Amifampridine Serb

B: PACKAGE LEAFLET

Package leaflet: information for the user

Amifampridina SERB 10 mg tablets

amifampridine
Please 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amifampridina SERB contains the active substance amifampridina.
Amifampridina SERB 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 affected by this disorder, a chemical called acetylcholine, which transmits nerve impulses to the muscles, is not released normally, and the muscle does not receive nerve signals fully or at all.
Amifampridina SERB works by increasing the release of acetylcholine, thereby improving the transmission of nerve signals to the muscles.

2. What you need to know before taking Amifampridine SERB

Do not take Amifampridine SERB
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:
sultopride (a medicine prescribed for the treatment of certain behavioural disorders in adults),
antiarrhythmic medicines (e.g., disopyramide),
medicines for the treatment of gastrointestinal problems (e.g., cisapride, domperidone),
medicines for the treatment of infections – antibiotics (e.g., 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 long QT syndrome).
If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amifampridine SERB.
Inform your doctor if you have:
asthma,
a history of seizures (convulsions),
kidney problems,
liver problems.

Your doctor will carefully monitor the effects of Amifampridine SERB on you and may adjust the dosage of your other medicines. Your doctor will also ask you to undergo a cardiological examination at the beginning of treatment and annually thereafter.

If you have LEMS but not cancer, your doctor will perform a thorough assessment of the potential cancer risks associated with Amifampridine SERB before starting treatment.
Inform all doctors treating you that you are taking Amifampridine SERB.

Stop treatment and contact your doctor immediately if you experience:
seizures (convulsions),
asthma.

Other medicines and Amifampridine SERB
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Amifampridine SERB when taken together. The following medicines must not be taken in combination with Amifampridine SERB:
medicines that may alter the electrical activity of the heart (prolonged QT interval, detectable by electrocardiogram), for example, sultopride, disopyramide, cisapride, domperidone, rifampicin and ketoconazole (see "Do not take Amifampridine SERB").

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, suxamethonium),
sedatives (e.g., barbiturates).

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

Driving and using machines
This medicine may cause drowsiness, dizziness, seizures (convulsions), and blurred vision, and may therefore impair your ability to drive or operate machinery. Do not drive or operate machinery if you experience any of these side effects.

3. How to take Amifampridine SERB

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The dose to be taken will be determined by your doctor based on the severity of symptoms and certain genetic factors. This dose is intended specifically for you.
The recommended starting dose is 5 mg of amifampridine (half a tablet), taken three times a day (i.e. 15 mg per day). Your doctor may gradually increase this dose to 5 mg (half a tablet) four times a day (i.e. 20 mg per day). 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 times daily). The single dose must never exceed 20 mg (two tablets).
The tablets have a score line which allows them to be divided into two equal parts. The tablets must be swallowed with some water and taken together with food.

Patients with kidney or liver disease:
Patients with kidney or liver disease should use Amifampridine SERB with caution. For patients with moderate or severe kidney or liver problems, a recommended starting daily dose of Amifampridine SERB is 5 mg (half a tablet). For patients with mild kidney or liver problems, a recommended starting daily dose of Amifampridine SERB is 10 mg (5 mg twice daily). In these patients, the dose of Amifampridine SERB should be increased more slowly, with doses increased by 5 mg every 7 days, compared to patients without kidney or liver disorders. If any adverse effects occur, you should consult your doctor, as it may be necessary to stop increasing the dose.

If you take more Amifampridine SERB than you should
If you take more Amifampridine SERB than prescribed, you may experience vomiting or stomach discomfort. If you notice any of these symptoms, contact your doctor or pharmacist immediately.

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

If you stop taking Amifampridine SERB
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 everybody gets them.
Stop taking the medicine and consult your doctor immediately if you experience:
Seizures (convulsions)
Asthma

Very common side effects (may affect more than 1 in 10 people):
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 (may affect up to 1 in 10 people):
Stomach ache
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 (frequency cannot be determined from the available data):
Raynaud's syndrome (a circulatory disorder affecting fingers of the hands and feet)
Diarrhoea
Seizures (convulsions)
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, 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), detected by blood tests

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amifampridine SERB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging, to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amifampridine SERB contains
The active substance is amifampridine. Each tablet contains amifampridine phosphate equivalent
to 10 mg of amifampridine.
The other components are microcrystalline cellulose, colloidal anhydrous silica, and calcium stearate.

Description of the appearance of Amifampridine SERB and package contents
White, round, flat tablet, with one side plain and a dividing line on the other side.
The tablet can be divided into two equal doses.
10 x 1 tablets in perforated single-dose aluminum-PVC/PVDC blisters.
Pack sizes of 90 x 1 tablets, 100 x 1 tablets, and 120 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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

Amifampridine SERB contains the same active substance and acts in the same way as the reference medicine already authorised in the EU. The reference medicine has been granted a marketing authorisation under "exceptional circumstances". This means that, due to the rarity of the disease, it has not been possible to obtain complete information on the reference medicine.
The European Medicines Agency will review annually any new information on the reference medicine, and the Amifampridine SERB package leaflet will be updated, if necessary.
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.