VYNDAQEL 61 mg Soft Capsules

2. What you need to know before you take Vyndaqel

Do not take Vyndaqel

If you are allergic to tafamidis or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Vyndaqel.

• Women who may become pregnant should use a contraceptive method while taking Vyndaqel and should continue to use it for 1 month after stopping treatment with Vyndaqel. There is no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have symptoms of transthyretin amyloidosis. Therefore, Vyndaqel is not used in children and adolescents.

Other medicines and Vyndaqel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You should tell your doctor or pharmacist if you are taking any of the following medicines:

• Non-steroidal anti-inflammatory medicines
• Diuretic medicines (e.g., furosemide, bumetanide)
• Cancer medicines (e.g., methotrexate, imatinib)
• Statins (e.g., rosuvastatin)
• Antiviral medicines (e.g., oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Do not take Vyndaqel if you are pregnant or breastfeeding.
• If you can become pregnant, you should use a contraceptive method during treatment and for 1 month after stopping treatment.

Driving and using machines

Vyndaqel is not expected to affect your ability to drive or use machines.

Vyndaqel contains sorbitol

This medicine contains a maximum of 44 mg of sorbitol in each capsule. Sorbitol is a source of fructose.

3. How to take Vyndaqel

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one 61 mg Vyndaqel capsule (tafamidis) once a day.

If you vomit after taking the medicine and can see the Vyndaqel capsule intact, you should take another dose of Vyndaqel on the same day; if you cannot see the Vyndaqel capsule, you do not need to take another dose of Vyndaqel, but can take the medicine the next day as usual.

Method of administration

Vyndaqel is for oral use.

The soft capsule should be swallowed whole, without being crushed or cut.

The capsule can be taken with or without food.

Instructions for opening the blisters

• Separate a single blister from the blister card along the perforated line.
• Press the capsule through the aluminum foil.

If you take more Vyndaqel than you should

Do not take more capsules than your doctor has told you. If you take more capsules than you should, talk to your doctor.

If you forget to take Vyndaqel

If you forget to take a dose, take the capsule as soon as you remember. If it is less than 6 hours before the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vyndaqel

Do not stop taking Vyndaqel without talking to your doctor first. Since Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized and your disease may get worse.

If you have any other questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

• Diarrhea
• Rash, itching

In clinical studies, side effects in patients who took Vyndaqel were generally similar to those in patients who did not take Vyndaqel. In patients with ATTR-CM, flatulence and increased liver function test results were reported more frequently.

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. Storage of Vyndaqel

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 blister and carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vyndaqel contains

• The active substance is tafamidis. Each capsule contains 61 mg of micronized tafamidis.

• The other ingredients are: gelatin (E 441), glycerin (E 422), sorbitol (E 420) (see section 2 "Vyndaqel contains sorbitol"), mannitol (E 421), sorbitan, red iron oxide (E 172), purified water, macrogol 400 (E 1521), polysorbate 20 (E 432), povidone (K-value 90), butylhydroxytoluene (E 321), ethanol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171), and ammonium hydroxide (E 527).

Appearance and packaging

Vyndaqel soft capsules are reddish-brown, opaque, and oblong (approximately 21 mm) and are printed with "VYN 61" in white. Vyndaqel is available in two pack sizes of unit-dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules consisting of 3 cartons, each containing 30 x 1 soft capsules. Not all pack sizes may be marketed.

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 02/2025.

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 web sites about rare diseases and orphan medicines.

If you have difficulty seeing or reading this leaflet, or if you want it in a different format, please contact the local representative of the marketing authorisation holder listed in this leaflet.