your doctor may gradually increase this dose to 5 mg (half a tablet) four times a day (i.e., 20 mg daily). Afterwards, your 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 taken at intervals throughout the day). Total daily doses exceeding 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 disorders:
Patients with renal or hepatic disorders should use Amifampridine Accord with caution. For patients with moderate or severe renal or hepatic impairment, a recommended starting daily dose of Amifampridine Accord is 5 mg (half a tablet). For patients with mild renal or hepatic impairment, a recommended starting daily dose of Amifampridine Accord is 10 mg (5 mg twice daily). In these patients, the dose of Amifampridine Accord should be increased more slowly, with dose increments of 5 mg every 7 days, compared to patients without renal or hepatic disorders. If any adverse effects occur, consult your doctor, as it may be necessary to stop increasing the dose.

Amifampridine Accord is for oral use.
The tablets have a score line allowing them to be divided into equal halves.
The tablets should be swallowed with some water and must be taken with food.

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

If you forget to take Amifampridine Accord
If you forget to take Amifampridine Accord, do not take a double dose to make up for the missed dose. Continue your treatment as prescribed by your doctor.

If you stop taking Amifampridine Accord
If you stop treatment, you may experience symptoms such as fatigue, slowed reflexes, and constipation. Do not stop treatment without consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment and consult your doctor immediately if you experience:

• Seizures
• Asthma

Very common side effects (may affect more than 1 in 10 people):

• 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 sweats

Common side effects (may affect up to 1 in 10 people):

• Stomach discomfort
• Cold hands and feet

Other side effects:

• The intensity and incidence of most side effects depend on the dose you are taking.
• The following side effects have been reported, among others (frequency cannot be estimated from the available data):
• Raynaud's syndrome (a circulatory disorder affecting fingers of hands and feet)
• Diarrhea
• Seizures
• Cough, excessive or sticky mucus in the airways, asthma attacks in patients with asthma or in those who have had episodes of asthma in the past
• Blurred vision
• Heart rhythm disorders, rapid or irregular heartbeat (palpitations)
• Weakness, fatigue, headache
• Anxiety, sleep disturbances, drowsiness
• Chorea (motor disorder), myoclonus (muscle spasm or contraction)
• Increase in certain liver enzymes (transaminases), detected by blood tests

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your anaesthetist or doctor.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects 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 carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures help protect the environment.

6. Pack contents and other information

What Amifampridine Accord contains
The active substance is amifampridine. Each tablet contains amifampridine phosphate equivalent to
10 mg of amifampridine.
The other components are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
Description of the appearance of Amifampridine Accord and pack sizes
Round tablet, white to off-white in colour, with a flat surface on one side
and a score line on the other side. The tablets can be divided into equal doses.
Amifampridine Accord is available in packs of 100 or 100 x 1 tablets.
Not all pack sizes may be marketed.
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 European Economic Area countries with the
following names:
Germany Amifampridine Accord 10 mg tablets
Hungary Amifampridine Accord 10 mg tablets
Italy Amifampridine Accord
Netherlands Amifampridine Accord 10 mg tablets
Norway Amifampridine Accord 10 mg tablets
Portugal Amifampridina Accord
Slovenia Amifampridin Accord 10 mg tablets
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