Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - orladeyo

Document Subject

Generated Narrative: MedicinalProductDefinition mpe904990c0daca9f90faf79e88bc809b4

identifier: http://ema.europa.eu/identifier/EU/1/21/1544/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Orladeyo 150 mg 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-e904990c0daca9f90faf79e88bc809b4

identifier: http://ema.europa.eu/identifier/EU/1/21/1544/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - orladeyo

Attesters

What is in this leaflet

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

Orladeyo is a medicine that contains the active substance berotralstat. It is used to prevent angioedema attacks in adults, and adolescents aged from 12 years with hereditary angioedema.

What hereditary angioedema is

Hereditary angioedema is a condition that often runs in families. It can limit your daily activity by causing attacks of swelling and pain in different parts of your body including:

• hands and feet
• face, eyelids, lips or tongue
• voice-box (larynx), which may make breathing difficult
• genitals
• stomach and intestines

How Orladeyo works

In hereditary angioedema your blood does not have enough of a protein called C1 inhibitor, or the protein does not work properly. This leads to too much of the enzyme plasma kallikrein, which in turn increases the levels of bradykinin in your bloodstream. Too much bradykinin leads to symptoms of hereditary angioedema. Berotralstat, the active substance in Orladeyo, blocks the activity of plasma kallikrein and so reduces bradykinin. This prevents the swelling and pain that hereditary angioedema can cause.

Do not take Orladeyo

• if you are allergic to berotralstat or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor or pharmacist before taking Orladeyo if you:

• have moderate or severely reduced liver function which can increase blood levels of berotralstat
• have severely reduced kidney function
• are at risk for a certain heartbeat abnormality, known as QT prolongation

Treat a hereditary angioedema attack with your regular rescue medicine without taking additional doses of Orladeyo. It is not known if Orladeyo works for immediate treatment of attacks of hereditary angioedema.

Children and adolescents

Orladeyo is not recommended in children under 12 years. This is because it has not been studied in this age group. Orladeyo has not been studied in adolescents weighing less than 40 kg.

Other medicines and Orladeyo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Particularly, tell your doctor before taking Orladeyo if you are using:

• thioridazine or pimozide, medicines to treat mental disorders
• amlodipine, a medicine to treat high blood pressure or a type of chest pain called angina
• ciclosporin, a medicine to suppress the immune system, treat severe skin diseases and severe eye or joint inflammation
• dabigatran, a medicine to prevent blood clotting
• rifampicin: a medicine to treat tuberculosis or certain other infections
• desipramine, St. John s wort and other medicines to treat depression called tricyclic antidepressants
• dextromethorphan, a cough-relieving medicine
• digoxin, a medicine to treat heart problems and irregular heartbeat
• fentanyl, a strong painkiller
• midazolam, a medicine to treat sleeping disorders and for anaesthesia
• tolbutamide, a medicine to reduce blood sugar
• oral contraceptives, medicines used for birth control

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 or pharmacist for advice before taking this medicine.

There is limited information on the use of Orladeyo during pregnancy and breast-feeding. As a precaution, it is preferable to avoid the use of Orladeyo during pregnancy and breast-feeding. Your doctor will discuss with you the risks and benefits of taking this medicine.

Women of childbearing potential must use effective contraception during treatment and for at least 1 month following the last dose. Orladeyo is not recommended in women of childbearing potential not using contraception.

Driving and using machines

Orladeyo has no or negligible influence on the ability to drive and use machines.

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 The recommended dose for adults and adolescents from 12 years weighing 40 kg is one capsule once daily.

Orladeyo is not recommended in patients with moderate or severely reduced liver function. As a precautionary measure, this also applies to patients on dialysis.

Method of administration

Take the capsule with food and one glass of water at the same time each day. This can be at any time of the day.

If you take more Orladeyo than you should

Contact your doctor immediately if this occurs.

If you forget to take Orladeyo

Do not take a double dose to make up for a forgotten capsule. Take a missed dose as soon as you remember; however, do not take more than one dose per day.

If you stop taking Orladeyo

It is important to take this medicine on a regular basis and for as long as your doctor prescribes it. Do not stop taking it without approval from 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 can occur with the following frequencies: Very common, may affect more than 1 in 10 people

• headache
• stomach pain, including abdominal (belly) discomfort, abdominal tenderness
• diarrhoea and frequent bowel movements

Common, may affect up to 1 in 10 people

• vomiting
• heartburn
• wind
• blood tests showing increased levels of liver enzymes called ALT and AST
• rash

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 blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Orladeyo contains

• The active substance is berotralstat. Each capsule contains 150 mg berotralstat (as dihydrochloride).
• The other ingredients are:

• starch, pregelatinised, crospovidone (type A), silica, colloidal anhydrous, magnesium stearate, gelatin, titanium dioxide (E 171)
• colourants: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)
• edible printing ink: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520)

What Orladeyo looks like and contents of the pack

Orladeyo capsules have a white opaque body imprinted with 150 and light blue opaque cap imprinted with BCX (19.4 mm 6.9 mm). They are packed in plastic/aluminium blisters in a carton with 7 capsules per blister.

Pack size: 28 or 98 hard capsules

Marketing Authorisation Holder and Manufacturer

• Marketing Authorisation Holder BioCryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HWIreland

• Manufacturer Millmount Healthcare Limited
  Block-7, City North Business Campus,
  Stamullen,
  Co. Meath, K32 YDIreland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: