English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Galafold (migalastat hydrochloride) – Package leaflet - Amicus Therapeu

Updated on site: 07-Oct-2017

Medication nameGalafold
ATC CodeAmicus Therapeu
Substancemigalastat hydrochloride
ManufacturerAuthorised

Package leaflet: Information for the patient

Galafold 123 mg hard capsules

Migalastat

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 16 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

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.

Children and adolescents

This medicine has not been studied in children and adolescents under the age of 16 years; 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 because certain other medicines may increase or decrease the amount of Galafold in your body.

Pregnancy, breast-feeding, and fertility

Pregnancy

There is very limited experience with the use of this medicine in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine until you have checked with your doctor, pharmacist, or nurse. While taking Galafold you should use effective birth control.

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.

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.

Take the medicine on an empty stomach, at least 2 hours before eating. If you have just eaten, wait for 2 hours before taking the capsule. This is because your body may not absorb the medicine completely if taken with food.

Swallow the capsule whole. Do not cut, crush, or chew the capsule.

One Galafold blister sleeve = 14 hard capsules = 28 days of therapy

On your first day of taking this medicine from a new blister sleeve, record the date on the blister sleeve.

Then, punch out the left-most capsule labelled Day 1.

On the next day, punch out the perforated white circle labelled Day 2. This will help you remember which day you did not take the medicine. You should only take Galafold once every other day.

After Day 2, continue moving right on the blister sleeve.

Alternate daily between taking the capsule on odd numbered days and

punching out the perforated white circles on even numbered days, up to and including day 28.

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 that day, take the capsule when you remember on the same day. If you miss a dose of this medicine for an entire day, do not take the missed capsule. Wait and take the next capsule on the next day and time when you would usually take this medicine. 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

Muscle spasms

Rash

 

of a pounding heart)

Muscle pain (myalgia)

Persistent itch (pruritus)

Sensation of spinning

Painful stiff neck

Pain

 

(vertigo)

 

(torticollis)

 

 

Diarrhoea

Tingling in extremities

 

 

Feeling sick (nausea)

 

(paraesthesia)

 

 

Stomach ache

Dizziness

 

 

Constipation

Reduced sense of touch

 

 

Dry mouth

 

or sensation

 

 

Sudden need to defecate

 

(hypoaesthesia)

 

 

Indigestion (dyspepsia)

Depression

 

 

Tiredness

Protein in the urine

 

 

• raised levels of creatine

 

(proteinuria)

 

 

 

phosphokinase in blood

Shortness of breath

 

 

 

tests

 

(dyspnoea)

 

 

Weight gain

Nose bleed (epistaxis)

 

 

 

 

 

 

 

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 maize starch and magnesium stearate Capsule shell: Gelatin, titanium dioxide, and indigotine

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, containing white to pale brown powder.

Galafold is available in a blister pack containing 14 capsules.

Marketing Authorisation Holder

Amicus Therapeutics UK Ltd Phoenix House,

Oxford Road,

Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP

United Kingdom

tel +44 1753 888 567 fax +44 1753 437 192

e-mail info@amicusrx.co.uk

Manufacturer

Almac Pharma Services Limited

Seagoe Industrial Estate

Portadown, Craigavon

BT63 5UA

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tél/Tel: 080079245

Tel: 880033167

България

Luxembourg/Luxemburg

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Teл.: 008001113214

Tél/Tel: 80027003

Česká republika

Magyarország

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tel: 800142207

Tel.: 0680021202

Danmark

Malta

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tlf: 80253262

Tel: 80062674

Deutschland

Nederland

Amicus Therapeutics GmbH

Amicus Therapeutics BV

Tel: + 49 89 2488 798 10

Tel: + 31 20 235 8510

Eesti

Norge

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tel: 8000111911

Tlf: 80013837

Ελλάδα

Österreich

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Τηλ: 00800126169

Tel: 0800005475

España

Polska

Amicus Therapeutics S.L.U

Amicus Therapeutics, UK Ltd

Tel: +34 900 941 616

Tel.: 008001215475

France

Portugal

Amicus Therapeutics SAS

Amicus Therapeutics, UK Ltd

Tél: +33 800 906 788

Tel: 800812531

Hrvatska

România

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tel: 0800222452

Tel: + 0808 03 4288, 877-309-5040

Ireland

Slovenija

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tel: 1800936230

Tel: 080081794

Ísland

Slovenská republika

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Sími: 8007634

Tel: 0800002437

Italia

Suomi/Finland

Amicus Therapeutics S.r.l.

Amicus Therapeutics, UK Ltd

Tel: 800795572

Puh/Tel: 0800917780

 

Κύπρος

Sverige

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Τηλ: + 44 1753 888 567

Tel: 020795493

Latvija

United Kingdom

Amicus Therapeutics, UK Ltd

Amicus Therapeutics, UK Ltd

Tel: 80005391

Tel: 08082346864

This leaflet was last revised in

Other sources of information

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.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed