Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - galafold

Document Subject

Generated Narrative: MedicinalProductDefinition mp15a73917bf3a8bd9b5488de0aa2b271d

identifier: http://ema.europa.eu/identifier/EU/1/15/1082/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Galafold 123 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-15a73917bf3a8bd9b5488de0aa2b271d

identifier: http://ema.europa.eu/identifier/EU/1/15/1082/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - galafold

Attesters

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

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

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. 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.

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 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). 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. 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. 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.

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 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

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.

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.

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

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 0Fax: +353 (0) 1 588 6e-mail: info@amicusrx.co.uk

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):

Belgi /Belgique/Belgien Amicus Therapeutics Europe Limited T l/Tel: (+32) 0800 89e-mail: MedInfo@amicusrx.com

Lietuva Amicus Therapeutics Europe Limited
Tel: (+370) 8800 33El. pa tas: MedInfo@amicusrx.com

Amicus Therapeutics Europe Limited
Te .: (+359) 00800 111 3 : MedInfo@amicusrx.com

Luxembourg/Luxemburg Amicus Therapeutics Europe Limited
T l/Tel: (+352) 800 27e-mail: MedInfo@amicusrx.com esk republika Amicus Therapeutics Europe Limited
Tel.: (+420) 800 142 e-mail: MedInfo@amicusrx.com

Magyarorsz g Amicus Therapeutics Europe Limited
Tel.: (+36) 06 800 21e-mail: MedInfo@amicusrx.com Danmark Amicus Therapeutics Europe Limited
Tlf.: (+45) 80 253 e-mail: MedInfo@amicusrx.com

Malta Amicus Therapeutics Europe Limited
Tel: (+356) 800 62e-mail: MedInfo@amicusrx.com

Deutschland Amicus Therapeutics GmbH Tel: (+49) 0800 000 2E-Mail: MedInfo@amicusrx.com

Nederland Amicus Therapeutics BV Tel: (+31) 0800 022 8e-mail: MedInfo@amicusrx.com Eesti Amicus Therapeutics Europe Limited
Tel: (+372) 800 0111 e-post: MedInfo@amicusrx.com

Norge Amicus Therapeutics Europe Limited
Tlf: (+47) 800 13e-post: MedInfo@amicusrx.com

Amicus Therapeutics Europe Limited
: (+30) 00800 126 e-mail: MedInfo@amicusrx.com

sterreich Amicus Therapeutics Europe Limited
Tel: (+43) 0800 909 E-Mail: MedInfo@amicusrx.com Espa a Amicus Therapeutics S.L.U. Tel: (+34) 900 941 e-mail: MedInfo@amicusrx.com

Polska Amicus Therapeutics Europe Limited
Tel.: (+48) 0080 012 15e-mail: MedInfo@amicusrx.com France Amicus Therapeutics SAS T l: (+33) 0 800 906 e-mail: MedInfo@amicusrx.com

Portugal Amicus Therapeutics Europe Limited
Tel: (+351) 800 812 e-mail: MedInfo@amicusrx.com Hrvatska Amicus Therapeutics Europe Limited
Tel: (+358) 0800 222 e-po ta: MedInfo@amicusrx.com

Ireland Amicus Therapeutics Europe Limited
Tel: (+353) 1800 936 e-mail: MedInfo@amicusrx.com

Rom nia Amicus Therapeutics Europe Limited
Tel.: (+40) 0808 034 e-mail: MedInfo@amicusrx.com

Slovenija Amicus Therapeutics Europe Limited
Tel.: (+386) 0800 81e-po ta: MedInfo@amicusrx.com

sland Amicus Therapeutics Europe Limited
S mi: (+354) 800 7Netfang: MedInfo@amicusrx.com Slovensk republika Amicus Therapeutics Europe Limited
Tel: (+421) 0800 002 e-mail: MedInfo@amicusrx.com

Italia Amicus Therapeutics S.r.l. Tel: (+39) 800 795 e-mail: MedInfo@amicusrx.com

Suomi/Finland Amicus Therapeutics Europe Limited
Puh/Tel: (+358) 0800 917 s hk posti/e-mail: MedInfo@amicusrx.com

Amicus Therapeutics Europe Limited
: (+357) 800 97e-mail: MedInfo@amicusrx.com

Sverige Amicus Therapeutics Europe Limited
Tfn: (+46) 020 795 e-post: MedInfo@amicusrx.com

Latvija Amicus Therapeutics Europe Limited
Tel: (+371) 800 05e-pasts: MedInfo@amicusrx.com

United Kingdom (Northern Ireland) Amicus Therapeutics, UK Limited
Tel: (+44) 08 0823 46e-mail: MedInfo@amicusrx.com

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: