ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Icatibant Glenmark 30 mg Solution for Injection in Pre-filled Syringe EFG

icatibant

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 Package Leaflet

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

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

Icatibant Glenmark 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 above.

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

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

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

Do not use Icatibant Glenmark

• 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 treatment with icatibant:

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

Side effects related to icatibant are similar to the symptoms of your disease. Consult your doctor immediately if you notice that your attack symptoms worsen after you have been given icatibant.

Also:

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

Children and adolescents

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

Other medicines and Icatibant Glenmark

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 (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to lower your blood pressure or for any other reason, inform your doctor before using icatibant.

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 for advice before taking this medicine.

If you are breast-feeding, you should not breast-feed your child during the 12 hours following the last administration of icatibant.

Driving and using machines

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

Icatibant Glenmark contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per syringe, and is therefore essentially “sodium-free”.

3. How to use Icatibant Glenmark

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor again.

If you have never been given icatibant before, the first dose must 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 carer can administer Icatibant Glenmark if you have an HAE attack.

It is important to inject Icatibant Glenmark subcutaneously (under the skin) as soon as you notice an attack of angioedema. Healthcare staff will teach you and your carer how to inject icatibant safely, following the instructions in the package leaflet.

When and how often to use Icatibant Glenmark

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

Adults

• The recommended dose of icatibant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice an attack of angioedema (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 injections of Icatibant Glenmark. 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 an injection of 1 ml up to a maximum of 3 ml depending 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).
• Refer to the section on instructions for use to see the dose that you should inject.
• If you are not sure about the dose to inject, consult your doctor, pharmacist or nurse.

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Administration of Icatibant Glenmark

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

This medicine is injected with a short needle into the fatty tissue under the skin of the abdomen (tummy).

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 carer or healthcare professional for adults, adolescents or children over 2 years (weighing at least 12 kg).

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 the injection materials

Step-by-step instructions for administration

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Almost all patients who receive Icatibant Glenmark 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.

Consult your doctor immediately if you notice that your HAE attack symptoms worsen after you have been given this medicine.

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)

Reporting of side effects

If you experience 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 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 Glenmark

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 that month.

Do not store above 25°C. Do not freeze.

Do not use this medicine if you notice that the syringe or needle packaging is damaged or if you notice visible signs of deterioration, e.g. if the solution is cloudy, contains particles or has changed colour.

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

6. Packaging Contents and Additional Information

Composition of Icatibant Glenmark

• The active ingredient is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each ml of solution contains 10 mg of icatibant.
• The other components are sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment), and water for injectable preparations (see section 2).

Appearance of Icatibant Glenmark and Packaging Contents

Icatibant Glenmark is presented as a clear and colorless injectable solution in a 3 ml pre-filled glass syringe. The packaging contains a hypodermic needle.

Icatibant Glenmark is available in a single-unit packaging of one pre-filled syringe with a needle or in a multi-unit packaging of three pre-filled syringes with three needles.

Only certain packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate, Paola

PLA 3000

Malta

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM Leiden

Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:September 2021.

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