Инструкция по применению GALAFOLD
Содержание инструкции
Galafold 123 mg hard capsules
migalastat
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, pharmacist or nurse.
- 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, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Galafold is and what it is used for
- 2. What you need to know before you take Galafold
- 3. How to take Galafold
- 4. Possible side effects
- 5. How to store Galafold
- 6. Contents of the pack and other information
1. What is Galafold and what is it used for
Galafold contains the active substance migalastat.
This medicine is used for the long-term treatment of Fabry disease in adults and adolescents aged 12 years and over with certain genetic mutations (variations).
Fabry disease is caused by a deficiency or incorrect functioning of an enzyme called alpha-galactosidase A (α-Gal A). Depending on the type of mutation (variation) in the gene that produces α-Gal A,
the enzyme does not function correctly or is completely absent. This enzymatic defect causes abnormal deposits of a fatty substance called globotriaosylceramide (GL-3) in the kidneys, heart and other organs,
causing the symptoms of Fabry disease.
This medicine works by stabilizing the enzyme that the body produces naturally, so that it can
function better to reduce the amount of GL-3 that has accumulated in cells and tissues.
2. What you need to know before you take Galafold
Do not take Galafold
- if you are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Migalastat 123 mg capsules are not suitable for children (≥12 years) with a body weight of less than 45 kg.
Talk to your doctor before taking Galafold if you are receiving enzyme replacement therapy.
You must not take Galafold if you are also receiving enzyme replacement therapy.
The doctor will monitor your condition and check if the medicine is working every 6 months during therapy
with Galafold. If your condition worsens, the doctor may carry out further investigations or stop therapy with
Galafold.
Talk to your doctor before taking Galafold if you have severely reduced kidney function, as
Galafold is not recommended for use in patients with severe renal impairment (GFR less than 30
mL/min/1.73m²)
Children
Children <12 years
Because the medicine has not been studied in children under 12 years of age, safety and efficacy in
this age group have not been established.
Other medicines and Galafold
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This includes medicines you get without a prescription, including supplements
and herbal remedies.
In particular, tell your doctor if you are taking medicines or supplements containing caffeine, as these
medicines, if taken during the fasting period, may affect the functioning of Galafold.
You should know the medicines you are taking. Keep a list of them and show it to your doctor and pharmacist
every time you take a new medicine.
Pregnancy, breastfeeding and fertility
Pregnancy
Experience with the use of this medicine in pregnant women is limited. Galafold is not
recommended during pregnancy. If you are pregnant or suspect you may be pregnant or are planning a
pregnancy, ask your doctor for advice before taking this medicine.
Women of childbearing potential must use effective contraception during therapy with Galafold.
Breastfeeding
If you are breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. It is not yet known whether the medicine passes into breast milk. The doctor will decide if
it is necessary to stop breastfeeding or temporarily suspend therapy, considering the benefits of breastfeeding
for the baby and the benefits of Galafold for the mother.
Fertility in men
It is not yet known whether this medicine affects the fertility of men. The effects of Galafold on fertility
in men have not been studied.
Fertility in women
It is not yet known whether this medicine affects the fertility of women.
If you are planning a pregnancy, ask your doctor, pharmacist or nurse for advice.
Driving and operating machinery
This medicine is not expected to affect your ability to drive and operate machinery.
3. How to take Galafold
Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Take one capsule on alternate days at the same time. Do not take Galafold for two consecutive days.
Do not consume food or caffeine for at least 2 hours before and 2 hours after taking the medicine. This
period of at least 4 hours of fasting for taking the medicine is necessary for the medicine to be
completely absorbed.
During the 4 hours of fasting, you can consume water (plain, flavored, sweetened), fruit juices
without pulp and caffeine-free carbonated drinks.
Swallow the capsules whole. Do not divide, crush or chew the capsule.
