20 mg soft capsules
tafamidis meglumine
What Vyndaqel is and what it is used for
Vyndaqel contains the active substance tafamidis.
Vyndaqel is a medicine for the treatment of the disease transthyretin amyloidosis. Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) not working properly. TTR is a protein that transports other substances, e.g. hormone er, through the body.
In patients who have this disease, TTR breaks down and can form fibers called amyloid. Amyloid can build up around your nerves (known as transthyretin amyloidosis with polyneuropathy or ATTR-PN) and elsewhere in the body.
The amyloid deposits cause the symptoms of this disease. When that happens, they prevent them from functioning normally.
Vyndaqel can prevent TTR from breaking up and forming amyloid. The medicine is used to treat adult patients who have this disease and whose nerves have been affected (people with symptomatic polyneuropathy ) to delay progression.
What you need to know before you use Vyndaqel
Do not use Vyndaqel
- if you are allergic to tafamidis meglumine 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 of childbearing potential should use contraception while taking Vyndaqel and should continue to do so for one month after treatment with Vyndaqel has stopped. There are no data on the use of Vyndaqel in pregnant women.
Children and young people
Children and adolescents have no symptoms of transthyretin amyloidosis. Vyndaqel is therefore 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 must inform your doctor or pharmacist if you are taking any of the following:
- non-steroidal anti-inflammatory drugs
- diuretics (eg, furosemide , bumetanide)
- anticancer drugs (eg, methotrexate, imatinib)
- statins (eg rosuvastatin)
- antiviral medicines (eg 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 using this medicine.
- You should not take Vyndaqel if you are pregnant. or breastfeeding.
- If you can get pregnant (are fertile ), you must use contraception during treatment and for one month after treatment ends.
Driving ability and use of machinery
Vyndaqel is presumed to have no or negligible effect on the ability to drive and use machines.
Vyndaqel contains sorbitol
This medicine does not contain more than 44 mg of sorbitol per capsule. Sorbitol is a source of fructose.
How to use Vyndaqel
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one capsule of Vyndaqel 20 mg tafamidis meglumine once daily.
If you vomit after taking the medicine and you can see the intact Vyndaqel capsule, take another dose of Vyndaqel the same day. If you do not see a Vyndaqel pill, no new dose of Vyndaqel is needed, but you can continue to take Vyndaqel the next day as usual.
Mode of administration
Vyndaqel is for oral use.
The soft capsule should be swallowed whole and not crushed or split.
The capsule can be taken with or without food.
Instructions for opening the blister
- Pull off an individual blister from the blister card along the perforated line.
- Push the capsule through the aluminum foil.
If you use too much Vyndaqel
Do not take more capsules than the doctor prescribes. If you have taken more capsules than the doctor has prescribed, contact your doctor.
If you forget to use Vyndaqel
If you have forgotten to take a dose, take your capsules 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 missed dose.
If you stop using Vyndaqel
Do not stop taking Vyndaqel without first talking to your doctor. Vyndaqel works by stabilizing the protein et TTR. If you stop taking Vyndaqel, protein et is no longer stabilized and the disease may worsen.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 users:
- Diarrhea
- Urinary tract infection (with symptoms such as pain or burning sensation when urinating or needing to urinate frequently)
- Vaginal infection in women
- Stomach or abdominal pain
Talk to your doctor, pharmacist, or nurse if you get side effects. This also applies to any side effects that are not mentioned in this information.
How to store Vyndaqel
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the blister card and carton. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC. Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tafamidis. Each soft capsule contains 20 mg micronized tafamidis meglumine corresponding to 12.2 mg tafamidis.
- Other ingredients are gelatin (E 441), glycerin (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 package sizes of the medicine
Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) capsules imprinted, “VYN20” in red. Vyndaqel is supplied in two pack sizes of PVC/PA/Alu/PVC-alu perforated unit dose blisters: a pack of 30 x 1 soft capsule and in a multipack of 90 soft capsules containing 3 packs, each containing 30 x 1 soft capsule.
Not all pack sizes may be marketed.
| Marketing Authorisation Holder | Manufacturer |
|---|---|
| Pfizer Europe MA EEIGBoulevard de la Plaine 171050 BrusselsBelgium | Pfizer Service Company BVHoge Wei 101930 Zaventem Belgium or Millmount Healthcare LimitedBlock-7, City North Business CampusThe stem. Meath Ireland |
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/Belgien Luxembourg/LuxemburgPfizer NV/SATel/Tel: + 32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 3705 2514000 |
| BulgariaPfizer Luxembourg САРЛ, Клон БулгарияTel.: + 359 2 970 4333 | MagyarországPfizer Kft.Phone: + 36 1 488 3700 |
| Czech RepublicPfizer, coil. s iPhone: +420 283 004 111 | MaltaVivian Corporation Ltd.Phone: + 356 21344610 |
| DenmarkPfizer ApSTel: + 45 44 20 11 00 | The NetherlandsPfizer by phone: + 31 (0)10 406 43 01 |
| DeutschlandPfizer Pharma GmbHPhone: + 49 (0)30 550055-51000 | NorwayPfizer iPhone: + 47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branch phone: + 372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: + 43 (0)1 521 15-0 |
| GreecePFIZER ΕΛΛΑΣ Α.Ε.,Tel: + 30 210 67 85 800 | PolishPfizer Polska Sp. z o. o.Tel.: + 48 22 335 61 00 |
| SpainPfizer, SLPhone: + 34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: + 351 21 423 5500 |
| FrancePfizerTel: + 33 (0)1 58 07 34 40 | RomaniaPfizer Romania SRLPhone: + 40 (0)21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: + 385 1 3908 777 | SlovenijaPfizer Luxembourg SARLPfizer, branch of the field pharmaceuticals activities, LjubljanaPhone: + 386 (0)1 52 11 400 |
| IrelandPfizer Healthcare IrelandPhone: + 353 1800 633 363 (toll free)Phone: + 44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL, organizačná zložkaPhone: + 421 2 3355 5500 |
| IcelandIcepharma hf.Telephone: + 354 540 8000 | Finland/FinlandPfizer OyPhone/Tel: + 358 (0)9 430 040 |
| ItalyPfizer SrlPhone: + 39 06 33 18 21 | SwedenPfizer ABPhone: + 46 (0)8 550 520 00 |
| CyprusPFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Τηλ: + 357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: + 44 (0)1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaPhone: + 371 670 35 775 |