GALAFOLD
ItalyIt is used for the long-term treatment of Fabry disease in adults and adolescents (from 12 years of age and older) who have certain genetic mutations. It works by stabilizing the enzyme naturally produced by the body to reduce the accumulation of a fatty substance (GL-3) in the organs.
Frequently asked questions
How should I take Galafold?
One capsule should be taken every other day, always at the same time. It is essential not to take the medicine for two consecutive days. The capsules must be swallowed whole, without being divided, chewed, or crushed. For correct absorption, a fast of at least 2 hours before and 2 hours after administration is required: during this period, no food or caffeine should be consumed (water, pulp-free fruit juices, and caffeine-free carbonated beverages are permitted).
When should I not take this drug?
You must not take Galafold if you are allergic to the active substance or to any of the other components, or if you are undergoing enzyme replacement therapy. It is not recommended for those with severely reduced renal function. Additionally, the capsules are not suitable for children (from 12 years of age and older) with a body weight of less than 45 kg.
What are the side effects of Galafold?
Very common side effects reported include headache. Common side effects may include palpitations, dizziness, weight gain, depression, diarrhea, nausea, stomach ache, constipation, dry mouth, urgent need to defecate, fatigue, muscle pain, shortness of breath, stiff neck, nosebleeds, tingling in the extremities, rash, or itching. In uncommon cases, sudden swelling of the lips, tongue, or eyes may occur.
What should I do if I forget a dose or take too much?
If you forget the capsule but remember within 12 hours of the usual time, you may take it. If more than 12 hours have passed, the dose should be skipped and the cycle should be resumed the following day and time, following the every-other-day schedule. Never take a double dose to compensate. If you take more Galafold than intended, you must discontinue treatment and contact a doctor immediately.
Are there interactions with other products or precautions for pregnancy?
It is important to inform your doctor if you are taking other medicines, supplements, or herbs, particularly if they contain caffeine, as this can affect the drug's function if taken during the fasting period. The drug is not recommended during pregnancy, and women of childbearing age must use an effective method of contraception. In the case of breastfeeding, it is necessary to consult a doctor.
Instructions for use
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Package leaflet: Information for the patient
Galafold 123 mg hard capsules
migalastat
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Galafold is and what it is used for
- What you need to know before taking Galafold
- How to take Galafold
- Possible side effects
- How to store Galafold
- Contents of the pack and other information
1. What Galafold is and what it is 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 who have specific genetic mutations (variations).
Fabry disease is caused by the absence or malfunction 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 either does not function properly or is completely absent. This enzymatic defect leads to abnormal accumulation 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 naturally produced by the body, enabling it to function more effectively and thereby reducing the accumulated amount of GL-3 in cells and tissues.
2. What you need to know before taking Galafold
Do not take Galafold
- if you are allergic to migalastat or to 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 body weight below 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 undergoing enzyme replacement therapy.
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Your doctor will monitor your condition and check whether the medicine is working every 6 months during
treatment with Galafold. If your condition worsens, your doctor may carry out further investigations or
discontinue treatment 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 under 12 years
As 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 obtained without a prescription, including supplements and herbal medicines.
In particular, inform your doctor if you are taking medicines or supplements containing caffeine, as these, if taken during the fasting period, may affect the effectiveness of Galafold.
You should be aware of the medicines you are taking. Keep a list and show it to your doctor and pharmacist each time you start 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, think you might be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
Women of childbearing potential must use an effective method of contraception during treatment 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. Your doctor will decide whether breastfeeding should be discontinued or treatment with Galafold should be temporarily stopped, taking into account the benefits of breastfeeding for the child and the benefits of Galafold for the mother.
Male fertility
It is not yet known whether this medicine affects male fertility. The effects of Galafold on male fertility have not been studied.
Female fertility
It is not yet known whether this medicine affects female fertility.
If you are planning a pregnancy, consult your doctor, pharmacist, or nurse.
Driving and using machines
This medicine is not expected to affect the ability to drive vehicles or operate machinery.
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3. How to take Galafold
Take this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Take one capsule every other day at the same time. Do not take Galafold on two consecutive days.
Do not consume food or caffeine at least 2 hours before and 2 hours after taking the medicine. This fasting period of at least 4 hours is necessary to ensure complete absorption of the medicine.
During the 4-hour fasting period, you may drink water (still, flavoured, sweetened), pulp-free fruit juices, and caffeine-free carbonated beverages.
Swallow the capsules whole. Do not divide, crush, or chew the capsule.
Figure A | 1: Remove the adhesive seal that keeps the cardboard box closed. Open the Galafold cardboard box (see Figure A). |
Figure B - Opened box | 2: Press and hold the purple tab on the left side of the box with your thumb (see Figure B), then proceed to step 3. |
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Figure C | 3: NOW GRASP the tab on the right side where it says “PULL HERE” and pull out the folded blister (see Figure C). | |
Figure D - Front of the blister | 4: Open the blister (see Figure D). | |
Taking Galafold capsules: One Galafold blister = 14 hard capsules = 28 days of Galafold treatment and 14 white circles. The white circles are to remind you to take Galafold on alternate days. The arrow indicates to the patient the start of the next two weeks of treatment. Figure E - Front of the blister | ||
Figure F - Front of the blister | 5: On the first day you take the medicine from a new blister, record the date on the blister itself (see Figure F). | |
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Figure G - Back of the blister | 6: TURN the blister over to the back side. IDENTIFY the capsule to be removed. FOLD the blister as shown (see Figure G). Note: Folding the blister helps to lift the perforated oval. |
Figure H - Back of the blister | 7: REMOVE the perforated oval (see Figure H). Note: After removing the oval, the white rear part of the aluminum foil may remain, but this is not a problem. |
Figure I - Front of the blister | 8: TURN the blister to the front side. PUSH the capsule out through the blister (see Figure I). |
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Figure J - Front of the blister | 9: On the following day, move to the perforated white circle in the top row marked "day 2". Press the white circle to remove it (see Figure J). Note: Removing the white circle will help you remember the day you did not take the medicine. Take 1 capsule of Galafold only on alternate days. Close the package and store it after each use. |
After day 2, proceed to day 3 on the blister. Alternate days by taking the capsule and removing the perforated white circles, continuing up to and including day 28. Figure K - Unfolded front of the blister | |
If you take more Galafold than you should
If you take more capsules than you should, you must 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 your usual time but remember later on the same day,
you may take the capsule only if no more than 12 hours have passed since your usual dosing time.
If more than 12 hours have passed, you should resume taking Galafold at the next scheduled dose according to the alternate-day dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Galafold
Do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
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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 (sensation of heartbeat or fast-beating heart)
- Creatine phosphokinase increased in blood tests
- Reduced tactile or sensory sensitivity (hypoesthesia)
- Dizziness (vertigo)
- Weight gain
- Depression
- Diarrhoea
- Muscle spasms
- Protein in urine (proteinuria)
- Nausea
- Muscle pain (myalgia)
- Shortness of breath (dyspnea)
- Constipation
- Painful stiff neck (torticollis)
- Nosebleed (epistaxis)
- Tingling sensation in extremities (paraesthesia)
- Rash
- Dizziness
- Persistent itching (pruritus)
- Indigestion (dyspepsia)
- Pain
- Dry mouth
- Urgent need to defecate
Uncommon: may affect up to 1 in 100 people
- Sudden swelling of the skin or mucosa (e.g. lips, tongue, eyes, etc.), or both (angioedema)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system indicated 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 stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions regarding temperature. Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Package Contents and Other Information
What Galafold Contains
- The active substance is migalastat. Each capsule contains migalastat hydrochloride equivalent to 123 mg of migalastat.
- The other components are:
Capsule contents: pregelatinized starch (maize), magnesium stearate
Capsule shell: gelatin, titanium dioxide (E171), indigotine, indigo carmine (E132)
Printing ink: shellac, black iron oxide, potassium hydroxide
Description of the Appearance of Galafold and Contents of the Package
White, blue, opaque hard capsules marked with “A1001” in black ink, size 2 hard capsules (6.4 x 18.0 mm) containing white to light brown powder. Galafold is available in blister packs containing 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
Email: [email protected]
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk, Co. Louth A91 P9KD
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder (if the Amicus representative cannot be reached by phone, please contact them via email at the address provided below):
België/Belgique/Belgien
Amicus Therapeutics Europe Limited
Tél/Tel: (+32) 0800 89172
Email: [email protected]
Lietuva
Amicus Therapeutics Europe Limited
Tel: (+370) 8800 33167
Email: [email protected]
България
Amicus Therapeutics Europe Limited
Tel: (+359) 00800 111 3214
Email: [email protected]
Luxembourg/Luxemburg
Amicus Therapeutics Europe Limited
Tél/Tel: (+352) 800 27003
Email: [email protected]
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Česká republika
Amicus Therapeutics Europe Limited
Tel: (+420) 800 142 207
Email: [email protected]
Magyarország
Amicus Therapeutics Europe Limited
Tel: (+36) 06 800 21202
Email: [email protected]
Danmark
Amicus Therapeutics Europe Limited
Tlf.: (+45) 80 253 262
Email: [email protected]
Malta
Amicus Therapeutics Europe Limited
Tel: (+356) 800 62674
Email: [email protected]
Deutschland
Amicus Therapeutics GmbH
Tel: (+49) 0800 000 2038
E-Mail: [email protected]
Nederland
Amicus Therapeutics BV
Tel: (+31) 0800 022 8399
Email: [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
Amicus Therapeutics Europe Limited
Tel: (+30) 00800 126 169
Email: [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
Email: [email protected]
Polska
Amicus Therapeutics Europe Limited
Tel: (+48) 0080 012 15475
Email: [email protected]
France
Amicus Therapeutics SAS
Tél: (+33) 0 800 906 788
Email: [email protected]
Portugal
Amicus Therapeutics Europe Limited
Tel: (+351) 800 812 531
Email: [email protected]
Hrvatska
Amicus Therapeutics Europe Limited
Tel: (+385) 0800 222 452
E-pošta: [email protected]
România
Amicus Therapeutics Europe Limited
Tel: (+40) 800 476 561
Email: [email protected]
Ireland
Amicus Therapeutics Europe Limited
Tel: (+353) 1800 936 230
Email: [email protected]
Slovenija
Amicus Therapeutics Europe Limited
Tel: (+386) 0800 81794
E-pošta: [email protected]
Ísland
Amicus Therapeutics Europe Limited
Sími: (+354) 800 7634
Netfang: [email protected]
Slovenská republika
Amicus Therapeutics Europe Limited
Tel: (+421) 0800 002 437
Email: [email protected]
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Italia
Amicus Therapeutics S.r.l.
Tel: (+39) 800 795 572
Email: [email protected]
Suomi/Finland
Amicus Therapeutics Europe Limited
Puh/Tel: (+421) 0800 917 780
Sähköposti/Email: [email protected]
Κύπρος
Amicus Therapeutics Europe Limited
Tel: (+357) 800 97595
Email: [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]
Additional Sources of Information
More detailed information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and their treatments are also provided.
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The original data is available in the language of the country of manufacture.
Data source: Italian Medicines Agency (AIFA)
Data last verified: September 21, 2026