Galafold – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Galafold, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
ℹ️ 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 certain genetic mutations (changes).
Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A).
Depending upon the kind of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent. This enzyme defect leads to abnormal deposits of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease.
This medicine works by stabilising the enzyme that your body produces naturally, so that it can work better to reduce the amount of GL-3 that has accumulated in your 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
123 mg migalastat capsules are not for children (≥12 years) weighing less than 45 kg.
Talk to your doctor before taking Galafold if you are currently taking enzyme replacement therapy.
You should not take Galafold if you are also receiving enzyme replacement therapy.
Your doctor will monitor your condition and whether your medicine is working every 6 months while you are taking Galafold. If your condition worsens, your doctor may evaluate you further or may discontinue your treatment with Galafold.
VV-LAB-003881 – V1.0 52 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 insufficiency (GFR less than 30 mL/min/1.73m2).
Children
Children <12 years This medicine has not been studied in children under the age of 12; therefore, the safety and efficacy in this age group has 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.
Especially tell your doctor if you take caffeine containing medicines or supplements as these medicines may affect how Galafold works if taken during fasting period.
Know 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, breast-feeding, and fertility
Pregnancy
There is very limited experience with the use of this medicine in pregnant women. Galafold is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Women who could become pregnant should use effective birth control while taking Galafold.
Breast-feeding
Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse. It is not yet known whether this medicine passes into breast milk. Your doctor will decide whether you need to stop breast-feeding or temporarily stop your medicine, considering the benefit of breast-feeding to the baby and the benefit of Galafold to the mother.
Fertility in men It is not yet known if this medicine affects fertility in men. The effects of Galafold on fertility in humans have not been studied.
Fertility in women It is not yet known if this medicine affects fertility in women.
If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive and use machines.
💊 3. How to take Galafold
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure.
VV-LAB-003881 – V1.0 53 Take one capsule every other day at the same time of the day. Do not take Galafold on two consecutive days.
Do not consume food or caffeine at least 2 hours before and 2 hours after taking your medicine. This minimum 4 hours fast around taking your medicine is needed to allow your medicine to be fully absorbed.
Water (plain, flavored, sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the 4-hour fasting period.
Swallow the capsule whole. Do not cut, crush, or chew the capsule.
Figure A Step 1: Remove the adhesive seal holding the cover.
Lift the cover of your Galafold carton (see Figure A).
Figure B – Opened carton Step 2: Press and continue holding down the purple tab with your thumb at the left side of the carton (see Figure B), and continue to Step 3.
Figure C Step 3: Now GRASP the tab on the right side where it says “PULL OUT HERE” and pull out the folded blister card (see Figure C).
VV-LAB-003881 – V1.0 54 Figure D – Front of the blister card Step 4: Unfold the blister card (see Figure D).
Taking Galafold Capsule:
One Galafold blister card = 14 hard capsules = 28 days of treatment with Galafold, and 14 white cardboard circles.
The white cardboard circles are to remind you to take Galafold every other day.
The arrow directs the patient to begin the next 2 weeks of treatment.
Figure E – Front of the blister card Figure F – Front of the blister card Step 5: On your first day of taking this medicine from a new blister card, record the date on the blister card (see Figure F).
Figure G – Back of the blister card Step 6: TURN the card OVER showing the back of the card.
LOCATE capsule to remove.
BEND the card as shown (see Figure G).
Note: Bending the card helps raise the oval perforated cardboard.
VV-LAB-003881 – V1.0 55 Figure H – Back of the blister card Step 7: REMOVE the oval perforated cardboard (see Figure H).
Note: After removing the cardboard, the white backing of the foil may be present, which is ok.
Figure I – Front of the blister card Step 8: TURN the card OVER showing the front of the card.
PUSH the capsule out (see Figure I).
Figure J – Front of the blister card Step 9: On the next day, move to the perforated white cardboard circle on the top row labelled Day 2.
Press down on the white cardboard circle removing it (see Figure J).
