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VYNDAQEL 20 mg SOFT CAPSULES

VYNDAQEL 20 mg SOFT CAPSULES

Ask a doctor about a prescription for VYNDAQEL 20 mg SOFT CAPSULES

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use VYNDAQEL 20 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Vyndaqel 20mg soft capsules

tafamidis meglumine

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on 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.

Contents of the pack

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

1. What is Vyndaqel and what is it used for

Vyndaqel contains the active substance tafamidis.

Vyndaqel is a medicine used to treat a disease called transthyretin-related amyloidosis. Transthyretin-related amyloidosis is caused by a protein called transthyretin (TTR) not working properly. This is a protein that carries other substances, such as hormones, around the body.

In patients with this disease, the TTR breaks down and can form fibers called amyloid. The amyloid can build up around the nerves (known as transthyretin-related amyloidotic polyneuropathy or ATTR-PN) and other parts of the body. The amyloid causes the symptoms of this disease. When this happens, it prevents them from working normally.

Vyndaqel can prevent the TTR from breaking down and forming amyloid. This medicine is used to treat adult patients who have this disease and have nerve damage (people with symptomatic polyneuropathy) to delay the progression of the disease.

2. What you need to know before you take Vyndaqel

Do not take Vyndaqel

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with 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 are no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have symptoms of transthyretin-related 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is one 20 mg Vyndaqel capsule (tafamidis meglumine) 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, then 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 crushing or cutting.

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 Vyndaqelthan 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 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 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.

Very common: may affect more than 1 in 10 people:

  • Diarrhea.
  • Urinary tract infection (symptoms may include: pain or burning sensation when urinating or frequent need to urinate).
  • Stomach pain or abdominal pain.

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.

Do not store above 25°C.

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 20 mg of micronized tafamidis meglumine, equivalent to 12.2 mg of tafamidis.
  • The other ingredients are: gelatin (E 441), glycerol (E 422), sorbitol (E 420) (see section 2 "Vyndaqel contains sorbitol"), mannitol (E 421), sorbitan, yellow iron oxide (E 172), titanium dioxide (E 171), purified water, macrogol 400 (E 1521), sorbitan monooleate (E 494), polysorbate 80 (E 433), ethanol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), carmine (E 120), brilliant blue FCF (E 133), and ammonium hydroxide (E 527).

Appearance and packaging

Vyndaqel soft capsules are yellow, opaque, and oblong (approximately 21 mm) and are printed with "VYN 20" in red. 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 packs, each containing 30 x 1 soft capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

or

Millmount Healthcare Limited

Block-7, City North Business Campus

Stamullen

K32 YD60

Ireland

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

België/Belgique/BelgienLuxembourg/Luxemburg

Pfizer NV/SA

Tel/Tel: +32 (0)2 554 62 11

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel: +370 5 251 4000

????????

??????? ?????????? ????, ???? ????????

???.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: +36 1 488 37 00

Ceská republika

Pfizer, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: +356 21344610

Danmark

Pfizer ApS

Tlf.: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)800 63 34 636

Deutschland

PFIZER PHARMA GmbH

Tel: +49 (0)30 550055-51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλ?δα

Pfizer Ελλ?ς A.E.

Τηλ: +30 210 6785800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer, S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél +33 (0)1 58 07 34 40

România

Pfizer Romania S.R.L.

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s podrocja farmacevtske dejavnosti, Ljubljana

Tel: + 386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland Unlimited Company

Tel: +1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizacná zložka

Tel: + 421 2 3355 5500

Ísland

Icepharma hf.

Sími: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κ?προς

Pfizer Ελλ?ς Α.Ε. (Cyprus Branch)

Τηλ: +357 22817690

Latvija

Pfizer Luxembourg SARL filiale Latvija

Tel: +371 670 35 775

Date oflast revision of this leaflet: 02/2025.

This medicine has been authorized under exceptional circumstances.

This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicine.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

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.

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