Label: information for the user

Adenoscan 30 mg/10 ml, infusion solution

adenosine

Read the entire label carefully before starting to use the medication, as it contains information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or nurse.

- If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label.

1. What is Adenoscan and how it is used

2. What you need to know before Adenoscan is administered

3. How to administer Adenoscan

4. Possible adverse effects

5. Storage of Adenoscan

6. Contents of the package and additional information

Adenoscan contains an active ingredient called adenosine. This belongs to a group of medications called “coronary vasodilators”.

This medication is only for diagnostic use.

Adenoscan is used before a test called “myocardial perfusion imaging” that helps visualize your heart. During this test, they will give you a medication called “radiopharmaceutical”.

Adenoscan works by widening the blood vessels of the heart, allowing blood to flow more freely. This allows the “radiopharmaceutical” medication to access your heart. The doctor can visualize your heart and evaluate its conditions. This procedure is used if you cannot exercise or if it is not possible to perform a stress test.

Do not use this medication and inform your doctor if:

- You are allergic to adenosine or to any of the other components of this medication (listed in section 6).

- You have symptoms of an allergic reaction that include: skin rash, difficulty swallowing or breathing, swelling in the lips, face, throat, or tongue.

- You have severe low blood pressure (hypotension).

- You have unstable angina that is not being treated with medication.

- You have asthma or other severe respiratory problems.

- You are taking a medication called dipiridamol used to thin the blood.

- You have a type of heart failure in which your heart cannot pump enough blood.

- You have problems with your heart rhythm and do not have an implanted pacemaker (second and third degree of atrioventricular block, sinus disease).

- You have been told that you have the "long QT interval syndrome". It is a heart problem that appears in rare cases and can cause a rapid heart rate and fainting.

No use this medication if any of the contraindications affect you. If you are unsure, consult with your doctor or nurse before using Adenoscan.

Warnings and precautions

Consult with your doctor or nurse before using Adenoscan if:

- You have low blood volume (hypovolemia) and it is not adequately corrected with medication treatment.

- You have problems with a part of your nervous system called the "autonomic nervous system".

- You have narrowing of the main arteries in the neck (carotid artery). This means that not enough blood is reaching the brain (cerebrovascular insufficiency).

- You have had or have seizures.

- You have difficulty breathing (bronchospasm).

- You have a heart disease caused by narrowing of your heart valves (valvular stenosis).

- You have inflamed the membrane surrounding your heart (pericarditis) or accumulation of fluid around your heart (pericardial effusion).

- You have a left-to-right shunt in your heart. This means that the blood passes directly from the left side to the right side of your heart.

- You have narrowing of the main left coronary artery that supplies blood to the heart (left main coronary artery stenosis). You have or have recently had a heart attack, severe heart failure, or if you have had a heart transplant in the last year.

- You have a rare heart rhythm. For example, your heartbeat is very fast or irregular (atrial fibrillation or flutter) and particularly if you have a "accessory conduction pathway".

- You have a minor heart problem (first degree of atrioventricular block or branch block). These conditions may worsen temporarily when you are administered Adenoscan.

Consult with your doctor immediately if:

?You experience signs of a stroke. This can present as sudden numbness or weakness in the face, arms, or legs. Other signs are feeling confused, problems with vision, walking, coordination, or balance, difficulty speaking, or difficulty with speech.

?You experience signs of a heart attack (myocardial infarction). Severe chest pain is the most common main symptom. The pain can also go to the jaw and down to your left arm or to both arms.

Also, you may sweat, feel nauseous, and feel dizzy. A small heart attack (myocardial infarction) occasionally occurs without causing pain (a "silent myocardial infarction"). It can be really painless, or, sometimes, the pain is mild and you may think it's just acid reflux or "gas".

Children and adolescents

Adenoscan has not been sufficiently studied in children and adolescents.

Other medications and Adenoscan

Inform your doctor or nurse if you are taking, have taken recently, or may need to take other medications, including those purchased without a prescription. This includes medications that can be bought without a prescription, including herbal remedies. This is because Adenoscan can affect how some medications work. In particular, check with your doctor or nurse if you are taking any of the following:

- Dipiridamol (medication used to thin the blood). Make sure your doctor knows that you are taking dipiridamol. Your doctor may tell you to stop taking dipiridamol 24 hours before Adenoscan is administered or that a lower dose of Adenoscan will be given.

