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Package Leaflet: Information for the User
Icatibant Stada 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.
of side effects that are not listed in this leaflet. See section 4.
Contents of the pack
Icatibant Stada contains the active substance icatibant.
This medicine is used to treat the symptoms of hereditary angioedema (HAE) in adults, adolescents and children over 2 years of age.
In HAE, the levels of a substance in the blood called bradykinin increase, producing symptoms such as swelling, pain, nausea and diarrhea.
Icatibant blocks the action of bradykinin and thus slows down the progression of the symptoms of an HAE attack.
Do not use Icatibant Stada
Warnings and precautions
Consult your doctor before starting to use icatibant:
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 attack worsen after icatibant is administered.
In addition:
Children and adolescents
This medicine is not recommended for children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Other medicines and Icatibant Stada
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 (ACE inhibitor) (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, inform your doctor before using this medicine.
Pregnancy and breastfeeding
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.
Driving and using machines
Do not drive or use machines if you feel tired or dizzy as a result of the HAE attack or after using icatibant.
Icatibant Stada contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.
Follow the instructions for administration of this medicine exactly as indicated 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. The doctor will discharge you when he considers it safe for you to go home.
After discussing it with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver can administer this medicine if you have an HAE attack.
It is essential to inject icatibant subcutaneously (under the skin) as soon as you notice an angioedema attack. The healthcare staff will teach you and your caregiver how to inject this medicine safely, following the instructions in the package leaflet.
When and how often should you use Icatibant Stada?
Your doctor has determined the exact dose of this medicine and will tell you how often to use it.
Adults
Children and adolescents from 2 to 17 years
Method of administration
Icatibant is administered by subcutaneous injection (under the skin). Use each syringe only once.
This medicine 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 medicine, ask your doctor or pharmacist.
The following step-by-step instructions are intended for:
The instructions include the following main steps:
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)
Step-by-step instructions for injection
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2a) Preparation of the syringe for children and adolescents (2-17 years) who weigh 65 kg or less: |
Important information for healthcare professionals and caregivers: When the dose is less than 30 mg (3 ml), the following equipment is needed to extract the correct dose (see information below):
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The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below). Table 1: Dosage schedule for children and adolescents
Patients who weigh more than 65 kgwill use the entire contents of the pre-filled syringe (3 ml). If you are unsure about the volume of solution to extract, consult your doctor, pharmacist or nurse
Avoid touching the ends of the connector and the tips of the syringes to prevent contamination
Transfer the icatibant solution to the graduated syringe:
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If there is air in the graduated syringe:
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2b) Preparation of the syringe and needle for injection: All patients (adults, adolescents and children) |
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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.
Tell your doctor immediately if you notice that the symptoms of the attack worsen after receiving icatibant.
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 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.
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 label and carton after “EXP”. The expiry date is the last day of the month shown.
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; for example, if the solution is cloudy, if it contains floating particles or if the color of the solution has changed.
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.
Composition of Icatibant Stada
Appearance of Icatibant Stada and Packaging Contents
Icatibant is presented as a clear and colorless injectable solution in a 3 ml pre-filled glass syringe. The packaging contains a hypodermic needle.
Icatibant is available in a single unit package of one pre-filled syringe with one needle or in a multiple package of three pre-filled syringes with three needles.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratory Stada, S.L.
C/Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
or
STADA Arzneimittel GmbH
Muthgasse 36/2 1190 Wien,
Austria
or
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
or
Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
Netherlands
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/
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