Figure A n a i![]() | l e d 1: Remove the adhesive seal that keeps the cardboard box closed. a Open the cardboard box of Galafold (see figure A). |
l Figure B - Open box a t I a i z n![]() | 2: Press and hold the purple tab on the left side of the box (see figure B) and proceed to step 3. |
Figure C![]() | o c 3: Now GRASP the tab on the right side where it says “PULL HERE” and remove the a folded blister (see figure C). m | |
Figure D - Front of the blister![]() | r a F 4: Open the blister (see figure D). l | |
e Taking Galafold capsules: One blister of Galafold = 14 hard capsules = 28 days of treatment with Galafold and 14 white circles. d The white circles are to remind you to take Galafold on alternate days. The arrow indicates to the patient the start of the next 2 weeks of treatment. a Figure E - Front of the blister n a i l a![]() | ||
t Figure F - Front of the blister I a i z n e![]() | 5: On the first day you take the medicine from a new blister, record the date on the blister itself (see figure F). | |
Figure G - Back of the blister![]() | o 6: TURN the blister over to the back. c LOCATE the capsule to remove. a BEND the blister as shown (see figure G). m Note: Bending the blister helps to lift the perforated oval r a |
Figure H - Back of the blister a![]() | F l e 7: REMOVE the perforated oval (see figure H) a Note: After removing the oval, the white back of the aluminum foil may remain, but this is not a problem.![]() |
i Figure I - Front of the blister l a t I a i z n![]() | 8: TURN the blister over to the front. PRESS the capsule to make it come out (see figure I). |
Figure J - Front of the blister![]() | 9: The next day, move to the white circle perforated on the top row with the writing o day 2. Press the white circle to remove it (see c figure J). a Note: Removing the white circle will help you m remember on which day you did not take the medicine. r Take 1 Galafold capsule only on alternate days. a Close the package and store it after each use. |
After day 2, move to day 3 on the blister. Alternate days taking the capsule and punching the perforated white circles, up to and including day 28. e Figure K - Unfolded blister front d a n a i l a![]() | |
If you take more Galafold than you should
If you take more capsules than you should, you should stop taking the medicine and contact your doctor.
You may experience headache and dizziness.
If you forget to take Galafold
If you forget to take the capsule at the usual time but remember it later during the same day,
you can take the capsule only if no more than 12 hours have passed since the normal time for taking the
dose. If more than 12 hours have passed, you should resume taking Galafold on the next day and at the usual time,
according to the alternate-day dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop taking Galafold
Treatment should not be interrupted without consulting your doctor.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Very common: may affect more than 1 in 10 people
- Headache
Common: may affect up to 1 in 10 people
- Palpitations (feeling of a fast-beating heart)
- Feeling dizzy (vertigo)
- Diarrhoea
- Feeling sick (nausea)
- Stomach pain
- Constipation
- Dry mouth
- Urgent need to defecate
- Indigestion (dyspepsia)
- Fatigue
- Reduced tactile or sensory sensitivity (hypoesthesia)
- Depression
- Protein in urine (proteinuria)
- Shortness of breath (dyspnea)
- Nosebleed (epistaxis)
- Rash
- Persistent itching
- Pain
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Galafold
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 Exp. The
expiry date refers to the last day of that month.
This medicine does not require special temperature storage conditions. Store in the
original package to protect the medicine from moisture.
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 Galafold contains
- The active substance is migalastat. Each capsule contains migalastat hydrochloride equivalent to 123 mg of migalastat.
- The other ingredients are: Capsule content: pregelatinized starch (corn) and magnesium stearate
- Increased creatine phosphokinase in blood tests
- Weight gain
- Muscle spasms
- Muscle pain (myalgia)
- Painful stiff neck (nuchal rigidity)
- Tingling of extremities (paresthesia)
- Dizziness
Capsule shell: gelatin, titanium dioxide (E171) and indigotine, indigo carmine (E132)
Printing ink: shellac, black iron oxide and potassium hydroxide
Description of Galafold and contents of the pack
White, blue and opaque hard capsules, bearing the inscription “A1001” in black ink, hard capsules of
size 2 (6.4x18.0 mm) containing powder from white to light brown.
Galafold is available in blister packs containing 14 capsules.
