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The product code(s) for this leaflet is: PLGB 53835/0005.
Icatibant 30 mg Solution for Injection in pre-filled Syringe
Icatibant 30 mg Solution for Injection in pre-filled Syringe
icatibant
1. What Icatibant Injection is and what it is used for
2. What you need to know before you use Icatibant Injection
3. How to use Icatibant Injection
4. Possible side effects
5. How to store Icatibant Injection
6. Contents of the pack and other information
This medicine contains the active substance icatibant.
Icatibant Injection is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
Icatibant Injection blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
Talk to your doctor before using Icatibant Injection:
Some of the side effects connected with icatibant are similar to the symptoms of your disease. Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received this medicine.
In addition:
This medicine 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.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Icatibant Injection is not known to interact with other medicines. If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, ask your doctor before receiving this medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before starting to use this medicine.
If you are breast-feeding do not breast-feed for 12 hours after you have last received this medicine.
Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using this medicine.
The injection solution contains less than 1 mmol (23 mg) of sodium per dose, so it is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
If you have never received Icatibant Injection previously, your first dose of this medicine will always be injected by your doctor or nurse. Your doctor will tell you when it is safe for you to go home.
After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Icatibant Injection or your caregiver may inject this medicine for you when you have an HAE attack.
It is important that Icatibant Injection is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema. Your healthcare provider will teach you and your caregiver how to safely inject this medicine by following the instructions in the Package Leaflet.
Your doctor has determined the exact dose of this medicine and will tell you how often it should be used.
Icatibant Injection is intended for 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 in the abdomen (tummy).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The instructions include the following main steps:
1) Preparing the pre-filled syringe
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less
2b) Preparing the syringe and needle for injection (all patients)
3) Preparing the injection site
4) Injecting the solution
5) Disposal of the injection material
1) Preparing the pre-filled syringe
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:
2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
3) Preparing the injection site
4) Injecting the solution
5) Disposal of the injection material
Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Icatibant Injection will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). These effects are usually mild and clear up without the need for any additional treatment.
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received this medicine.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Not known (frequency cannot be estimated from the available data):
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 stated on the label and box 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 there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Icatibant Injection is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. A hypodermic needle is included in the pack.
Icatibant Injection is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected].
This leaflet was last revised in March 2022