VYNDAQEL 20 mg SOFT CAPSULES
How to use VYNDAQEL 20 mg SOFT CAPSULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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
- What is Vyndaqel and what is it used for
- What you need to know before you take Vyndaqel
- How to take Vyndaqel
- Possible side effects
- Storage of Vyndaqel
- 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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VYNDAQEL 20 mg SOFT CAPSULESDosage form: CAPSULE, 61 mg tafamidisActive substance: tafamidisManufacturer: Pfizer Europe Ma EeigPrescription requiredDosage form: INJECTABLE, 25 mgActive substance: vutrisiranManufacturer: Alnylam Netherlands B.V.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 300 mg/mlActive substance: sodium oxybateManufacturer: Accord Healthcare S.L.U.Prescription required
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