BYLVAY 200 MCG Kapsułki twarde
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Treść ulotki
Bylvay 200 micrograms hard capsules, 400 micrograms hard capsules, 600 micrograms hard capsules, 1 200 micrograms hard capsules
odevixibat
Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicine (see the end of section 4 for information on how to report adverse effects).
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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Bylvay is and what it is used for
- 2. What you need to know before you take Bylvay
- 3. How to take Bylvay
- 4. Possible side effects
- 5. How to store Bylvay
- 6. Contents of the pack and other information
1. What is Bylvay and what is it used for
Bylvay contains the active substance odevixibat. Odevixibat is a medicine that increases the removal
of substances called bile acids from the body. Bile acids are components of the digestive fluid
called bile, which is produced by the liver and secreted into the intestine. Odevixibat blocks the mechanism
that normally reabsorbs them from the intestine after they have performed their function. This allows them
to exit the body in the stool.
Bylvay is used to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged
6 months or older. PFIC is a liver disease caused by the accumulation of bile acids
(cholestasis) that worsens over time and is often accompanied by severe itching.
2. What you need to know before taking Bylvay
Do not take Bylvay
- if you are allergic to odevixibat or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bylvay if:
- you have been diagnosed with complete absence or lack of function of the bile salt efflux pump protein;
- you have severely reduced liver function;
- you have reduced gastric or intestinal motility, or reduced circulation of bile acids between liver, bile and small intestine due to taking medicines, surgery or illnesses other than PFIC. These conditions may reduce the effect of odevixibat.
If you experience diarrhoea while taking Bylvay, contact your doctor. Patients who experience
diarrhoea are advised to drink enough fluids to prevent dehydration.
During the intake of Bylvay, an increase in liver enzyme levels may be observed in liver
function tests. Before starting Bylvay, your doctor will measure liver function
to verify correct liver function. Your doctor will perform regular checks to
monitor liver function.
Before and during treatment, your doctor may also check the levels of vitamins A, D and E in
your blood and your INR (international normalised ratio, which measures the risk of bleeding).
Children
Bylvay is not recommended for children under 6 months of age, as it is not known whether the
medicine is safe and effective in this age group.
Other medicines and Bylvay
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Treatment with odevixibat may affect the absorption of fat-soluble vitamins, such as
vitamin A, D and E, and some medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Bylvay is not recommended during pregnancy and in women of childbearing potential who are not using
contraception.
It is not known whether odevixibat can pass into breast milk and have effects on the baby. Your doctor
will help you decide whether to stop breastfeeding or avoid treatment with Bylvay, considering the
benefit of breastfeeding for the baby and taking Bylvay for the mother.
Driving and using machines
Bylvay does not or negligibly alters the ability to drive and operate machines.
3. How to take Bylvay
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Treatment must be started and supervised by a doctor experienced in the management of progressive
liver disease with reduced bile flow.
The dose of Bylvay depends on your weight. Your doctor will determine the correct number and dosage of capsules to
take.
The recommended dose is
- 40 micrograms of odevixibat per kilogram of body weight once a day
- If the medicine is not sufficiently effective after 3 months, your doctor may increase the dose to 120 micrograms of odevixibat per kilogram of body weight (up to a maximum of 7,200 micrograms once a day).
For adults, no difference in dose is recommended.
How to use
Take the capsules once a day in the morning with or without food.
All capsules can be swallowed whole with a glass of water or opened and sprinkled on
food or dispersed in a suitable liquid for age (e.g., breast milk, formula or water)
The larger 200 and 600 microgram capsules are intended to be opened and sprinkled on food, or
dispersed in a suitable liquid for age, but can be swallowed whole.
The smaller 400 and 1,200 microgram capsules are intended to be swallowed whole, but can
be opened and sprinkled on food or dispersed in a suitable liquid for age.
Detailed instructions for opening the capsules and sprinkling the contents on food or in a liquid are
If the medicine does not improve your condition after 6 months of continuous daily treatment, your
doctor will advise you on alternative treatment.
If you take more Bylvay than you should
Inform your doctor if you think you have taken an excessive amount of Bylvay.
Possible symptoms of overdose are diarrhea, stomach and intestinal problems.
If you forget to take Bylvay
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.
If you stop taking Bylvay
Treatment with Bylvay should not be stopped without first consulting your doctor.
If you have any doubts about 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.
Side effects can occur with the following frequency:
Very common(may affect more than 1 in 10 people)
- diarrhoea including diarrhoea with blood in the stools, soft stools
- vomiting
- abdominal pain (stomach ache)
Common(may affect up to 1 in 10 people)
- enlarged liver
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store Bylvay
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 package and bottle after
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light. Do not store at a
temperature higher than 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Bylvay contains
- The active substance is odevixibat. Each Bylvay hard capsule containing 200 micrograms contains 200 micrograms of odevixibat (as sesquihydrate). Each Bylvay hard capsule containing 400 micrograms contains 400 micrograms of odevixibat (as sesquihydrate). Each Bylvay hard capsule containing 600 micrograms contains 600 micrograms of odevixibat (as sesquihydrate). Each Bylvay hard capsule containing 1 200 micrograms contains 1 200 micrograms of odevixibat (as sesquihydrate).
The other ingredients are:
- Capsule contents Microcrystalline cellulose Hypromellose
Capsule shell
Bylvay 200 micrograms and 600 micrograms hard capsules
Hypromellose
Titanium dioxide (E171)
Yellow iron oxide (E172)
Bylvay 400 micrograms and 1 200 micrograms hard capsules
Hypromellose
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)
Printing ink
Shellac
Propylene glycol
Black iron oxide (E172)
Description of Bylvay and contents of the pack
Bylvay 200 micrograms hard capsules:
Size 0 (21.7 mm × 7.64 mm) capsules with an opaque ivory cap and an opaque white body, with the inscription
“A200” in black ink.
