Інструкція із застосування FAMPRIDINA AKKORD
Зміст інструкції
Fampridina Accord 10 mg prolonged-release tablets
fampridina
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 their symptoms are the same as yours, 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 Fampridina Accord is and what it is used for
- 2. What you need to know before you take Fampridina Accord
- 3. How to take Fampridina Accord
- 4. Possible side effects
- 5. How to store Fampridina Accord
- 6. Contents of the pack and other information
1. What is Fampridina Accord and what is it used for
Fampridina Accord contains the active substance fampridine, which belongs to the class of drugs
defined as potassium channel blockers. These medicines work by blocking the loss of potassium
that occurs in nerve cells damaged by multiple sclerosis (MS). It is believed that this
drug works by facilitating the normal passage of signals along the nerve and consequently improving
the patient's walking ability.
Fampridina Accord is a medicine used to improve walking in adults (aged
18 years and over) with walking disability related to Multiple Sclerosis (MS).
In multiple sclerosis, inflammation destroys the protective sheath around the nerves, leading to
muscle weakness, muscle stiffness and difficulty walking.
2. What you need to know before taking Fampridina Accord
Do not take Fampridina Accord
- if you are allergicto fampridine or any of the other ingredients of this medicine (listed in section 6)
- if you have or have everhad a seizure(also called a convulsive crisis or convulsion)
- if your doctor or nurse has told you that you have moderate or severe kidney problems
- if you are taking a medicine called cimetidine
- if you are taking other medicines containing fampridine. In this case, the risk of serious side effects may increase
If you recognize yourself in any of the above conditions, tell your doctorand do not take
Fampridina Accord.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fampridina Accord:
- if you feel your heartbeat (palpitations)
- if you are particularly susceptible to infections
- if you have any factors predisposing to seizures or are taking any medicine that affects the risk of seizures (seizure)
- if a doctor has told you that you have mild kidney problems.
- if you have a history of allergic reactions. You may need to use a support for walking (e.g., a cane) as needed because this medicine may cause dizziness or instability, therefore it can lead to an increased risk of falls.
If you recognize yourself in any of the above conditions, tell your doctorbefore taking
Fampridina Accord.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Elderly
Before starting treatment and during therapy, your doctor may check your kidney function.
Other medicines and Fampridina Accord
Tell your doctor or pharmacistif you are taking, have recently taken, or might take
any other medicines.
Do not take Fampridina Accord if you are taking any other medicine containing
fampridine.
Medicines that affect the kidneys
Your doctor will proceed with particular caution if fampridine is taken at the same time as
medicines that may affect how the kidneys eliminate medicines, such as
carvedilol, propanolol and metformin.
Pregnancy and breastfeeding
If you are pregnant,if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctorfor advice before taking Fampridina Accord.
Fampridina Accord is not recommended during pregnancy.
The doctor will assess the benefit-risk ratio of treatment with Fampridina Accord for the child.
Do not breastfeedwith breast milk during treatment with this medicine.
Driving and using machines
Fampridina Accord may affect your ability to drive vehicles or use machinery. The medicine
can in fact cause dizziness. Before driving vehicles or using machinery, make sure
you do not experience these effects.
3. How to take Fampridina Accord
Take this medicine following exactly the instructions of your doctor. If you have any doubts consult your
doctor or pharmacist. Fampridina Accord is only available with a prescription and under the
supervision of doctors experienced in the treatment of multiple sclerosis.
Your doctor will give you an initial prescription for a period of 2 to 4 weeks. The treatment will be
re-evaluated after 2-4 weeks.
The recommended dose is
Onetablet in the morning and onetablet in the evening (12 hours apart). Do not take more than two
tablets a day. Allow 12 hoursbetween one tablet and the next. Do not take the next tablet before 12 hours have passed since the previous one.
Fampiridina Accord is a medicine for oral use.
Swallow the tablet wholewith a glass of water. The tablet must not be broken,
powdered, dissolved, sucked or chewed, as this could increase the risk of undesirable effects.
This medicine must be taken without food, on an empty stomach.
If you take more Fampridina Accord than you should
If you take too many tablets, seek immediate medical advice.
When you go to the doctor, take the Fampridina Accord packaging with you.
In case of overdose, symptoms such as sweating, minor trembling
( tremor), dizziness, confusion, memory loss ( amnesia) and convulsions ( seizures) may occur. It is
also possible that undesirable effects not listed in this leaflet may occur.
If you forget to take Fampridina Accord
If you forget to take a tablet, do not take a double dose to make up for the
missed tablet. You must always allow 12 hoursbetween one tablet and the next.
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.
If you should experience seizures, stop taking Fampridina Accordand inform
your doctor immediately.
If you experience one or more of the following allergic symptoms ( hypersensitivity): swelling of the face, mouth, lips, throat or tongue, redness or itching of the skin, chest tightness and breathing problems, stop taking Fampridina Accordand seekimmediate medical attention.
Side effects are listed below in order of frequency.
Very common side effects
May affect more than 1 in 10 people:
- urinary tract infection
Common side effects
May affect up to 1 in 10 people:
- feeling unsteady
- dizziness
- feeling faint ( vertigo)
- headache
- feeling tired or weak
- difficulty sleeping
- anxiety
- minor tremor ( tremor)
- feeling of numbness or tingling in the skin
- sore throat
- common cold ( nasopharyngitis)
- influenza
- Viral infection
- difficulty breathing ( shortness of breath)
- Feeling unwell (nausea)
- vomiting
- constipation
- stomach discomfort
- back pain
- perception of your heartbeat (palpitations)
Uncommon side effects
May affect up to 1 in 100 people:
- seizures ( epileptic fit)
- allergic reaction ( hypersensitivity)
- Severe allergy ( anaphylactic reaction)
- Swelling of the face, lips, mouth or tongue ( angioedema)
- Onset or Worsening of facial neuropathic pain ( trigeminal neuralgia)
- fast heart rate (tachycardia)
- Dizziness or loss of consciousness ( hypotension)
- Skin rash/itchy rash ( urticaria)
- Chest discomfort
Reporting of side effects
If you get any side effects, talk to 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 provide more information on the safety of this medicine.
5. How to store Fampridina 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 pack after Exp.. The expiry
date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 Fampridina Accord contains
- The active ingredientis fampridine.
- Each prolonged-release tablet contains 10 mg of fampridine.
- Other ingredientsare:
- tablet core: hypromellose (E464), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), magnesium stearate (E572);
- film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521)
Description of the appearance ofFampridina Accord and contents of the pack
White to off-white, oval-shaped, biconvex tablets approximately 13.1 x 8.1 mm, film-coated with
a bevelled edge and the inscription “FH6” on one side and smooth on the other side.
Fampridina Accord 10 mg prolonged-release tablets are packaged in perforated unit-dose blisters containing 28 x 1, 49 x1, 56 x 1 or 196 x 1 tablets (consisting of 4 packs, each
containing 49 × 1 tablets).
Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6a Planta,
Barcelona, 08039
Spain
Manufacturer
Accord Healthcare Polska Sp.z.o.o.
Ul. Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000, Malta
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain
Accord Healthcare single member S.A. 64th Km
National Road Athens, Lamia,
Schimatari, 32009,
Greece
For further information on this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:
BE / BG / CZ / DK / DE / EE / IE / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL / AT /
PL / PT / RO / SI / SK / FI / SE
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .
- Країна реєстрації
- Лікарська формаExtended-release tablet, 10 MG
- Код АТХN07XX07
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FAMPRIDINA AKKORDЛікарська форма: Extended-release tablet, 10 MGДіюча речовина: ФампридинВиробник: MERZ THERAPEUTICS GMBHПотрібен рецептЛікарська форма: Tablet, 10 mgДіюча речовина: amifampridineВиробник: ACCORD HEALTHCARE, S.L.U.Потрібен рецептЛікарська форма: Tablet, 10 mgДіюча речовина: amifampridineВиробник: SERB S.A.Потрібен рецепт
Аналоги FAMPRIDINA AKKORD в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FAMPRIDINA AKKORD у Іспанія
Аналог FAMPRIDINA AKKORD у Польща
Аналог FAMPRIDINA AKKORD у Україна
Лікарі онлайн щодо FAMPRIDINA AKKORD
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FAMPRIDINA AKKORD онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
FAMPRIDINA AKKORD потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FAMPRIDINA AKKORD — Фампридин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FAMPRIDINA AKKORD виробляється компанією ACCORD HEALTHCARE, S.L.U.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FAMPRIDINA AKKORD з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FAMPRIDINA AKKORD у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Фампридин) включають FAMPYRA, AMIFAMPRIDINA AKKORD, AMIFAMPRIDINA SERB. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















