Vyndaqel – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Vyndaqel, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
ℹ️ 1. What Vyndaqel is and what it is used for
Vyndaqel contains the active substance tafamidis.
Vyndaqel is a medicine which treats a disease called transthyretin amyloidosis. Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) that does not work properly. TTR is a protein that carries other substances, such as hormones, through the body.
In patients with this disease, TTR breaks up and may form fibres called amyloid. Amyloid can build up between cells in your heart (known as transthyretin amyloid cardiomyopathy or ATTR-CM) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs in your heart, it prevents your heart from working normally.
Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients whose heart has been affected (people with symptomatic cardiomyopathy).
⚠️ 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 taking Vyndaqel.
72 Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one 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 the symptoms of transthyretin amyloidosis. Vyndaqel is therefore not used for 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 inform your doctor or pharmacist if you are taking any of the following:
- non-steroidal anti-inflammatory drugs
- diuretic medicines (e.g. furosemide, bumetanide)
- anti-cancer medicines (e.g. methotrexate, imatinib)
- statins (e.g. rosuvastatin, atorvastatin)
- anti-clotting medicines (e.g. apixaban, rivaroxaban)
- anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Vyndaqel if you are pregnant or breast-feeding. If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.
Driving and using machines
Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.
Vyndaqel contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
💊 3. How to take Vyndaqel
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one Vyndaqel 61 mg (tafamidis) tablet taken once a day.
If you vomit after taking this medicine and can identify the intact Vyndaqel tablet, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel tablet, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.
Method of administration Vyndaqel is for oral use.
73 The tablet should be swallowed whole, not crushed or cut.
The tablet may be taken with or without food.
Instructions for opening the blisters Push tablet through the aluminium foil.
If you take more Vyndaqel than you should
You should not take more tablets than your doctor tells you to. If you take more tablets than you have been told to take, contact your doctor.
If you forget to take Vyndaqel
If you forget to take a dose, take your tablets as soon as you remember. If it is within 6 hours before your 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 first speaking to your doctor. As Vyndaqel works by stabilising the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilised, and your disease may progress.
If you have any further 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
Diarrhoea Rash, itching In clinical studies, the side effects in patients taking Vyndaqel were generally similar to that of patients not taking Vyndaqel. Flatulence and increase in liver function tests were reported more often in ATTR-CM patients treated with Vyndaqel.
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. How to store 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 card and on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Vyndaqel contains
The active substance is tafamidis. Each tablet contains 61 mg micronized tafamidis. The other ingredients are: microcrystalline cellulose (E 460), lactose monohydrate (E 24) [see
section 2 “Vyndaqel contains lactose monohydrate”], crospovidone (E 1202), magnesium
stearate (E 470b), calcium carbonate, isomalt, hypromellose, and medium-chain triglycerides.
What Vyndaqel looks like and contents of the pack
Vyndaqel film-coated tablets are 11 mm round white to off-white and embossed with “61” on one side.
Vyndaqel is available in two pack sizes of OPA/Al/PVC-alu blisters.
Pack sizes: a pack of 3 x 10 film-coated tablets and a pack of 9 x 10 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH Mooswaldallee 1 79108 Freiburg Im Breisgau Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11 Latvija Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775 България Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4000 Česká republika Pfizer, spol. s r.o.
Tel: +420 283 004 111 Magyarország Pfizer Kft.
Tel.: +36 1 488 37 00 Danmark Pfizer ApS Tlf.: +45 44 20 11 00 Malta Vivian Corporation Ltd.
Tel: +356 21344610 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51000 Nederland Pfizer bv Tel: +31 (0)800 63 34 636 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500 Norge Pfizer AS Tlf: +47 67 52 61 00 75 Ελλάδα Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800 Österreich Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0 España Pfizer, S.L.
Tel: +34 91 490 99 00 Polska Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00 France Pfizer Tél +33 (0)1 58 07 34 40 Portugal Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500 Hrvatska Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777 România Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616161 Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400 Ísland Icepharma hf.
Sími: +354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500 Italia Pfizer S.r.l.
Tel: +39 06 33 18 21 Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Κύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22817690 Sverige Pfizer AB Tel: +46 (0)8 550 520 00 This leaflet was last revised in <{MM/YYYY}>.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder’s local office number that is provided in this leaflet.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Vyndaqel (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/11/717).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.