Note: Removing this white circle will help you remember which day you do not take the medicine.
Take 1 Galafold capsule every other day.
Close package and store after each use.
VV-LAB-003881 – V1.0 56 After Day 2, move to Day 3 on the blister card.
Alternate daily between taking the capsule and pushing out the perforated white cardboard circles, up to and including day 28.
Figure K – Front of the unfolded blister card
If you take more Galafold than you should
If you take more capsules than you should, then you should stop taking the medicine and contact your doctor. You may get a headache and feel dizzy.
If you forget to take Galafold
If you forget to take your capsule at the usual time but remember later, you can take the capsule only if it is within 12 hours of your normal dosing time. If more than 12 hours has passed, you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule. Do not take two capsules to make up for your missed dose.
If you stop taking Galafold
Do not stop taking this medicine without talking to your doctor.
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 VV-LAB-003881 – V1.0 57 Common : may affect up to 1 in 10 people Palpitations (the feeling of a pounding heart) Sensation of spinning (vertigo) Diarrhoea Feeling sick (nausea) Stomachache Constipation Dry mouth Sudden need to defecate Indigestion (dyspepsia) Tiredness Raised levels of creatine phosphokinase in blood tests Weight gain Muscle spasms Muscle pain (myalgia) Painful stiff neck (torticollis) Tingling in extremities (paraesthesia) Dizziness Reduced sense of touch or sensation (hypoaesthesia) Depression Protein in the urine (proteinuria) Shortness of breath (dyspnoea) Nose bleed (epistaxis) Rash Persistent itch (pruritus) Pain
Uncommon: may affect up to 1 in 100 people
Sudden swelling of skin or mucous membrane (e.g. lip, tongue, eye etc) or both (angioedema)
Reporting of side effects
If you get 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 via 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. 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 carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 migalastat
- The other ingredients are:
Capsule contents: Pregelatinised starch (maize) and magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171), and indigo carmine (E132) Printing ink: Shellac, black iron oxide, and potassium hydroxide VV-LAB-003881 – V1.0
What Galafold looks like and contents of the pack
Opaque, blue, and white hard capsules, marked with “A1001” in black ink, size 2 hard capsule (6.4 x 18.0 mm) containing white to pale brown powder.
Galafold is available in a blister pack 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder (if you cannot reach your Amicus representative by phone please contact via the e-mail address listed below):
België/Belgique/Belgien Amicus Therapeutics 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 Amicus Therapeutics Europe Limited Tél/Tel: (+352) 800 27003 e-mail: [email protected] Česká republika 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 Amicus Therapeutics 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 Norge Amicus Therapeutics Europe Limited VV-LAB-003881 – V1.0 Tel: (+372) 800 0111 911 e-post: [email protected] Tlf: (+47) 800 13837 e-post: [email protected] Ελλάδα Amicus Therapeutics 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 Amicus Therapeutics SAS Tél: (+33) 0 800 906 788 e-mail: [email protected] Portugal Amicus Therapeutics Europe Limited Tel: (+351) 800 812 531 e-mail: [email protected] Hrvatska Amicus Therapeutics Europe Limited Tel: (+385) 0800 222 452 e-pošta: [email protected] Ireland Amicus Therapeutics Europe Limited Tel: (+353) 1800 936 230 e-mail: [email protected] România Amicus Therapeutics Europe Limited Tel.: (+40) 800 476 561 e-mail: [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 e-mail: [email protected] Italia Amicus Therapeutics S.r.l.
Tel: (+39) 800 795 572 e-mail: [email protected] Suomi/Finland Amicus Therapeutics Europe Limited Puh/Tel: (+358) 0800 917 780 sähköposti/e-mail: [email protected] Κύπρος Amicus Therapeutics 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]
This leaflet was last revised in
Other sources of information VV-LAB-003881 – V1.0 Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
VV-LAB-003881 – V1.0
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Galafold (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1082).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.