Package Leaflet: Information for the User

Icatibant Accord 30 mg Pre-filled Syringe EFG

icatibant

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Icatibant Accord contains the active ingredient icatibant.

Icatibant Accord is used for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children over 2 years old.

In HAE, blood levels of a substance called bradykinin increase, producing symptoms such as swelling, pain, nausea, and diarrhea.

Icatibant Accord blocks the activity of bradykinin and, therefore, slows the progression of symptoms of a HAE crisis.

No use Icatibant Accord

• If you are allergic to icatibant or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use Icatibant Accord:

• If you suffer from angina pectoris (decreased blood flow to the heart).
• If you have recently had a stroke.

The side effects related to Icatibant Accord are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the crisis worsen after you are administered Icatibant Accord.

Additionally:

• You or your caregiver must learn the technique of subcutaneous injection (under the skin) before self-administering or having your caregiver administer Icatibant Accord.
• Immediately after self-administering Icatibant Accord or having your caregiver administer it while experiencing a laryngeal crisis (obstruction of the upper airway), you must seek medical attention at a medical institution.
• If your symptoms do not resolve after an injection of self-administered or caregiver-administered Icatibant Accord, you must consult your doctor about the administration of additional injections of Icatibant Accord. In adult patients, up to 2 additional injections can be administered within 24 hours.

Children and Adolescents

Icatibant Accord is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.

Other Medications and Icatibant Accord

Inform your doctor if you are taking, have recently taken, or may need to take any other medication.

No interactions of Icatibant Accord with other medications are known. If you are taking an angiotensin-converting enzyme inhibitor (ACEI) (for example: captopril, enalapril, ramipril, quinapril, lisinopril) to reduce blood pressure or for any other reason, inform your doctor before using Icatibant Accord.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before starting to use Icatibant Accord.

If you are breastfeeding, do not breastfeed your child for 12 hours after the last administration of Icatibant Accord.

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy due to the AEH crisis or after using Icatibant Accord.

Icatibant Accord contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per syringe; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

If you have never received Icatibant Accord before, the first dose must always be injected by medical or nursing staff. Your doctor will discharge you when they consider it safe for you to go home. After analyzing it with your doctor or nurse, and after learning the technique for subcutaneous injections (under the skin), you or the person caring for you can administer Icatibant Accord if you have an acute angioedema attack. It is essential to inject Icatibant Accord subcutaneously (under the skin) as soon as you notice an acute angioedema attack. Healthcare personnel will teach you and the person caring for you how to inject Icatibant Accord safely, following the package insert instructions.

When and how often to use Icatibant Accord

Your doctor has determined the exact dose of Icatibant Accord and will tell you how often to use it.

Adults

• The recommended dose of Icatibant Accord is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the acute angioedema attack (for example, with increased skin swelling, especially on the face and neck, or increased abdominal pain).

• If you do not notice an improvement in symptoms, after six hours, seek medical advice on the administration of additional Icatibant Accord injections. In adults, up to two additional injections can be administered within 24 hours.

• You should not receive more than three injections in a 24-hour period and if you need more than eight injections in a month, seek medical advice.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Accord is one injection of 1 ml up to a maximum of 3 ml based on body weight administered subcutaneously (under the skin) as soon as you notice symptoms of an acute angioedema attack (for example, increased skin swelling, especially on the face and neck, or increased abdominal pain).

• See the usage instructions section to see the dose you should inject.

• If you are unsure about the dose you should inject, consult your doctor, pharmacist, or nurse.
• If your symptoms worsen or do not improve, seek medical advice immediately.

How to administer Icatibant Accord

Icatibant Accord is administered via subcutaneous injection (under the skin). Each syringe should only be used once.

Icatibant Accord is injected with a short needle into the fatty tissue located under the skin of the abdomen (lower abdomen). If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

The following step-by-step instructions are intended for:

• Self-administration (adults)
• Administration by a caregiver or healthcare professional for adults, adolescents, or children over 2 years old (who weigh at least 12 kg).

The instructions include the following main steps:

Step-by-step instructions for injection

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive Icatibant Accord notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, skin redness, and burning). These effects are usually mild and improve without the need for additional treatment.

Very common (may affect more than 1 in 10 people):

Additional reactions at the injection site (sensation of pressure, bruising, decreased sensitivity and/or numbness, increased skin rash with itching and heat).

Common (may affect up to 1 in 10 people):

Nausea

Headache

Dizziness

Fever

Itching

Rash

Redness of the skin

Abnormal liver function tests

Unknown frequency (cannot be estimated from available data):

Hives (urticaria)

Inform your doctor immediately if you notice that the symptoms of the crisis worsen after receiving Icatibant Accord.

If you experience adverse effects, consult your doctor, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for its conservation. Do not freeze.

Do not use this medication if you observe that the syringe or needle container is damaged or if you observe visible signs of deterioration; for example, if the solution is cloudy, if it contains floating particles or if the solution color has changed.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help to protect the environment.

Composition of Icatibant Accord

The active ingredient is icatibant. Each pre-filled syringe of 3 ml contains acetate of icatibant equivalent to 30 milligrams of icatibant. Each ml of solution contains 10 mg of icatibant. The other components are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injection.

Appearance of Icatibant Accord and contents of the packaging

Icatibant Accord is presented as a transparent and colourless practically particle-free solution, in a pre-filled syringe of 3 ml made of glass. The packaging contains a hypodermic needle.

Icatibant Accord is available in a single pre-filled syringe packaging with a hypodermic needle or in a packaging of three pre-filled syringes with three needles.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est 6th floor,

08039 Barcelona, Spain

Manufacturer

Accord Healthcare Polska Sp.z.o.o.

ul. Lutomierska 50,

95-200, Pabianice,

Poland

Or

Accord Healthcare B.V.

Winthontlaan 200, 3526KV Utrecht

Netherlands

Last review date of this leaflet: {MM/AAAA}.

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.There are also links to other websites about rare diseases and orphan medicines.