Marketing Authorisation Holder
Amicus Therapeutics Europe Limited
Block 1, Blanchardstown Corporate Park
Ballycoolin Road
Blanchardstown, Dublin
D15 AKK1
Ireland
Tel: +353 (0) 1 588 0836
Fax: +353 (0) 1 588 6851
e-mail: [email protected]
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk, Co. Louth
A91 P9KD
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder (if you cannot contact the Amicus representative by telephone, please contact them by e-mail at the address below):
België/Belgique/Belgien
AmicusTherapeutics Europe Limited
Tél/Tel: (+32) 0800 89172
e-mail: [email protected]
Lietuva
Amicus Therapeutics Europe Limited
Tel: (+370) 8800 33167
El. paštas: [email protected]
България
Amicus Therapeutics Europe Limited
Teл.: (+359)00800 111 3214
имейл: [email protected]
Luxembourg/Luxemburg
AmicusTherapeutics Europe Limited
Tél/Tel: (+352) 800 27003
e-mail: [email protected]
Českárepublika
Amicus Therapeutics Europe Limited
Tel.: (+420) 800 142 207
e-mail: [email protected]
Magyarország
Amicus Therapeutics Europe Limited
Tel.: (+36) 06 800 21202
e-mail: [email protected]
Danmark
Amicus Therapeutics Europe Limited
Tlf.: (+45) 80 253 262
e-mail: [email protected]
Malta
Amicus Therapeutics Europe Limited
Tel: (+356) 800 62674
e-mail: [email protected]
Deutschland
AmicusTherapeutics GmbH
Tel: (+49) 0800 000 2038
E-Mail: [email protected]
Nederland
Amicus Therapeutics BV
Tel: (+31) 0800 022 8399
e-mail: [email protected]
Eesti
Amicus Therapeutics Europe Limited
Tel: (+372) 800 0111 911
e-post: [email protected]
Norge
Amicus Therapeutics Europe Limited
Tlf: (+47) 800 13837
e-post: [email protected]
Ελλάδα
AmicusTherapeutics Europe Limited
Τηλ: (+30) 00800 126 169
e-mail: [email protected]
Österreich
Amicus Therapeutics Europe Limited
Tel: (+43) 0800 909 639
E-Mail: [email protected]
España
Amicus Therapeutics S.L.U.
Tel: (+34) 900 941 616
e-mail: [email protected]
Polska
Amicus Therapeutics Europe Limited
Tel.: (+48) 0080 012 15475
e-mail: [email protected]
France
AmicusTherapeutics SAS
Tél: (+33) 0 800 906 788
e-mail: [email protected]
Portugal
AmicusTherapeutics Europe Limited
Tel: (+351) 800 812 531
e-mail: [email protected]
Hrvatska
AmicusTherapeutics Europe Limited
Tel: (+385) 0800 222 452
e-pošta: [email protected]
Ireland
AmicusTherapeutics Europe Limited
Tel: (+353) 1800 936 230
e-mail: [email protected]
România
AmicusTherapeutics Europe Limited
Tel.: (+40) 0808 034 288
e-mail: [email protected]
Slovenija
AmicusTherapeutics Europe Limited
Tel: (+386) 0800 81794
e-pošta: [email protected]
Ísland
Amicus Therapeutics Europe Limited
Sími: (+354) 800 7634
Netfang: [email protected]
Slovenskárepublika
Amicus Therapeutics Europe Limited
Tel.: (+421) 0800 002 437
e-mail: [email protected]
Italia
Amicus Therapeutics S.r.l.
Tel: (+39) 800 795 572
e-mail: [email protected]
Suomi/Finland
AmicusTherapeutics Europe Limited
Puh/Tel: (+421) 0800 917 780
sähköposti/e-mail: [email protected]
Κύπρος
AmicusTherapeutics Europe Limited
Τηλ: (+357) 800 97595
e-mail: [email protected]
Sverige
Amicus Therapeutics Europe Limited
Tfn: (+46) 020 795 493
e-post: [email protected]
Latvija
Amicus Therapeutics Europe Limited
Tel: (+371) 800 05391
e-pasts: [email protected]
United Kingdom (Northern Ireland)
Amicus Therapeutics, UK Limited
Tel: (+44) 08 0823 46864
e-mail: [email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Also, links to other websites on rare diseases and related therapeutic
treatments are provided.

- Страна регистрации
- Форма выпускаHard capsule, 123 MG
- Код АТХA16AX14
- 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 GALAFOLDФорма выпуска: Tablet, 500 MGДействующее вещество: Фенилбутират натрияПроизводитель: IMMEDICA PHARMA ABОтпускается без рецептаФорма выпуска: Hard capsule, 84 MGДействующее вещество: ЭлиглюстатПроизводитель: SANOFI B.V.Отпускается по рецептуФорма выпуска: Hard capsule, 200 MGДействующее вещество: trientineПроизводитель: UNIVAR SOLUTION BVОтпускается по рецепту
Аналоги GALAFOLD в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог GALAFOLD в Испания
Аналог GALAFOLD в Украина
Врачи онлайн по GALAFOLD
Обсудите применение GALAFOLD и возможные следующие шаги — по оценке врача.
Получите рецепт на GALAFOLD онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
GALAFOLD требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество GALAFOLD — migalastat. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
GALAFOLD производится компанией AMICUS THERAPEUTICS EUROPE LIMITED. 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 GALAFOLD 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 GALAFOLD 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 (migalastat) включают AMMONAPS, KERDELGA, KUFENKE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.




























