Galafold - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

What is in 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 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 (a-Gal A). Depending upon the kind of mutation (change) in the gene that produces a-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.

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.

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.

Take one capsule every other day at the same time of the day. Do not take Galafold on two consecutive days.

Do not eat food 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. Clear liquids, including carbonated drinks, can be consumed during this 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 z. yF~	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.
iooi |o<21 Io cl Voal ytt lli II»* 1 © 1 Vii w" <y»i teW \ tow. < \ I Ain 1 w 1 uWvj^’ u o ©) i-H	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).
Figure D – Front of the blister card _____________­________________________­________________________­________________________­____________,_,_________­________________________­________________________­________________________­_________________ 11 ggggggg „„„„„„ jj98BB8B8 IgBBBBBBj	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.

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.

Step 8: TURN the card OVER showing the front of the card.

PUSH the capsule out (see Figure I).

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.

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

Common : may affect up to 1 in 10 people

	Palpitations (the feeling		Weight gain		Shortness of breath
	of a pounding heart)		Muscle spasms		(dyspnoea)
	Sensation of spinning		Muscle pain (myalgia)		Nose bleed (epistaxis)
	(vertigo)		Painful stiff neck		Rash
	Diarrhoea		(torticollis)		Persistent itch (pruritus)
	Feeling sick (nausea)		Tingling in extremities		Pain
	Stomachache		(paraesthesia)
	Constipation		Dizziness
	Dry mouth		Reduced sense of touch
	Sudden need to defecate		or sensation
	Indigestion (dyspepsia)		(hypoaesthesia)
	Tiredness		Depression
	Raised levels of creatine		Protein in the urine
	phosphokinase in blood tests		(proteinuria)

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:

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:

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):

EXXáSa Amicus Therapeutics Europe Limited Tn^: (+30) 00800 126 169 e-mail:	Österreich Amicus Therapeutics Europe Limited Tel: (+43) 0800 005 475 E-Mail:
España Amicus Therapeutics S.L.U. Tel: (+34) 900 941 616 e-mail:	Polska Amicus Therapeutics Europe Limited Tel.: (+48) 0080 012 15475 e-mail:
France Amicus Therapeutics SAS Tél: (+33) 0 800 906 788 e-mail:	Portugal Amicus Therapeutics Europe Limited Tel: (+351) 800 812 531 e-mail:
Hrvatska Amicus Therapeutics Europe Limited Tel: (+358) 0800 222 452 e-posta:	Romania Amicus Therapeutics Europe Limited Tel.: (+40) 0808 034 288 / 877 309 5040 e-mail:
Ireland Amicus Therapeutics Europe Limited Tel: (+353) 1800 936 230 e-mail:	Slovenija Amicus Therapeutics Europe Limited Tel.: (+386) 0800 81794 e-pošta:
Ísland Amicus Therapeutics Europe Limited Sími: (+354) 800 7634 Netfang:	Slovenská republika Amicus Therapeutics Europe Limited Tel: (+421) 0800 002 437 e-mail:
Italia Amicus Therapeutics S.r.l. Tel: (+39) 800 795 572 e-mail:	Suomi/Finland Amicus Therapeutics Europe Limited Puh/Tel: (+358) 0800 917 780 sähköposti/e-mail:
Kúnpo^ Amicus Therapeutics Europe Limited Tn^: (+357) 800 97595 e-mail:	Sverige Amicus Therapeutics Europe Limited Tfn: (+46) 020 795 493 e-post:
Latvija Amicus Therapeutics Europe Limited Tel: (+371) 800 05391 e-pasts:	United Kingdom (Northern Ireland) Amicus Therapeutics, UK Limited Tel: (+44) 175 3888 567 / (+44) 08 0823 46864 e-mail:

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:. There are also links to other websites about rare diseases and treatments.

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