123 mg hard capsules
migalastat
1. What Galafold is and what it is used for
Galafold contains the active substance migalastat.
This medicine is used in the long-term treatment of Fabry’s disease in adults and adolescents 12 years of age or older who have certain genetic mutations (changes).
Fabry disease is caused by a deficiency or an incorrect enzyme called alpha-galactosidase A (α-Gal A). Depending on the type of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent. This enzyme deficiency leads to abnormal storage of a fatty substance called globotriaosylceramide (GL-3) in the kidneys, heart, and other organs, causing the symptoms of Fabry’s disease.
This medicine works by stabilizing the enzyme that your body naturally produces so that it can better reduce the amount of GL-3 that has accumulated in your cells and tissues.
2. What you need to know before taking 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 cautions
123 mg migalastat capsules should not be given to children (under 12 years of age) weighing less than 45 kg.
Talk to your doctor before taking Galafold if you are currently undergoing enzyme replacement therapy. You should not take Galafold if you are also receiving enzyme replacement therapy.
While you are taking Galafold, your doctor will monitor your condition every 6 months to check if the medicine is working. If your condition worsens, your doctor may evaluate you further or discontinue your treatment with Galafold.
Talk to your doctor before taking Galafold if you have severe renal impairment as Galafold is not recommended for patients with severe renal impairment ( GFR less than 30 ml/min / 1.73 m 2 ).
Children and young people
Children over 12 years
This drug has not been studied in children and adolescents under 12 years of age; therefore, safety and efficacy have not been established for this age group.
Other drugs and Galafold
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding 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 of childbearing potential using Galafold should use a safe method of contraception.
Breast-feeding
If you are breastfeeding, do not take this medicine until you have talked to a doctor, pharmacist, or nurse. It is not known if this medicine passes into breast milk. Your doctor will decide if you need to stop breastfeeding or temporarily stop taking your medicine after taking into account the benefit of breastfeeding for your baby and the benefit of treatment for your mother.
Fertility in men
It is not known if this medicine affects the fertility of men. The effects of Galafold on human fertility have not been studied.
Fertility in women
It is not known if this medicine affects the fertility of women.
If you are planning to have children, consult a doctor, pharmacist, or nurse.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
3. How to take Galafold
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Take one capsule once every two days at the same time of day. Do not take Galafold for two days straight.
Do not eat at least 2 hours before and 2 hours after taking a dose. A fasting period of at least 4 hours is required for the drug to be completely absorbed into your body. Transparent liquids, including carbonated beverages, can be ingested during this period.
If you take more Galafold than you should
If you have taken too many capsules, stop taking the medicine and contact a doctor. You may have a headache and feel dizzy.
If you forget to take Galafold
If you have forgotten to take your capsule at the usual time but remember the latter, you can only take the capsule if no more than 12 hours have passed since the time the capsule was taken. If more than 12 hours have elapsed, continue to take Galafold on the day and time indicated for the next scheduled dose according to the dosing schedule. Do not take two capsules to make up for a forgotten dose.
If you stop taking Galafold
Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this product, 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
| Palpitation er (palpitations)Scams ( vertigo )DiarrheaNauseaMagontConstipationDry mouthSudden need for stoolsIndigestion ( dyspepsia )Fatigue | Increased levels of creatine phosphokinase in blood sample weight gain muscle cramps muscle pain ( myalgia )Painful stiff neck ( torticollis )Crawls in the extremity are ( paresthesia )DizzinessDecreased sensitivity to touch ( hypesthesia )Depression | Protein in the urine ( proteinuria )Shortness of breath ( dyspnoea )Nasal blood ( epistaxis )RashPersistent itching ( pruritus )Pain |
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package to protect the product from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
6. Contents of the packaging and other information
Content declaration
- The active substance is migalastat. Each capsule contains migalastate hydrochloride equivalent to 123 mg migalastate.
- Other ingredients are:Capsule content: Pregelatinized starch (maize) and magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171) and indigo carmine (E132)
Ink: Shellac, black iron oxide and potassium hydroxide
What the medicine looks like and contents of the pack
Opaque, blue and white hard capsules, marked with “A1001” in black, size 2 hard capsules (6.4 x 18.0 mm)
containing white to light 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
Email: info@amicusrx.co.uk
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk, Co. Louth
A91 P9KD
Ireland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine (if you are unable to reach your Amicus representative by phone, please use the email addresses provided below):
Amicus Therapeutics Europe Limited
Tel: (+46) 020 795 493