Leaflet: information for the user

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

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 leaflet. See section 4.

Icatibanto Cipla contains the active ingredient icatibanto.

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

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

Icatibanto blocks bradykinin activity and thereby slows the progression of HAE symptoms during an episode.

No use Icatibanto Cipla

• 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 Icatibanto Cipla:

• If you have angina pectoris (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 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 Cipla 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 Cipla 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

This medication is not recommended for use in children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.

Other Medications and Icatibanto Cipla

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

No interactions of Icatibanto Cipla with other medications are known. If you are taking 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 this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before starting to use this medication.

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

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy due to an AEH crisis or after using this medication.

Icatibanto Cipla contains sodium

This medication contains less than 1 mmol (23 milligrams) of sodium per syringe, 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 Cipla 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 this medication if you have an acute AEH attack.

It is essential to inject Icatibanto Cipla subcutaneously (under the skin) as soon as you notice an acute angioedema attack. Healthcare staff will teach you and the person caring for you how to inject this medication safely, following the prospectus instructions.

When and how often should you use Icatibanto Cipla?

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

Adults

• The recommended dose of Icatibanto Cipla 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 6 hours, you should seek medical advice on the administration of additional Icatibanto Cipla injections. In adults, up to 2 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, consult your doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of this medication 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 acute angioedema attack occur (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 advice.

How should Icatibanto Cipla be administered?

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

This medication 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:

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive Icatibanto Cipla 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.

Inform your doctor immediately if you observe that the symptoms of the crisis worsen after receiving this medication.

Very Frequent(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).

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

• Nausea
• Headache
• Dizziness
• Fever
• Itching
• Rash
• Skin redness
• Abnormal liver function tests

Unknown Frequency(cannot be estimated from available data):

• Hives (urticaria)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish 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.

Composition of Icatibanto Cipla

• The active ingredient is icatibanto. Each pre-filled syringe contains 30 milligrams of icatibanto (in the form of acetate). Each milliliter of solution contains 10 mg of icatibanto
• The other components are sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment) and water (see section 2).

Appearance of the product and contents of the package

Icatibanto Cipla is presented as a transparent and colorless injectable solution in a 3 ml pre-filled syringe made of glass. The package contains a hypodermic needle.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cipla Europe NV

De Keyserlei 58-60, Box 19,

2018 Antwerp, Belgium

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

Netherlands

Local representative

Cipla Europe NV subsidiary in Spain,

C/Guzmán el Bueno, 133 Edif Britannia 28003 Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)