- Aminophylline, theophylline, or other xanthines (medications used to help you breathe). Your doctor may tell you to stop taking them 24 hours before Adenoscan is administered.

Adenoscan with food and drinks

You should avoid foods or drinks that contain xanthines, such as tea, coffee, chocolate, and cola for at least 12 hours before Adenoscan is administered.

Pregnancy and breastfeeding

Consult with your doctor or nurse before using this medication if:

- You are pregnant, may become pregnant, or think you may be pregnant.

Adenoscan should not be administered unless it is clearly necessary.

- You are breastfeeding. Adenoscan should not be administered.

If you are pregnant or breastfeeding, or think you may be pregnant, consult with your doctor or nurse before using this medication.

Adenoscan contains sodium

This medication contains 35.4 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.77% of the recommended daily maximum sodium intake for an adult.

How to Use Adenoscan

- Adenoscan is a hospital-use medication.

- You will be administered Adenoscan by a doctor or nurse. It will be administered through a vein over a period of time (this is called a venous perfusion).

- Your heart and blood pressure will be closely monitored.

What amount of Adenoscan is administered

If you are unsure why you are being administered Adenoscan or have questions about the amount you are being given, ask your doctor or nurse.

Adults (including those 65 years and older)

- The dose is calculated based on your body weight.

- The usual dose is 140 micrograms per kilogram of body weight per minute.

It is administered over a period of 6 minutes through a perfusion pump (slow intravenous injection).

- The Adenoscan dose does not change if you have liver or kidney problems.

If you have received more Adenoscan than you should have

Since this medication is administered by a doctor or nurse, it is unlikely that you will receive more than you should. Your doctor will carefully calculate how much Adenoscan you should receive.

If you receive more medication than you should, the following effects may occur:

- Severe low blood pressure (hypotension).

- Slow heart rate (bradycardia).

- A heart problem (asystole).

Your doctor will continuously monitor your heart during the process.

Since the time Adenoscan stays in the blood is very short, any adverse effect due to an overdose of Adenoscan will cease quickly when the perfusion is interrupted. Sometimes, you may need an injection of a medication called aminophylline or theophylline to help with a possible adverse effect.

If you have more questions about the use of this medication, consult your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. While receiving Adenoscan, you may have one of the following side effects.

If any of the following side effects worsen, inform your doctor or nurse immediately and they will decide whether you should continue with the infusion or not.

Side effects usually resolve in a few seconds or minutes after the infusion has ended, but you should inform your doctor or nurse if you experience any of them.

Very common (may affect more than 1 in 10 patients)

• Redness of the skin with a sensation of heat (flushing).
• Lack of breathing or need to breathe deeply (dyspnea).
• Headache.
• Pain or pressure in the chest.
• Abdominal discomfort.

Common (may affect up to 1 in 10 patients)

• Sensation of dizziness or headache caused by light.
• Rare sensations in the skin such as lack of sensation, tingling, itching, burning, or gradual numbness (paresthesia).
• Low blood pressure.
• A heart problem called atrioventricular block.
• Irregular or rapid heartbeats (arrhythmias).
• Dry mouth.
• Discomfort in the throat, jaw, or neck.

Uncommon (may affect up to 1 in 100 patients)

• Metallic taste in the mouth.
• Sweating.
• Discomfort in the legs, arms, or back.
• Sensation of weakness, pain, or general discomfort.
• Nervous sensation.
• Slow heart rate (bradycardia).

Rare (may affect up to 1 in 1,000 patients)

• Difficulty breathing (bronchospasm).
• Stuffy nose.
• Sensation of drowsiness.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Sudden need to urinate.
• Discomfort in the nipples.
• Trembling.

Very rare (may affect up to 1 in 10,000 patients)

• Severe difficulty breathing or breathing problems.
• Redness, pain, or swelling at the injection site.

Other side effects (frequency cannot be estimated from available data)

• Allergic reactions including swelling of the face or throat, and skin reactions such as urticaria or skin rash.

• Severe heart problems that may cause death (asystole) or irregular heartbeats.
• Seizures.
• Fainting.
• Lack of breathing (apnea).
• Sensation of dizziness (nausea) or dizziness (vomiting).
• Spasm of the coronary artery that may cause a heart attack.

If any of the following side effects worsen, inform your doctor or nurse immediately and they will decide whether you should continue with the infusion or not. Side effects usually resolve in a few seconds or minutes after the infusion has ended, but you should inform your doctor or nurse if you experience any of them.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Your doctor, nurse, or hospital pharmacist will store this medication in a safe place where children cannot reach or see it.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not refrigerate.

This medication is for single use only and once opened, it must be used immediately. Any fraction of the vial that is not used must be discarded.

This medication should not be used if your doctor or nurse notes any particles in the solution, or any color change before administration. If the product's appearance has changed, the vial must be discarded.

Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Adenoscan

- The active ingredient is adenosine. Each vial of 10 ml contains 30 mg of adenosine (3 mg per ml)

- The other components are sodium chloride and water for injection.

- The pH is adjusted with hydrochloric acid and/or sodium hydroxide.

- The product is sterilized by filtration.

- The product is pyrogen-free.

Appearance of the product and contents of the pack

Adenoscan is a sterile, transparent, and colorless solution for perfusion.

Cada envase contiene 6 viales de 30 mg/10 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing:

Famar Health Care Services Madrid, S.A.U.

Avenida de Leganés, 62

28923 Alcorcón Madrid

or

Cenexi HSC

2 rue Louis Pasteur - Herouville

Saint-Clair 14200 France

or

Sanofi-Aventis Deutschland GmbH

Industriepark Hoechst-Brueningstraße 50

65926 Frankfurt am Main

Germany

This medicinal product is authorized in the Member States of the EU with the following

names:

FranceAdenoscan 30 mg/10 ml, solution for perfusion

GermanyAdenoscan

ItalyADENOSCAN

PortugalAdenoscan

SpainAdenoscan 30 mg /10 ml solution for perfusion

United-KingdomAdenoscan 30 mg/10 ml, solution for infusion.

Date of the last review of this leaflet:August 2023

The following information is intended only for healthcare professionals:

Practical information for the preparation and handling of Adenoscan

Solution for perfusion of 30 mg/10 ml (see also Section 3)

Dosage and administration

Adenoscan is for use in hospitalswith monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary.

It should be administered following the same procedure as in stress tests, in a centre equipped with cardiac monitoring and cardio-respiratory resuscitation facilities. During the administration of Adenoscan, continuous ECG monitoring is necessary since arrhythmia with a risk to life may occur. Heart rate and blood pressure should be continuously monitored.

Dosage

Adults

1. Adenoscan should be administered undiluted as a continuous intravenous peripheral perfusion at a rate of 140 μg/kg/min for 6 minutes using a perfusion pump. It is recommended to separate the intravenous points of Adenoscan and the radionuclide to avoid an "Adenoscan bolus" effect.

2. After 3 minutes of Adenoscan perfusion, the radionuclide is injected to allow sufficient time for the peak coronary blood flow to occur. The optimal vasodilatory effect is achieved with 6 minutes of Adenoscan perfusion.

3. To avoid an "Adenoscan bolus" effect, blood pressure should be determined in the opposite arm to the Adenoscan perfusion. The following table is provided as a guide for adjusting the perfusion rate of undiluted Adenoscan according to body weight (total dose of 0.84 mg/kg).

Pediatric population

No safety and efficacy data are available for adenosine in children aged 0–18 years. The available data are described in section 5.1 but no recommendation can be made on dosage.

Geriatric population

See the recommended dosage for adults.

Overdose

An overdose would cause severe hypotension, bradycardia, or asystole. The plasma half-life of adenosine is very short and any side effects of Adenoscan (if they occur) would resolve very quickly upon stopping the perfusion. Administration of aminophylline or theophylline by intravenous route may be necessary.

Incompatibilities

Since no compatibility studies have been performed, this product should not be mixed with other medicinal products.

Shelf-life

The shelf-life of the product without opening is 3 years.

Once opened, it should be used immediately.

Special precautions for storage

Do not refrigerate.

Special precautions for disposal and other manipulations

This product is for single use only.

Visual inspection of the colour and absence of particles should be performed before administration of the product. If the visual appearance has changed, the vial should be discarded.

Disposal of unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations.

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