ICATIBANTO AGUETTANT 30 mg Injectable Solution in Pre-filled Syringe EFG

Introduction

Package Leaflet: Information for the User

Icatibant Aguettant 30 mg solution for injection in pre-filled syringe EFG

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

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Icatibant Aguettant and what is it used for

This medicine contains the active substance icatibant.

Icatibant is used to treat acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.

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

Icatibant blocks the action of bradykinin and thus reduces the progression of symptoms of an HAE attack.

2. What you need to know before you use Icatibant Aguettant

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

Warnings and precautions

Consult your doctor before starting icatibant treatment:

• If you have coronary heart disease (reduced blood flow to the heart).
• If you have recently had a stroke.

The side effects related to icatibant are similar to the symptoms of your own illness. Consult your doctor immediately if you notice that the symptoms of the attack worsen after icatibant administration.

In addition:

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

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Icatibant 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.

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

No interactions of icatibant with other medicines are known. If you are taking any medicine that is an angiotensin-converting enzyme inhibitor (ACEI) (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to reduce blood pressure or for any other reason, inform your doctor before using icatibant.

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

If you are breastfeeding, you should not breastfeed your child during the 12 hours following the last administration of icatibant.

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Do not drive or use machines if you feel tired or dizzy as a result of the HAE attack or after using icatibant.

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This medicine contains less than 23 milligrams (1 mmol) of sodium per syringe, and is therefore essentially ‘sodium-free’.

3. How to use Icatibant Aguettant

Follow the instructions for administration of this medicine exactly as told by your doctor. In case of doubt, consult your doctor again.

If you have never been administered icatibant before, the first dose should always be injected by medical or nursing staff. Your doctor will discharge you when he/she considers it safe for you to go home. After discussing with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver can administer icatibant if you have an HAE attack. It is important to inject icatibant subcutaneously (under the skin) as soon as you notice an angioedema attack. Healthcare professionals will teach you and your caregiver how to safely inject icatibant, following the instructions in the package leaflet.

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

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

• If you do not notice an improvement in symptoms after 6 hours, you should seek medical advice about the administration of additional icatibant injections. In adults, up to 2 additional injections can be administered within 24 hours.

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Children and adolescents from 2 to 17 years

• The recommended dose of icatibant 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 symptoms of an angioedema attack appear (e.g. increased skin swelling, especially on the face and neck, or increased abdominal pain).

• See the instructions for use section to determine the dose to be injected.

• If you are unsure about the dose to be injected, consult your doctor, pharmacist or nurse.

-iyour symptoms worsen or do not improve, you should seek medical advice immediately.

How to administer Icatibant Aguettant

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

Icatibant is injected with a short needle into the fatty tissue under the skin of the abdomen (belly). If you have any further questions on the use of this product, 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 (weighing 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) weighing 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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients who receive icatibant notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, redness of the skin and burning). These effects are usually mild and improve without the need for any additional treatment.

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

Additional reactions at the injection site (feeling 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

Frequency not known(cannot be estimated from the available data): Hives (urticaria)

Tell your doctor immediately if you notice that the symptoms of the attack worsen after icatibant administration.

If you experience side effects, consult your doctor, even if they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Aguettant

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 after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the syringe or needle packaging is damaged or if you notice any visible signs of deterioration, such as the solution being cloudy, containing floating particles or having changed color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Icatibant Aguettant

The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). The other ingredients are sodium chloride, glacial acetic acid and sodium hydroxide (for pH adjustment) and water for injections.

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Icatibant Aguettant is presented as a clear and colorless solution for injection in a 3 ml glass pre-filled syringe.

The pack contains a hypodermic needle.

Icatibant Aguettant is available in a single pack of one pre-filled syringe with one needle or in a multipack of three pre-filled syringes with three needles.

Not all pack sizes may be marketed.

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Laboratoire Aguettant

1 rue Alexander Fleming

69007 Lyon

France

Manufacturer responsible

Wessling GmbH

Johann-Krane-Weg 42,

48149 Münster,

Germany

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Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)