Vyndaqel
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-09-2023
Charakterystyka produktu
(SPC)
22-09-2023
Sprawozdanie z oceny publicznego
(PAR)
02-08-2016
Składnik aktywny:
tafamidis
Dostępny od:
Pfizer Europe MA EEIG
Kod ATC:
N07XX08
INN (International Nazwa):
tafamidis
Grupa terapeutyczna:
Other nervous system drugs
Dziedzina terapeutyczna:
Amyloidosis
Wskazania:
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Podsumowanie produktu:
Revision: 27
Status autoryzacji:
Authorised
Data autoryzacji:
2011-11-16
Ulotka dla pacjenta
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
VYNDAQEL 20 MG SOFT CAPSULES
tafamidis meglumine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
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
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 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
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Health care professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Vyndaqel 20 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 mg of micronized tafamidis meglumine
equivalent to 12.2 mg tafamidis.
Excipient with known effect
Each soft capsule contains no more than 44 mg of sorbitol (E 420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with
“VYN 20” in red.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vyndaqel is indicated for the treatment of transthyretin amyloidosis
in adult patients with stage 1
symptomatic polyneuropathy to delay peripheral neurologic impairment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
knowledgeable in the management
of patients with transthyretin amyloid polyneuropathy (ATTR-PN).
Posology
The recommended dose of tafamidis meglumine is 20 mg orally once
daily.
Tafamidis and tafamidis meglumine are not interchangeable on a per mg
basis.
If vomiting occurs after dosing, and the intact Vyndaqel capsule is
identified, then an additional dose
of Vyndaqel should be administered if possible. If no capsule is
identified, then no additional dose is
necessary, with resumption of dosing the next day as usual.
Special populations
_Elderly_
No dosage adjustment is required for elderly patients (≥ 65 years)
(see section 5.2).
3
_Hepatic and renal impairment_
No dosage adjustment is required for patients with renal or mild and
moderate hepatic impairment.
Limited data are available in patients with severe renal impairment
(creatinine clearance less than or
equal to 30 mL/min). Tafamidis meglumine has not been studied
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