Инструкция по применению AMIFAMPRIDINA SERB
Содержание инструкции
Amifampridina SERB 10 mg tablets
amifampridina
Read this leaflet carefully before you start 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 could 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 SERB is and what it is used for
- 2. What you need to know before you take 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 is Amifampridina SERB and what is it used for
Amifampridina SERB contains the active substance amifampridine.
Amifampridina SERB 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 SERB 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 SERB
Do not take Amifampridina SERB
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 (Prolonged QT interval –
detectable with an electrocardiogram), such as:
sultopride (a medicine prescribed for the treatment of certain behavioral disorders in adults),
an antiarrhythmic medicine (e.g., disopyramide)
medicines for the treatment of digestive 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 safety 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 Amifampridina SERB.
Tell your doctor if you have
Asthma
A history of seizures (convulsions)
Kidney problems
Liver problems
The doctor will carefully monitor the effects of Amifampridina SERB on you, and may adjust the
dose of the medicines you are taking. He will also ask you to have a cardiology examination
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 risks of cancer associated with Amifampridina SERB.
Tell all doctors you see that you are using Amifampridina SERB.
Stop treatment and consult your doctor immediately if:
Seizures (convulsions)
Asthma
Other medicines and Amifampridina SERB
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can interact with Amifampridina SERB when taken together. The following
medicines should not be taken in combination with Amifampridina SERB:
Medicines that can alter the electrical activity of the heart (prolonged QT interval, detectable
with an electrocardiogram), for example, sultopride, disopyramide, cisapride, domperidone, rifampicin
and ketoconazole (see “Do not take Amifampridina SERB”).
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 (e.g., alofantrine and 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 the treatment of Parkinson's disease - anticholinergics (e.g., triesilfenidile,
mesylate), MAO-B inhibitors (e.g., selegiline, deprenyl), COMT inhibitors (e.g.,
entacapone)
Medicine for the treatment of allergies - antihistamines (e.g., terfenadine, astemizole,
cimetidine)
Medicines for muscle relaxation - (e.g., mivacurium, pipercurium, succinylcholine)
Sedatives (e.g., barbiturates)
Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 SERB should 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 SERB is excreted in human breast milk. You should discuss the
risks and benefits of continuing therapy with Amifampridina SERB during
breastfeeding with your doctor.
Driving and operating machinery
This medicine can cause drowsiness, dizziness, seizures (convulsions) and blurred vision and can
therefore impair the ability to drive vehicles or operate machinery. Do not drive and do not operate machinery if you
experience these side effects.
3. How to take Amifampridina SERB
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 amifampridina (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).
The tablets have a score line that allows them to be divided in half. The tablets must
be swallowed with a little water and also ingesting some food.
Patients with kidney and liver diseases:
Patients with kidney and liver diseases must use Amifampridina SERB with caution. For
patients with moderate or severe kidney or liver problems, an initial daily dose of Amifampridina SERB of 5 mg (half a tablet) is recommended. Patients with mild kidney or liver problems are recommended an initial daily dose of Amifampridina SERB of 10 mg (5 mg
twice a day). In these patients, the dose of Amifampridina SERB should be increased more
slowly, with doses increasing by 5 mg every 7 days, compared to patients who do not complain
of kidney or liver disorders. If adverse effects occur, consult your
doctor, as it may be necessary to stop increasing the dose.
If you take more Amifampridina SERB than you should
If you take more Amifampridina SERB 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 SERB
If you forget to take Amifampridina SERB, do not take a double dose to make up for the missed dose,
but continue treatment as prescribed by your doctor.
If you stop taking Amifampridina SERB
If you stop treatment, you may experience symptoms such as fatigue, slow reflexes and constipation. Do not
stop treatment without consulting your doctor.
If you have any further questions on 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:
Seizures (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 decreased 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 depend 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
Seizures (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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.
5. How to store Amifampridina SERB
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging, to protect the medicine from light.
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 Amifampridina SERB 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 SERB 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 doses.
10 x 1 tablet in perforated single-dose aluminum-PVC/PVDC blisters.
Packs of 90 x 1 tablet, 100 x 1 tablet and 120 x 1 tablet.
Not all pack sizes may be marketed.
Marketing authorization 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
Amifampridina SERB contains the same active ingredient and works in the same way as the reference medicine
already authorized in the EU. The reference medicine was granted an authorization in
“exceptional circumstances”. This means that due to the rarity of the disease it was not possible to obtain
complete information on the reference medicine.
The European Medicines Agency will review any new information on
necessary annually.
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
- Страна регистрации
- Форма выпускаTablet, 10 mg
- Код АТХN07XX05
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги AMIFAMPRIDINA SERBФорма выпуска: Tablet, 10 mgДействующее вещество: amifampridineПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецептуФорма выпуска: Tablet, 10 MGДействующее вещество: amifampridineПроизводитель: SERB S.A.Отпускается по рецептуФорма выпуска: Injectable solution in pre-filled syringe, 25 mgДействующее вещество: ВутрисиранПроизводитель: ALNYLAM NETHERLANDS BVОтпускается по рецепту
Аналоги AMIFAMPRIDINA SERB в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог AMIFAMPRIDINA SERB в Испания
Аналог AMIFAMPRIDINA SERB в Украина
Врачи онлайн по AMIFAMPRIDINA SERB
Обсудите применение AMIFAMPRIDINA SERB и возможные следующие шаги — по оценке врача.
Получите рецепт на AMIFAMPRIDINA SERB онлайн
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
AMIFAMPRIDINA SERB требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество AMIFAMPRIDINA SERB — amifampridine. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
AMIFAMPRIDINA SERB производится компанией SERB S.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения AMIFAMPRIDINA SERB с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить AMIFAMPRIDINA SERB в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (amifampridine) включают AMIFAMPRIDINA AKKORD, FIRDAPSE, AMVUTTRA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















