VYNDACEL

Package leaflet: Information for the user

Vyndaqel 20 mg soft capsules

tafamidis meglumine

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vyndaqel is and what it is used for

Vyndaqel contains the active substance tafamidis.
Vyndaqel is a medicine indicated for the treatment of a disease known as transthyretin amyloidosis. Transthyretin amyloidosis is caused by malfunctioning of a protein called transthyretin (TTR). TTR is a protein that transports substances within the body, including hormones.
In patients affected by this disease, the TTR protein dissociates to form fibres known as amyloids. These amyloids deposit around nerves (causing a condition known as transthyretin amyloid polyneuropathy or ATTR-PN) and in other parts of the body, leading to the symptoms of this disease and impairing normal function.
Vyndaqel prevents the dissociation of TTR proteins, thereby preventing the formation of amyloids. This medicine is used to treat adult patients whose nerves have been affected by the disease (patients with symptomatic polyneuropathy) in order to delay further progression of the disease.

2. What you should know before taking Vyndaqel

Do not take Vyndaqel
If you are allergic to tafamidis meglumine or to 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 must use effective contraceptive methods during treatment with Vyndaqel and for one month after stopping treatment. There are no data on the use of Vyndaqel in pregnant women.

Children and adolescents
Children and adolescents do not present symptoms of transthyretin amyloidosis. Therefore,
Vyndaqel must not be used in children and adolescents.

Other medicines and Vyndaqel
Inform 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 medicines:

• non-steroidal anti-inflammatory drugs (NSAIDs)
• diuretics (e.g. furosemide, bumetanide)
• anticancer 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, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

• Do not take Vyndaqel during pregnancy or while breastfeeding.
• If you are of childbearing potential, you must use effective contraception during treatment and for one month after stopping treatment.

Driving and using machines
Vyndaqel is considered to have no or negligible influence on the ability to drive and use
machinery.

Vyndaqel contains sorbitol
This medicine contains no more than 44 mg of sorbitol per capsule. Sorbitol is a source of
fructose.

3. How to take Vyndaqel

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule (20 mg of tafamidis meglumine) of Vyndaqel once daily.
If vomiting occurs after administration and an intact Vyndaqel capsule is found, an additional dose of Vyndaqel should be taken the same day; if the capsule is not found,
no additional dose is necessary and the next dose of Vyndaqel can be taken the following day as scheduled.
Method of administration
Vyndaqel is for oral use.
The soft capsules must be swallowed whole, without chewing or breaking them.
The capsule may be taken with or without food.
Instructions for opening the blister packs

• Detach a single blister from the blister sheet along the perforated line.
• Push the capsule through the aluminium foil.

If you take more Vyndaqel than you should
Do not take more capsules than prescribed by your doctor. If you take more capsules than you should,
inform your doctor.
If you forget to take Vyndaqel
If you forget to take a dose, take the capsule as soon as you remember. If
less than 6 hours remain before the next dose, do not take the missed dose, but 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 treatment with Vyndaqel without first informing your doctor. Since Vyndaqel
stabilizes the TTR protein, if you stop treatment with Vyndaqel, the medicine will no longer stabilize the protein and the disease may progress.
If you have any questions about the use of Vyndaqel, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following very common side effects may affect more than 1 in 10 people:

• Diarrhoea
• Urinary tract infections (symptoms include: pain or burning sensation when urinating, or frequent need to urinate)
• Stomach ache or abdominal pain

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vyndaqel

Keep Vyndaqel out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components 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), ethyl alcohol, isopropyl alcohol, phthalate polyvinyl acetate, propylene glycol (E 1520), carmine (E 120), brilliant blue FCF (E 133) and ammonium hydroxide (E 527).

Description of the appearance of Vyndaqel and contents of the pack
Vyndaqel soft capsules are yellow, opaque, oblong in shape (approximately 21 mm),
marked with the inscription «VYN 20» in red. Vyndaqel is available in two blister pack
configurations in single-dose perforated PVC/PA/Alu/PVC-Alu/PET/paper: one pack containing 30x1
soft capsules and a multiple pack containing 90 soft capsules comprising 3 boxes, each
containing 30x1 soft capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder Manufacturer
Pfizer Europe MA EEIG Pfizer Service Company BV
Boulevard de la Plaine 17 Hoge Wei 10
1050 Brussels 1930 Zaventem
Belgium 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11
България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Tel.: +359 2 970 4333 Tel.: +36 1 488 37 00
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: +356 21344610
Danmark Nederland
Pfizer ApS Pfizer bv
Tlf.: +45 44 20 11 00 Tel: +31 (0)800 63 34 636
Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00
Tηl: +30 210 6785800
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500
France România
Pfizer Pfizer Romania S.R.L.
Tél +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: + 385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL, organizačná zložka
Tel: +1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161
Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Tηl: +357 22817690
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

This medicinal product has been authorised under "exceptional circumstances". This means that,
due to the rarity of the disease, it has not been possible to obtain complete information about this
medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually,
and this patient information leaflet will be updated as necessary.
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.
If this patient information leaflet is difficult to read, or if you would prefer it in a different format, please contact the local office of the Marketing Authorisation Holder listed in this leaflet.

Package leaflet: information for the user

Vyndaqel 61 mg soft capsules

tafamidis

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vyndaqel is and what it is used for

Vyndaqel contains the active substance tafamidis.
Vyndaqel is a medicine indicated for the treatment of a condition known as transthyretin amyloidosis. Transthyretin amyloidosis is caused by malfunction of a protein called transthyretin (TTR). TTR is a protein that transports substances within the body, including hormones.
In patients affected by this disease, the TTR protein dissociates and forms fibres known as amyloids. These amyloids deposit between the cells of the heart (transthyretin amyloid cardiomyopathy or ATTR-CM) and in other parts of the body, leading to the symptoms of this disease.
When this occurs in the heart, the heart is unable to function normally.
Vyndaqel works by preventing the dissociation of TTR proteins, thereby inhibiting the formation of amyloids. This medicine is used for the treatment of adult patients whose heart has been affected by the disease (patients with symptomatic cardiomyopathy).

2. What you need to know before taking Vyndaqel

Do not take Vyndaqel
If you are allergic to tafamidis or to 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 must use effective contraceptive measures during treatment with Vyndaqel and 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 present symptoms of transthyretin amyloidosis. Therefore,
Vyndaqel must not be used in children and adolescents.
Other medicines and Vyndaqel
Inform 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 medicines:

• non-steroidal anti-inflammatory drugs
• diuretics (e.g. furosemide, bumetanide)
• anticancer medicines (e.g. methotrexate, imatinib)
• statins (e.g. rosuvastatin)
• antiviral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudina, zidovudina, zalcitabina)

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

• Do not take Vyndaqel during pregnancy or while breastfeeding.
• If you are of childbearing potential, you must use an effective method of contraception during treatment and for one month after stopping treatment.

Driving and using machines
Vyndaqel is considered to have no effect or negligible effect on the ability to drive and use
machinery.
Vyndaqel contains sorbitol
This medicine contains no more than 44 mg of sorbitol per capsule. Sorbitol is a source of
fructose.

3. How to take Vyndaqel

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one capsule (61 mg of tafamidis) of Vyndaqel once daily.

If vomiting occurs after administration and an intact Vyndaqel capsule is identified, an additional dose of Vyndaqel should be taken on the same day. If the capsule is not identified, no additional dose is required, and the next scheduled dose of Vyndaqel can be taken the following day as planned.

Method of administration

Vyndaqel is for oral use.

The soft capsules must be swallowed whole and must not be chewed or broken.

The capsule may be taken with or without food.

Instructions for opening the blister packs

• Detach a single blister from the blister card along the perforated line.
• Push the capsule through the aluminium foil.

If you take more Vyndaqel than you should

Do not take more capsules than prescribed by your doctor. If you take more capsules than instructed, inform your doctor.

If you forget to take Vyndaqel

If you forget to take a dose, take the capsule as soon as you remember. If less than 6 hours remain before the next scheduled dose, do not take the missed dose; instead, 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 treatment with Vyndaqel without first informing your doctor. Since Vyndaqel stabilizes the TTR protein, if you stop taking Vyndaqel, the medicine will no longer stabilize the protein and the disease may progress.

If you have any questions about the use of Vyndaqel, consult 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

• Diarrhea
• Rash, itching

In clinical studies, side effects in patients treated with Vyndaqel were generally similar to those observed in patients not treated with Vyndaqel. Flatulence and increased liver function tests were reported more frequently in patients with ATTR-CM treated with Vyndaqel.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vyndaqel

Keep Vyndaqel out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister card or carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vyndaqel contains

• The active substance is tafamidis. Each capsule contains 61 mg of micronized tafamidis.
• The other components are: gelatin (E 441), glycerol (E 422), sorbitol (E 420) [see section 2 “Vyndaqel contains sorbitol”], mannitol (E 421), sorbitan, iron oxide red (E 172), purified water, macrogol 400 (E 1521), polysorbate 20 (E 432), povidone (K 90 value), butylated hydroxytoluene (E 321), ethanol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171) and ammonium hydroxide (E 527).

Description of the appearance of Vyndaqel and contents of the pack
Vyndaqel soft capsules are opaque, reddish-brown, oblong-shaped (approximately 21 mm) and marked with the inscription “VYN 61” in white. Vyndaqel is available in two blister pack presentations in single-dose perforated PVC/PA/Alu/PVC-Alu/PET/paper: one pack containing 30x1 soft capsules and a multipack containing 90 soft capsules comprising 3 boxes, each containing 30x1 soft capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder
Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder listed in this leaflet:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

България
Pfizer Luxembourg SARL, Branch Bulgaria
Tel: +359 2 970 4333

Česká republika
Pfizer s.r.o.
Tel: +420 283 004 111

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Eesti
Pfizer Luxembourg SARL, Eesti filiaal
Tel: +372 666 7500

Ελλάδα
Pfizer Ελλάς A.E.
Tel: +30 210 6785800

España
Pfizer, S.L.
Tel: +34 91 490 99 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Ísland
Icepharma hf.
Sími: +354 540 8000

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Tel: +357 22 817690

Latvija
Pfizer Luxembourg SARL, filiāle Latvijā
Tel: +371 670 35 775

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

Magyarország
Pfizer Kft.
Tel: +36 1 488 37 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Polska
Pfizer Polska Sp. z o.o.
Tel: +48 22 335 61 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.
If this patient information leaflet is difficult to read or if you would prefer it in a different format, please contact the local office of the Marketing Authorization Holder listed in this leaflet.