Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vyndaqel

Document Subject

Generated Narrative: MedicinalProductDefinition mp895d12c7e06fa00ecf48ed16e513c5f0

identifier: http://ema.europa.eu/identifier/EU/1/11/717/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vyndaqel 20 mg soft capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-895d12c7e06fa00ecf48ed16e513c5f0

identifier: http://ema.europa.eu/identifier/EU/1/11/717/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vyndaqel

Attesters

What is in this leaflet

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

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 around your nerves (known as transthyretin amyloid polyneuropathy or ATTR-PN) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs, it prevents them from working normally. Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further progression.

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 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. 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)

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.

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 20 mg (tafamidis meglumine) 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people are listed below:

Diarrhoea

Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)

Stomach ache 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.

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 store above 25 C. 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.

What Vyndaqel contains

The active substance is tafamidis. Each capsule contains 20 mg micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.

The other ingredients are: gelatine (E 441), glycerine (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, polyvinyl acetate phthalate, propylene glycol (E 1520), carmine (E 120), brilliant blue FCF (E 133) and ammonium hydroxide (E 527). What Vyndaqel looks like and contents of the pack Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) printed with VYN 20 in red. 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 Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium Manufacturer Pfizer Service Company BV Hoge Wei 1930 Zaventem Belgium Or Millmount Healthcare Limited Block 7, City North Business Campus Stamullen K32 YDIreland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4 ,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616Latvija Pfizer Luxembourg SARL fili le Latvij Tel: +371 670 35 This leaflet was last revised in <{MM/YYYY}><{month YYYY}>. This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine 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: