Label: information for the user

Vyndaqel 61mg soft capsules

tafamidis

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this label. See section4.

Vyndaqel contains the active ingredient tafamidis.

Vyndaqelis a medication used to treat a disease called transthyretin amyloidosis. Transthyretin amyloidosis is caused by a malfunctioning protein called transthyretin (TTR). This is a protein that transports other substances, such as hormones, throughout the body.

In patients with this disease, the TTR breaks down and can form fibers called amyloid. The amyloid can accumulate between the heart cells (known as transthyretin cardiac amyloidosis (ATTR-CM) and other areas of the body. The amyloid causes the symptoms of this disease. When this occurs, it prevents the heart from functioning normally.

Vyndaqelmay prevent the TTR from breaking down and forming amyloid. This medication is used to treat adult patients with heart involvement (people with symptomatic cardiomyopathy).

Do not take Vyndaqel

If you are allergic to tafamidis or to any of the other components of this medication (including those listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vyndaqel.

• Women of childbearing potential should use a contraceptive method while taking Vyndaqel and should continue to use it for one month after discontinuing treatment with Vyndaqel. There are no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have symptoms of transtiretina amyloidosis. Therefore, Vyndaqelis not used in children and adolescents.

Other medications and Vyndaqel

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should inform your doctor or pharmacist if you are taking any of the following medications:

• Nonsteroidal anti-inflammatory drugs
• Diuretics (e.g., furosemide, bumetanide)
• Cancer medications (e.g., methotrexate, imatinib)
• Statins (e.g., rosuvastatin)
• Antiviral medications (e.g., oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• You should not take Vyndaqelif you are pregnant or breastfeeding.
• If you can become pregnant, you should use a contraceptive method during treatment and for one month after discontinuing it.

Driving and operating machinery

It is believed that the effect ofVyndaqel on the ability to drive and operate machinery is negligible or insignificant.

Vyndaqel contains sorbitol

This medication contains a quantity of sorbitol not exceeding 44mg per capsule. Sorbitol is a source of fructose.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Administration Form

Vyndaqel is for oral use.

The soft capsule should be swallowed whole, without crushing or cutting it.

The capsule can be taken with or without food.

Instructions for Opening the Blister Packs

• Separate an individual blister pack from the blister pack card along the perforated line.
• Press the capsule through the aluminum foil.

If You Take More VyndaqelThan You Should

You should not take more capsules than your doctor indicates. If you take more capsules than indicated, consult your doctor.

If You Forget to Take Vyndaqel

If you forget to take a dose, take the capsule as soon as you remember. If there are less than 6hours until 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 the missed doses.

If You Interrupt Treatment with Vyndaqel

Do not stop taking Vyndaqelwithout consulting your doctor first. Since Vyndaqelacts by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized and your disease may worsen.

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

Frequent:may affect up to 1 in 10 people

• Diarrhea
• Rash, itching

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the case. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Vyndaqel

• The active ingredient istafamidis. Each capsule contains 61mg of micronized tafamidis.

• The other components are:gelatine(E441), glycerin(E422), sorbitol(E420) (see section2 “Vyndaqel contains sorbitol”), mannitol(E421), sorbitan, iron oxide red (E172),purified water, macrogol400 (E1521), polysorbate20(E432), povidone (K90), butylhydroxytoluene (E321), ethanol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol(E1520), titanium dioxide (E171) and ammonium hydroxide (E527).

Appearance of the product and contents of the pack

Vyndaqel capsules are brown-red, opaque and oblong (approximately 21mm) and have “VYN61” printed in white. Vyndaqel is available in two sizes of blister packs: a pack of 30x1 capsules and a multiple pack of 90capsules formed by 3units, each containing 30x1 capsule. Only some pack sizes may be marketed.

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics: 02/2025.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicinal products.

If you find it difficult to read or see this leaflet or if you would like it in a different format, please contact the local representative of the marketing authorisation holder whose details are in this leaflet.