Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bylvay

Document Subject

Generated Narrative: MedicinalProductDefinition mp095ad71337cf86d5fe21eb3ee2e24f22

identifier: http://ema.europa.eu/identifier/EU/1/21/1566/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bylvay 200 micrograms hard 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-095ad71337cf86d5fe21eb3ee2e24f22

identifier: http://ema.europa.eu/identifier/EU/1/21/1566/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - bylvay

Attesters

What is in 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

Bylvay contains the active substance odevixibat. Odevixibat is a medicine which 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 intestines. Odevixibat blocks the mechanism that normally reabsorbs them from the intestines after they have done their job. This allows them to pass out of 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 build-up of bile acids (cholestasis) that gets worse over time and is often accompanied with severe itching.

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 a complete absence or lack of function of bile salt export pump protein
• severely reduced liver function
• reduced stomach or bowel motility, or reduced circulation of bile acids between liver, bile and small intestine due to medicines, surgical procedures or diseases other than PFIC since these may reduce the effect of odevixibat

Talk to your doctor if you develop diarrhoea while taking Bylvay. Drinking sufficient liquid is recommended in patients with diarrhoea to prevent dehydration.

Increased levels in liver function tests can occur in some patients receiving Bylvay. Assessment of liver function is recommended for all patients prior to Bylvay treatment. Your doctor may recommend more frequent monitoring if you have elevated liver function test results.
Your doctor may recommend assessment of Vitamin A, D and E blood levels and the blood clotting value called INR prior to and during Bylvay treatment.

Children

Bylvay is not recommended for babies under 6 months because it is not known if the medicine is safe and effective in this age group.

Other medicines and Bylvay

Tell your doctor or pharmacist if you are using, have recently used or might use 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Bylvay is not recommended during pregnancy and in women of childbearing potential not using contraception.

It is not known if odevixibat can pass into breast milk and affect the baby. Your doctor will help you to decide whether to stop breast-feeding or avoid Bylvay treatment, considering the benefit of breast- feeding to the baby and Bylvay to the mother.

Driving and using machines

Bylvay has no or negligible influence on the ability to drive or capacity to use machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 is based on your weight. Your doctor will work out the right number and strength of capsules for you to take.

The recommended dose is

• 40 micrograms odevixibat per kilogram body weight once daily
• If the medicine is not working well enough after 3 months, your doctor may increase the dose to 120 micrograms odevixibat per kilogram body weight (up to a maximum of 7 200 micrograms once daily).

No dose differences are recommended for adults.

Method of use
Take the capsules once daily in the morning with or without food.

All capsules can be either swallowed whole with a glass of water or opened and sprinkled on food.

The larger 200 and 600 micrograms capsules are intended to be opened and sprinkled on food but may be swallowed whole. The smaller 400 micrograms and 1 200 micrograms capsules are intended to be swallowed whole but may be opened and sprinkled on food.

Instructions to open capsules and sprinkle the contents on food:

• Place a small amount of soft food into a bowl (2 tablespoons/30 mL of yoghurt, apple sauce, banana or carrot puree, chocolate pudding, rice pudding or oatmeal porridge). Food should be at or below room temperature.

  Hold the capsule horizontally at both ends, twist in opposite directions.

  Pull apart to empty the contents into the bowl of soft food.

  Gently tap the capsule to ensure that all pellets come out.

  Repeat the previous step if the dose requires more than one capsule.

  Gently mix the contents of the capsule into the soft food.

• Take the entire dose immediately after mixing. Do not store the mixture for future use.

• Drink a glass of water following the dose.

• Dispose of the empty capsule shells.

If the medicine does not improve your condition after 6 months of continuous daily treatment, your doctor will recommend an alternative treatment.

If you take more Bylvay than you should

Tell your doctor if you think you have taken too much Bylvay.

Possible overdose symptoms are diarrhoea, stomach and bowel problems.

If you forget to take Bylvay

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Bylvay

Do not stop taking Bylvay without first discussing with your doctor.

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.

Side effects may occur with the following frequency: common (may affect up to 1 in 10 people)

• diarrhoea, including diarrhoea with bloody stool, soft stools
• abdominal (belly) pain
• enlarged liver

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 carton and bottle after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from light. 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 Bylvay contains

• The active substance is odevixibat. Each Bylvay 200 micrograms hard capsule contains 200 micrograms odevixibat (as sesquihydrate). Each Bylvay 400 micrograms hard capsule contains 400 micrograms odevixibat (as sesquihydrate). Each Bylvay 600 micrograms hard capsule contains 600 micrograms odevixibat (as sesquihydrate). Each Bylvay 1 200 micrograms hard capsule contains 1 200 micrograms odevixibat (as sesquihydrate).

• Other ingredients are:

Capsule content

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)

What Bylvay looks like and contents of the pack

Bylvay 200 micrograms hard capsules: Size 0 capsules (21.7 mm 7.64 mm) with ivory opaque cap and white opaque body; imprinted A200 with black ink.

Bylvay 400 micrograms hard capsules: Size 3 capsules (15.9 mm 5.82 mm) with orange opaque cap and white opaque body; imprinted A400 with black ink.

Bylvay 600 micrograms hard capsules: Size 0 capsules (21.7 mm 7.64 mm) with ivory opaque cap and body; imprinted A600 with black ink.

Bylvay 1 200 micrograms hard capsules: Size 3 capsules (15.9 mm 5.82 mm) with orange opaque cap and body; imprinted A1200 with black ink.

Bylvay hard capsules are packed in a plastic bottle with a tamper evident, child resistant polypropylene 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien/Luxembourg/ Luxemburg Ipsen NV Belgi /Belgique/Belgien T l/Tel: +32 9 243 96 Italia Ipsen SpA Tel: + 39 02 39 22
Swixx Biopharma EOOD Te .: +359 (0)2 4942 Latvija Ipsen Pharma representative office Tel: + 371 67622 esk republika Ipsen Pharma s.r.o
Tel: +420 242 481 Lietuva Ipsen Pharma SAS Lietuvos filialas Tel: +370 700 33Danmark, Norge, Suomi/Finland, Sverige, sland Institut Produits Synth se (IPSEN) AB Sverige/Ruotsi/Sv j
Tlf/Puh/Tel/S mi: +46 8 451 60 Magyarorsz g IPSEN Pharma Hungary Kft. Tel.: + 36 1 555 5Deutschland, sterreich Ipsen Pharma GmbH Deutschland Tel: +49 89 2620 432 Nederland Ipsen Farmaceutica B.V.Tel: +31 (0) 23 554 1Eesti Centralpharma Communications O
Tel: +372 60 15 Polska Ipsen Poland Sp. z o.o. Tel.: + 48 22 653 68 , , Malta Ipsen E

: +30 210 984 3Portugal Ipsen Portugal - Produtos Farmac uticos S.A. Tel: + 351 21 412 3Espa a Ipsen Pharma, S.A.U. Tel: +34 936 858 Rom nia Ipsen Pharma Rom nia SRL Tel: + 40 21 231 27 France Ipsen Pharma T l : +33 (0)1 58 33 50 Slovenija Swixx Biopharma d.o.o. Tel: + 386 1 2355 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Slovensk republika Ipsen Pharma, organiza n zlo ka Tel: + 420 242 481 Ireland, United Kingdom (Northern Ireland) Ipsen Pharmaceuticals Limited Tel: +44 (0)1753 62 77 This leaflet was last revised in

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: