Introduction

Prescribing Information for the Patient

Galafold 123 mg Hard Capsules

Migalastat

Read this entire prescribing information carefully before starting to take this medicine, as it contains important information for you.

Keep this prescribing information, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

1. What is Galafold and how is it used

Galafold contains the active ingredient migalastat.

This medication is used for the long-term treatment of Fabry disease in adults and adolescents 12 years of age and older who carry certain genetic mutations (changes in the 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 the genetic material) of the gene that produces α-Gal A, the enzyme may not function correctly or be entirely absent. This enzyme deficiency causes abnormal accumulations of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease.

This medication works by stabilizing the enzyme that the body naturally produces, allowing it to function better to reduce the amount of GL-3 accumulated in cells and tissues.

2. What you need to know before starting Galafold treatment

Do not take Galafold:

if you are allergic to migalastat or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

45 kg of body weight.

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

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

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

Consult your doctor before taking Galafold if your renal function is severely impaired, as Galafold is not recommended for patients with severe renal insufficiency (with a GFR below 30ml/min/1.73m2).

Children

Children <12>

This medication has not been studied in children under 12 years of age. Consequently, the safety and efficacy have not been established in this age range.

Other medications and Galafold

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may take any other medication.This includes over-the-counter medications, such as supplements or herbal medications.

Inform your doctor especially if you take medications or supplements containing caffeine, as these medications may affect Galafold activity if taken during fasting.

Be aware of the medications you take. Keep a list of them and show it to your doctor and pharmacist each time you obtain a new medication.

Pregnancy, breastfeeding, and fertility

Pregnancy

There are very limited data regarding the use of this medication in pregnant women. Galafold is not recommended during pregnancy. If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Women who may become pregnant should use an effective contraceptive method while using Galafold.

Breastfeeding

Do not take this medication if you are breastfeeding your child until you have consulted with your doctor, pharmacist, or nurse. It is not known whether this medication is excreted in breast milk. Your doctor will decide whether you should discontinue breastfeeding or temporarily suspend treatment, considering the benefits of breastfeeding for the baby and the benefits of Galafold for the mother.

Male fertility

It is not known whether this medication affects male fertility. Galafold has not been studied in human fertility.

Female fertility

It is not known whether this medication affects female fertility.

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

Driving and operating machinery

This medication is not expected to affect your ability to drive and operate machinery.

3. How to Take Galafold

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

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

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

During the 4-hour fasting period, you can consume water (natural, flavored, sweetened), fruit juice without pulp, and caffeine-free carbonated beverages.

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

Figure A	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	Step 2: Press the purple button with your thumb on the left side of the carton without releasing it (see Figure B) and proceed to step 3.
Figure C	Step 3: Now GRAB the button by the right side, where it says “PULL FROM HERE”, and remove the folded blister (see Figure C).
Figure D: Frontal face of the blister	Step 4: Unfold the blister (see Figure D).
How to take Galafold capsules: One Galafold blister = 14 hard capsules = 28 days of Galafold treatment and 14 white circles. The white circles serve to remind you to take Galafold every two days. The arrow indicates the patient to start the next 2 weeks of treatment. Figure E: Frontal face of the blister
Figure F: Frontal face of the blister	Step 5: On the first day you start with this medication, mark the date on the new blister. (see Figure F).
Figure G: Back face of the blister	Step 6: TURN THE BLISTER OVER to see the back face. LOCATE the capsule to be extracted. DOUBLES the blister as indicated here (see Figure G). Nota: When DOUBLING the blister, the perforated oval protrudes.
Figure H: Back face of the blister	Step 7: REMOVE the perforated oval (see Figure H). Nota: When removing the oval, it is possible that the white support sheet remains. This is correct.
Figure I: Frontal face of the blister	Step 8: TURN THE BLISTER OVER to see the frontal face. PUSH the capsule to remove it (see Figure I).
Figure J: Frontal face of the blister	Step 9: The next day, move to the white circle from the top row marked as Day 2. Press the white circle to perforate it (see Figure J). Nota: Perforating this white circle will help you remember which days not to take the medication. Take 1 Galafold capsule every two days. Close and store the box after each use.
After Day 2, move to Day 3 of the blister. Alternate the days you take the capsule and perforate the white circles, until Day 28, inclusive. Figure K: Frontal face of the unfolded blister

If you take more Galafold than you should

If you take more capsules than you should, stop taking the medication and consult your doctor. You may experience headaches 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 12-hour interval following the usual time to take the dose. If more than 12 hours have passed, you should resume Galafold on the corresponding day and at the usual time, according to the dosing schedule of alternate days. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Galafold

You should not interrupt treatment without first speaking with your doctor.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very Common: may affect more than 1 in 10 people

Headache

Common: may affect up to 1 in 10 people

Palpitations (sensation of strong heartbeats)
Abnormal sensation of movement (dizziness)
Diarrhea
Nausea
Stomach pain
Constipation
Dry mouth
Urgent need to defecate (to go to the bathroom)
Indigestion (dyspepsia)

Fatigue
High levels of creatine phosphokinase in blood
Weight gain
Muscle spasms
Muscle pain (myalgia)
Painful neck stiffness (torticollis)
Tickling sensation in the extremities (paresthesia)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safetyof this medication.

5. Galafold Storage

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Galafold Composition

The active ingredient is migalastat. Each capsule contains migalastat hydrochloride equivalent to 123 mg of migalastat
The other components are:

Capsule content: pregelatinized maize starch and magnesium stearate

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

Printing ink: shellac, iron oxide black and potassium hydroxide

Appearance of Galafold and packaging 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

e-mail:[email protected]

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk, Co. Louth

A91 P9KD

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder (if you cannot contact your Amicus representative by phone, please contact us via the following email address):

Belgium

Amicus Therapeutics Europe Limited

Tel: (+32) 0800 89172

Galafold 123 mg capsulas duras

Introduction

1. What is Galafold and how is it used

2. What you need to know before starting Galafold treatment

3. How to Take Galafold

4. Possible Adverse Effects

5. Galafold Storage

6. Contents of the packaging and additional information

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