Patient leaflet - Vyndaqel 61 mg soft capsules
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.
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.
What Vyndaqel looks like and contents of the pack
Vyndaqel soft capsules are reddish brown, opaque, oblong (approximately 21 mm) printed with “VYN 61” in white. Vyndaqel is available in two pack sizes of PVC/PA/alu/PVC-alu perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau Germany
For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in 04/2026.
Ref: VY 11_0
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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 sorbitol
This medicine contains no more than 44 mg 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. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one Vyndaqel 61 mg (tafamidis) capsule taken once a day.
If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, 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.
The soft capsule should be swallowed whole, not crushed or cut. The capsule may be taken with or without food.
Instructions for opening the blisters
- Tear off one individual blister from the blister card along the perforated line.
- Push capsule through the aluminium foil.
If you take more Vyndaqel than you should
You should not take more capsules than your doctor tells you to. If you take more capsules 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 capsules 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 capsule contains 61 mg micronized tafamidis.
The other ingredients are: gelatine (E 441), glycerine (E 422), sorbitol (E 420)
[see section 2 “Vyndaqel contains sorbitol”], mannitol (E 421), sorbitan, red iron oxide (E 172), purified water, macrogol 400 (E 1521), polysorbate 20 (E 432), povidone (K-value 90), butylated hydroxytoluene (E321), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171), and ammonium hydroxide (E 527).
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