GALAFOLD 123 mg HARD CAPSULES

Ask a doctor about a prescription for GALAFOLD 123 mg HARD CAPSULES

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Abdullah Alhasan

General medicine10 years of experience

Dr. Abdullah Alhasan is a physician specialising in cardiology and general medicine, with international clinical experience and a commitment to evidence-based care. He offers online consultations for adults, focusing on both acute symptoms and long-term health management.

Main areas of consultation:

Chest pain, shortness of breath, heart palpitations, high blood pressure
Hypertension control and cardiovascular disease prevention
Interpretation of ECG, blood tests, and Holter monitor results
Management of heart failure and coronary artery disease
General medical issues: infections, fever, fatigue, gastrointestinal symptoms
Guidance on diagnostics, treatment plans, and medication adjustments

Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.

Book a video appointment

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

12+ years of clinical experience in university hospitals in Germany and Spain.
International education: Ukraine – Germany – Spain.
Member of the German Society of Surgeons (BDC).
Certified in radiological diagnostics and robotic surgery.
Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

Book a video appointment

Abdullah Alhasan

General medicine10 years of experience

Main areas of consultation:

Chest pain, shortness of breath, heart palpitations, high blood pressure
Hypertension control and cardiovascular disease prevention
Interpretation of ECG, blood tests, and Holter monitor results
Management of heart failure and coronary artery disease
General medical issues: infections, fever, fatigue, gastrointestinal symptoms
Guidance on diagnostics, treatment plans, and medication adjustments

Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.

Book a video appointment

Yevgen Yakovenko

General surgery11 years of experience

Areas of medical expertise:

Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

12+ years of clinical experience in university hospitals in Germany and Spain.
International education: Ukraine – Germany – Spain.
Member of the German Society of Surgeons (BDC).
Certified in radiological diagnostics and robotic surgery.
Active participant in international medical conferences and research.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

Book a video appointment

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use GALAFOLD 123 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Galafold 123 mg Hard Capsules

Migalastat

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

What is Galafold and what is it used for
What you need to know before you take Galafold
How to take Galafold
Possible side effects
Storage of Galafold
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 older with certain genetic mutations (changes in genetic material).

Fabry disease is caused by a deficiency of an enzyme called alpha-galactosidase A (α-Gal A). Depending on the type of mutation (change in genetic material) of the gene that produces α-Gal A, the enzyme may not work properly or be completely absent. This enzyme deficiency leads to abnormal accumulations 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 work better to reduce the amount of GL-3 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

The 123 mg migalastat capsules are not indicated for children (≥12 years) weighing less than 45 kg.

Tell your doctor before taking Galafold if you are using enzyme replacement therapy.

Do not take Galafold if you are also using enzyme replacement therapy.

While taking Galafold, your doctor should assess your condition and whether your medicine is working every 6 months. If your condition worsens, your doctor should perform additional tests or stop treatment with Galafold.

Consult your doctor before taking Galafold if your kidney function is severely impaired, as Galafold is not recommended for use in patients with severe renal impairment (with an eGFR below 30 ml/min/1.73 m2).

Children

Children <12 years

This medicine has not been studied in children under 12 years of age. Therefore, the 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 obtained without a prescription, such as supplements or herbal medicines.

Tell your doctor especially if you take medicines or supplements that contain caffeine, as these medicines may affect the activity of Galafold if taken during the fasting period.

Be aware of the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

Pregnancy, breastfeeding, and fertility

Pregnancy

There are very limited data on the use of this medicine in pregnant women. Galafold is not recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Women who can become pregnant must use an effective method of contraception while using Galafold.

Breastfeeding

Do not take this medicine if you are breastfeeding until you have talked to your doctor, pharmacist, or nurse. It is not known if this medicine is excreted in breast milk. Your doctor will decide whether you should stop breastfeeding or stop treatment with Galafold, considering the benefit of breastfeeding for the baby and the benefit of Galafold for the mother.

Male fertility

It is not known if this medicine affects male fertility. The effects of Galafold on fertility in humans have not been studied.

Female fertility

It is not known if this medicine affects female fertility.

If you are planning to become pregnant, consult your doctor, pharmacist, or nurse.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

3. How to take Galafold

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

The recommended dose is one capsule every two days at the same time of day. Do not take Galafold on two consecutive days.

Do not eat any food or caffeine for at least 2 hours before and 2 hours after taking the medicine. This 4-hour fasting period around the time of taking the medicine is necessary to allow the medicine to be fully absorbed.

During the 4-hour fasting period, you can consume water (natural, flavored, sugared), fruit juices without pulp, and non-caffeinated carbonated drinks.

Swallow the capsules whole. Do not split, crush, or chew the capsules.

Figure A

Hands holding an auto-injector device with a transparent window showing the plunger and circular buttons

Step 1: Remove the adhesive strip that keeps the flap closed.

Lift the flap to open the Galafold carton (see Figure A).

Figure B: Open carton

Hands holding an informational booklet with illustrations of a medical device and usage steps indicated

Step 2: Press the purple tab with your thumb on the leftside of the carton without releasing it (see Figure B) and proceed to step 3.

Figure C

Hand holding a blister pack of tablets with black and white circles indicating dosage and administration sequence

Step 3: Now GRASP the tab on the rightside, where it says “PULL HERE”, and pull out the folded blister pack (see Figure C).

Figure D: Front of the blister pack

Strip of tablets with 12 oval capsules, some darkened to indicate dosage, held by two fingers

Step 4: Unfold the blister pack (see Figure D).

How to take the Galafold capsules:

One Galafold blister pack = 14 hard capsules = 28 days of treatment with Galafold and 14 white circles.

The white circles are to remind you to take Galafold every twodays.

The arrow indicates to the patient that they should start the next 2 weeks of treatment.

Figure E: Front of the blister pack

Blister pack with oval tablets marked with days 1 to 28 and an arrow indicating the start

Figure F: Front of the blister pack

Hand holding an auto-injector with date markers for days 1, 2, 4, 6, and 8 indicating injection progress

Step 5: On the first day you start with this medicine, mark the date on the new blister pack (see Figure F).

Figure G: Back of the blister pack

Hands opening a blister pack of tablets with a rectangular shape perforated with circles

Step 6: TURN OVER the blister pack to see the back.

LOCATE the capsule you are going to remove.

FOLD the blister pack as indicated here (see Figure G).

Note: When folding the blister pack, the perforated oval stands out.

Hand holding a syringe with a needle inserted into the skin showing the angle of injection and a shaded subcutaneous area Figure H: Back of the blister pack

Step 7: REMOVE the perforated oval (see Figure H).

Note: When removing the oval, the white backing sheet may still remain. This is correct.

Figure I: Front of the blister pack

Dotted oval outlining a white space with evenly distributed black dots around Finger pressing a pill calendar with days 2, 3, 4, 5, 6, and 7 marked and the start date indicated

Step 8: TURN OVER the blister pack to see the front.

PUSH the capsule to remove it (see Figure I).

Figure J: Front of the blister pack

Hand pressing a blister pack with tablets marked with days 1, 3, 5, and 6 along with circles for days 2, 4, and 6

Step 9: The next day, move to the white circle in the top row marked as Day 2.

Press the white circle to perforate it (see Figure J).

Note: Perforating this white circle will help you remember which days you should not take the medicine.

Take 1 Galafold capsule every twodays.

Close and store the box after each use.

After Day 2, move to Day 3 of the blister pack.

Alternate the days you take the capsule and perforate the white circles, until day 28, including this last day.

Figure K: Front of the unfolded blister pack

Monthly calendar with circles to mark days from day 1 to 27 and a box to indicate the date

If you take more Galafold than you should

If you take more capsules than you should, stop taking the medicine and consult 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 and remember later, you can take the capsule only if it is within the next 12 hours after the usual time you take the dose. If more than 12 hours have passed, you should take Galafold the next day at the usual time, according to the every-other-day dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Galafold

Do not stop treatment without talking to your doctor first.

If you have any further questions on 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.

Very common: may affect more than 1 in 10 people

Headache

Common: may affect up to 1 in 10 people

Palpitations (feeling of strong heartbeats)
Abnormal feeling of movement (vertigo)
Diarrhea
Nausea
Stomach pain
Constipation
Dry mouth
Sudden need to defecate (to go to the bathroom)
Indigestion (dyspepsia)

Fatigue
High levels of creatine phosphokinase in the blood
Weight gain
Muscle spasms
Muscle pain (myalgia)
Painful stiff neck (torticollis)
Numbness or tingling in the limbs (paresthesia)

Dizziness
Reduced sense of touch (hypoesthesia)
Depression
Protein in the urine (proteinuria)
Shortness of breath (dyspnea)
Nosebleeds (epistaxis)
Rash
Persistent itching (pruritus)
Pain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and blister pack after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Galafold

The active ingredient 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

Capsule shell: gelatin, titanium dioxide (E171), and indigo carmine (E132)

Printing ink: shellac, iron oxide black, and potassium hydroxide

Appearance of Galafold and Package Contents

Hard blue and white opaque capsules marked with «A1001» in black ink, hard capsule size 2 (6.4 x 18.0 mm) containing a white to light brown powder.

Galafold is available in a blister pack of 14 capsules.

Marketing Authorization 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

GALAFOLD 123 mg HARD CAPSULES

Abdullah Alhasan

Yevgen Yakovenko

Abdullah Alhasan

Yevgen Yakovenko

How to use GALAFOLD 123 mg HARD CAPSULES

Introduction

1. What is Galafold and what is it used for

2. What you need to know before you take Galafold

3. How to take Galafold

4. Possible side effects

5. Storage of Galafold

6. Package Contents and Additional Information

Alternatives to GALAFOLD 123 mg HARD CAPSULES in other countries

Alternative to GALAFOLD 123 mg HARD CAPSULES in Ukraine

Online doctors for GALAFOLD 123 mg HARD CAPSULES

Abdullah Alhasan

Yevgen Yakovenko

Nuno Tavares Lopes

Duarte Meneses

Ngozi Precious Okwuosa

Svetlana Kolomeeva

Sergio Correa

Roman Raevskii

Karim BenHarbi

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