Label: information for the user

Icatibant Piramal 30 mg injectable solution in pre-filled syringe EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Icatibanto Piramal contains the active ingredient icatibanto.

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

In HAE, concentrations of a substance present in the blood called bradykinin increase, which produces symptoms such as swelling, pain, nausea, and diarrhea.

Icatibanto blocks the activity of bradykinin and, therefore, slows the progression of symptoms.

No use Icatibanto Piramal

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

Warnings and Precautions

Consult your doctor before starting to use Icatibanto.

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

Some of the side effects related to Icatibanto 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 this medication.

Additionally:

• You or your caregiver must learn the technique of subcutaneous injection (under the skin) before self-administering or having your caregiver administer this medication to you.
• Immediately after self-administering Icatibanto or having your caregiver administer it to you 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 Icatibanto self-administered or administered by your caregiver, you must consult your doctor about the administration of additional injections of this medication. In adult patients, up to 2 additional injections may be administered within a 24-hour period.

Children and Adolescents

Icatibanto 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 Icatibanto Piramal

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

No interactions of Icatibanto with other medications are known. If you are taking any medication that is 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 receiving this medication.

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 Icatibanto.

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

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy as a result of the AEH crisis or after using Icatibanto.

Icatibanto Piramal contains sodium

This medication contains less than 23 milligrams (1 mmol) of sodium per injectable solution, making it 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 Icatibanto 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 who takes care of you can administer Icatibanto if you have an AEH crisis. It is essential to inject Icatibanto subcutaneously (under the skin) as soon as you notice a crisis of angioedema. Healthcare personnel will teach you and the person who takes care of you how to inject this medication safely, following the prospectus instructions.

When and how often should you use Icatibanto Piramal?

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

Adults

• The recommended dose of Icatibanto is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the angioedema crisis (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, you should consult a doctor about the administration of additional Icatibanto injections. In adults, up to two additional injections can be administered within 24 hours.

• You should not receive more than 3 injections in a 24-hour period and if you need more than 8 injections in a month, you should consult a doctor.

Children and adolescents from 2 to 17 years old

• The recommended dose of Icatibanto is one injection of 1 ml up to a maximum of 3 ml, depending on body weight, injected subcutaneously (under the skin) as soon as symptoms of an angioedema crisis appear (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, you should seek immediate medical attention.

How should Icatibanto Piramal be administered?

This medication is administered by subcutaneous injection (under the skin). Each syringe should be used only once.

Icatibanto is injected with a short needle into the fatty tissue located under the skin of the abdomen (stomach).

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 to adults, adolescents, or children over 2 years old (who weigh at least 12 kg).

The instructions include the following main steps:

1)General information

2a)Preparation of the syringe for children and adolescents (2-17 years) who weigh 65 kg or less

2b)Preparation of the syringe and needle for injection (all patients)

1. Preparation of the injection site
2. Injection of the solution
3. Disposal of injection materials

Step-by-step instructions for injection

• Clean the work surface area to be used before starting the process.

• Wash your hands with water and soap

• Extract the pre-loaded syringe from the container.

• Loosen and remove the cap from the end of the pre-loaded syringe.

• Leave the pre-loaded syringe once the cap has been loosened.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive Icatibant 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 observe that the symptoms of the attack worsen after receiving this medication.

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 or pharmacist, even if it is possible adverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.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.

Do not store at a temperature above 25°C. 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.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Icatibanto Piramal Composition

- The active ingredient is icatibanto.Cada jeringa precargada contiene 30 miligramos de icatibanto (como acetato). Cada ml de la solución contiene 10 mg de icatibanto.

- The other components are: sodium chloride, glacial acetic acid (buffering agent), sodium hydroxide (to adjust pH) and water for injection (see section 2).

Product Appearance and Packaging Contents

Icatibanto Piramal is presented as a transparent and colorless injectable solution in a 3 ml pre-filled syringe.

The packaging contains a hypodermic needle.

Icatibanto is available in a single pre-filled syringe with a needle or in a multiple packaging of three pre-filled syringes with three needles.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor),

Voorschoten 2252 TR

Netherlands

Responsible Manufacturer

Laboratorios Eurofins PROXY

(B.V.)

Archimedesweg 25

2333 CM Leiden

Holland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industripark

Paola PLA 3000

Malta

For more information about this medication, please contact

the local representative of the marketing authorization holder:

Euromed Pharma Spain, S.L.C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

This medication is authorized in the European Economic Area (EEA) member states with the following names:

Denmark: Icatibant Piramal

Germany: Icatibant Piramal 30 mg Injektionslösung in einer Fertigspritze

Spain: Icatibanto Piramal 30 mg solución inyectable en jeringa precargada EFG

France: Icatibant Piramal 30 mg solución inyectable, seringue pré-remplie

Italy: Icatibant Piramal

Last review date of thisleaflet: 09/2021

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)