Bylvay 400 micrograms hard capsules:
Size 3 (15.9 mm × 5.82 mm) capsules with an opaque orange cap and an opaque white body, with the
inscription “A400” in black ink.
Bylvay 600 micrograms hard capsules:
Size 0 (21.7 mm × 7.64 mm) capsules with an opaque ivory cap and body, with the inscription “A600” in
black ink.
Bylvay 1 200 micrograms hard capsules:
Size 3 (15.9 mm × 5.82 mm) capsules with an opaque orange cap and body, with the inscription “A1200”
in black ink.
The Bylvay hard capsules are packaged in a plastic bottle with a tamper-evident and child-resistant closure. Pack size: 30 hard capsules
Marketing Authorisation Holder
Ipsen Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
France
Manufacturer
Almac Pharma Services Limited
Seagoe Industrial Estate
Portadown, Craigavon
County Armagh
BT63 5UA
United Kingdom (Northern Ireland)
For further information on this medicine, contact the local representative of the marketing authorisation
holder:
België/Belgique/Belgien/Luxembourg/
Luxemburg
Ipsen NV
België/Belgique/Belgien
Tél/Tel: +32 9 243 96 00
Italia
Ipsen SpA
Tel: + 39 02 39 22 41
България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480
Latvija
Ipsen Pharma representative office
Tel: + 371 67622233
Česká republika
Ipsen Pharma s.r.o
Tel: +420 242 481 821
Lietuva
Ipsen Pharma SAS Lietuvos filialas
Tel: +370 700 33305
Danmark, Norge, Suomi/Finland, Sverige,
Ísland
Institut Produits Synthèse (IPSEN) AB
Sverige/Ruotsi/Svíþjóð
Tlf/Puh/Tel/Sími: +46 8 451 60 00
Magyarország
IPSEN Pharma Hungary Kft.
Tel.: + 36 1 555 5930
Deutschland, Österreich
Ipsen Pharma GmbH
Deutschland
Tel: +49 89 2620 432 89
Nederland
Ipsen Farmaceutica B.V.Tel: +31 (0) 23 554 1600
Eesti
Centralpharma Communications OÜ
Tel: +372 60 15 540
Polska
Ipsen Poland Sp. z o.o.
Tel.: + 48 22 653 68 00
Ελλάδα, Κύπρος, Malta
Ipsen Μονοπρόσωπη EΠΕ
Ελλάδα
Τηλ: +30 210 984 3324
Portugal
Ipsen Portugal - Produtos Farmacêuticos S.A.
Tel: + 351 21 412 3550
España
Ipsen Pharma, S.A.U.
Tel: +34 936 858 100
România
Ipsen Pharma România SRL
Tel: + 40 21 231 27 20
France
Ipsen Pharma
Tél: +33 1 58 33 50 00
Slovenija
Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
Slovenská republika
Ipsen Pharma, organizačná zložka
Tel: + 420 242 481 821
Ireland, United Kingdom (Northern Ireland)
Ipsen Pharmaceuticals Limited
Tel: +44 (0)1753 62 77 77
An authorisation has been granted for this medicinal product in “exceptional circumstances”. This means that
due to the rarity of the disease it has not been possible to obtain complete information on this medicine.
The European Medicines Agency will review any new information annually on this
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website,
http://www.ema.europa.eu. Also, links to other websites on rare diseases and related therapeutic treatments
are provided.
Instructions
Instructions for opening the capsules and sprinkling the contents on food:
Step 1. Place a small amount of soft food in a bowl (2 tablespoons/30 mL of yogurt,
applesauce, banana puree or carrot puree, chocolate pudding, rice pudding or oatmeal). The
food should be at room temperature or cooler.
 | m Step 2:
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 | e Step 3: d
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i a I t a l | i Step 4:
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Instructions for opening the capsules and pouring the contents into age-appropriate liquid:
Do not administer with a baby bottle or sippy cup, as the granules will not pass
through the opening. The granules do not dissolve in the liquid.
Contact your pharmacy if you do not have a suitable oral syringe at home.
 | m Step 1:
|
l Add 1 teaspoon (5 mL) of age-appropriate liquid (e.g. breast milk, infant formula or water). d
| |
I t a | n Step 2: a
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| i a | Step 3:
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A g e n z | Step 4:
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- If there is still some liquid/granule mixture in the measuring cup, repeat steps 3 and 4 until the entire dose has been administered. Administer the entire dose immediately after mixing. Do not store the liquid/granule mixture for later use.
- After administering the dose, give breast milk, infant formula or another age-appropriate liquid.
- Dispose of all empty capsule shells.
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 200 MCG
- Kod ATCA05AX05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BYLVAYPostać farmaceutyczna: Film-coated tablet, 80 mgSubstancja czynna: elafibranorProducent: IPSEN PHARMAWymaga receptyPostać farmaceutyczna: Oral solution, 9.5 mg / mLSubstancja czynna: maralixibat chlorideProducent: Mirum Pharmaceuticals International B.V.Wymaga receptyPostać farmaceutyczna: Hard capsule, 10 mgSubstancja czynna: Other drugs for bile therapyProducent: GILEAD SCIENCES IRELAND UCWymaga recepty
Odpowiedniki BYLVAY w innych krajach
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BYLVAY wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w BYLVAY jest odevixibat. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BYLVAY jest produkowany przez IPSEN PHARMA. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie BYLVAY jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić BYLVAY w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (odevixibat) to m.in. IQIRVO, LIVMARLI, LYVDELTSI. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
