Vyndaqel 61 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vyndaqel 61 mg soft capsules

tafamidis

This medicinal product is subject to additional monitoring, which will allow rapid identification of new information on its safety. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, nurse, or pharmacist, even if such reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Vyndaqel is and what it is used for
2. What you need to know before taking Vyndaqel
3. How to take Vyndaqel
4. Possible side effects
5. How to store Vyndaqel
6. Contents of the pack and other information

1. What Vyndaqel is and what it is used for

Vyndaqel contains the active substance tafamidis.

Vyndaqel is a medicine used to treat a disease called transthyretin amyloidosis. Transthyretin amyloidosis is caused by improper functioning of a protein called transthyretin (TTR). This protein transports other substances, such as hormones, throughout the body.

In patients with this disease, TTR breaks down and may form fibres known as amyloid. Amyloid can accumulate between the cells of the heart (known as transthyretin amyloid cardiomyopathy (ATTR-CM)) and in other parts of the body. The amyloid causes the symptoms of this disease. When this occurs, it prevents the heart from functioning normally.

Vyndaqel can prevent the breakdown of TTR and the formation of amyloid. This medicine is used for the treatment of adult patients with cardiac involvement (individuals with symptomatic cardiomyopathy).

2. What you need to know before starting to take Vyndaqel

Do not take Vyndaqel

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

Warnings and precautions

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

• Women who could become pregnant must use a contraceptive method while taking Vyndaqel and continue using it for one month after stopping treatment with Vyndaqel. There are no data regarding the use of Vyndaqel in pregnant women.

Children and adolescents

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

Other medicines and Vyndaqel

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

You must inform your doctor or pharmacist if you are taking any of the following medicines:

• Non-steroidal anti-inflammatory drugs
• Diuretic medicines (e.g., furosemide, bumetanide)
• Medicines to treat cancer (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 become pregnant, consult your doctor or pharmacist before using this medicine.

• You must not take Vyndaqel if you are pregnant or breastfeeding.
• If you could become pregnant, you must use a contraceptive method during treatment and for one month after stopping treatment.

Driving and using machines

Vyndaqel is considered to have no or negligible influence on the ability to drive and use machines.

Vyndaqel contains sorbitol

This medicine contains up to 44 mg of sorbitol per capsule. Sorbitol is a source of fructose.

3. How to take Vyndaqel

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

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

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, then it is not necessary to take another dose; you may take your next dose as usual the following day.

Method of administration

Vyndaqel is for oral use.

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

The capsule may be taken with or without food.

Instructions for opening the blister packs

• Separate an individual blister from the blister card along the perforated line.
• Push the capsule through the aluminium foil.

If you take more Vyndaqel than you should

Do not take more capsules than your doctor has prescribed. If you take more capsules than prescribed, contact your doctor.

If you forget to take Vyndaqel

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

If you stop taking Vyndaqel

Do not stop taking Vyndaqel without first consulting your doctor. Since Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized and your condition may worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 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 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and carton. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Vyndaqel

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

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

Appearance of the product and contents of the container

Vyndaqel soft capsules are reddish-brown, opaque, and oblong (approximately 21 mm) with “VYN 61” printed in white. Vyndaqel is available in two sizes of unit-dose blister packs made of PVC/PA/Alu/PVC-Alu: a pack containing 30 x 1 soft capsules and a multiple pack containing 90 soft capsules, consisting of 3 boxes each containing 30 x 1 soft capsules. Only certain pack sizes may be marketed.

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet: 02/2025.

Other sources of information

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

If you have difficulty seeing or reading this leaflet, or if you would like it in a different format, please contact the local number of the marketing authorization holder listed in this leaflet.