ADENOSCAN 30 mg/10 ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Adenoscan 30 mg/10 ml, Solution for Infusion

adenosine

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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What Adenoscan is and what it is used for
2. What you need to know before you are given Adenoscan
3. How Adenoscan is given
4. Possible side effects

5 Storage of Adenoscan

1. Contents of the pack and other information

1. What Adenoscan is and what it is used for

Adenoscan contains the active substance adenosine, which belongs to a group of medicines called “coronary vasodilators”.

This medicine is for diagnostic use only.

Adenoscan is used before a test called “myocardial perfusion imaging” which is used to visualize your heart. During this test, you will be given a medicine called a “radiopharmaceutical”.

Adenoscan works by widening the blood vessels of the heart, allowing blood to flow more freely. This allows the “radiopharmaceutical” medicine to reach your heart. Your doctor can then visualize your heart and assess its condition. This procedure is used if you are unable to exercise or if a stress test is not possible.

2. What you need to know before you are given Adenoscan

Do not use this medicine and tell your doctor if:

• You are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6).
• You have symptoms of an allergic reaction, including: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

You have very low blood pressure (severe hypotension).

• You have unstable angina that is not being treated with medicines.
• You have asthma or other severe respiratory problems.
• You are taking a medicine called dipyridamole, used to thin the blood.

You have a type of heart failure where your heart is unable to pump enough blood.

• You have problems with your heart rhythm and do not have a pacemaker (second or third degree atrioventricular block, sick sinus syndrome).

You have been told that you have the “long QT syndrome”. This is a rare heart problem that can cause a fast and irregular heartbeat and fainting.

Do not use this medicine if any of the contraindications apply to you. If you are not sure, consult your doctor or nurse before using Adenoscan.

Warnings and precautions

Tell your doctor or nurse before using Adenoscan if:

• You have low blood volume (hypovolemia) and it is not corrected with 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 your brain (cerebrovascular insufficiency).

You have had seizures or convulsions.

• You have difficulty breathing (bronchospasm).
• You have a heart condition caused by narrowing of the heart valves (valvular stenosis).

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

• You have a heart condition where blood flows directly from the left side to the right side of your heart.

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

• You have an irregular heartbeat. For example, your heartbeat is very fast or irregular (atrial fibrillation or atrial flutter) and in particular if you have an “accessory conduction pathway”.

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

Tell your doctor immediately if:

you experience signs of a stroke. This can appear as sudden numbness or weakness in the face, arms or legs. Other signs may include feeling confused, problems with vision, walking, coordination or balance, problems speaking or difficulty talking.

you experience signs of a heart attack (myocardial infarction). Severe chest pain is the most common symptom. The pain may also spread to your jaw and down your left arm or to both arms.

You may also sweat, feel nauseous, and feel dizzy. A small heart attack (myocardial infarction) may occasionally occur without causing pain (a "silent myocardial infarction"). It may be really painless, or the pain may be mild and you may think it is just heartburn or "gas".

Children and adolescents

The use of Adenoscan in children and adolescents has not been studied sufficiently.

Other medicines and Adenoscan

Tell your doctor or nurse if you are using, have recently used, or might use other medicines, including those bought without a prescription, including herbal medicines. This is because Adenoscan may affect how some medicines work. In particular, check with your doctor or nurse if you are taking any of the following:

• Dipyridamole (a medicine used to thin the blood). Make sure your doctor knows you are taking dipyridamole. Your doctor may tell you to stop taking dipyridamole 24 hours before you are given Adenoscan or to give you a lower dose of Adenoscan.

Aminophylline, theophylline, or other xanthines (medicines used to help you breathe). Your doctor may tell you to stop taking them 24 hours before you are given Adenoscan.

Adenoscan with food and drinks

Food and drinks containing xanthines, such as tea, coffee, chocolate, and cola, should be avoided for at least 12 hours before you are given Adenoscan.

Pregnancy and breastfeeding

Ask your doctor or nurse for advice before using this medicine if:

• You are pregnant, might be pregnant, or are planning to become pregnant.

Adenoscan should not be given unless clearly necessary.

• You are breastfeeding. You should not be given Adenoscan.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Adenoscan contains sodium

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

3. How to use Adenoscan

How to use Adenoscan

• Adenoscan is a hospital medicine.
• It will be given to you by a doctor or nurse. It will be given into a vein over a period of time (this is called intravenous infusion).

Your heart and blood pressure will be closely monitored.

How much Adenoscan is given

If you are not sure why you are being given Adenoscan or have questions about the amount you are being given, ask your doctor or nurse.

Adults (including the elderly)

• The dose is calculated according to your body weight.
• The usual dose is 140 micrograms per kilogram of body weight, per minute.

It is given over a period of 6 minutes through an infusion pump (slow injection into a vein).

If you have been given more Adenoscan than you should

Since this medicine is given by a doctor or nurse, it is unlikely that you will be given too much. Your doctor will carefully calculate how much Adenoscan you should be given.

If you are given too much medicine, the following effects may occur:

• Very low blood pressure (severe hypotension).
• Slow heartbeat (bradycardia).
• A heart problem (asystole).

Your doctor will continuously monitor your heart during the procedure.

Since the time adenosine stays in the blood is very short, any side effects due to an overdose of Adenoscan will stop quickly when the infusion is stopped. Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. While you are receiving Adenoscan, you may have one of the following side effects.

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

Side effects usually go away within a few seconds or minutes after the infusion has stopped, but you should tell your doctor or nurse if you experience any of them.

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

• Flushing of the skin with a feeling of heat (flushing).
• Shortness of breath or need to breathe deeply (dyspnea).
• Headache.
• Chest pain or pressure in the chest.
• Abdominal discomfort.

Common (may affect up to 1 in 10 people)

• Feeling of dizziness or lightheadedness.
• Unusual sensations in the skin, such as numbness, tingling, itching, burning, or a feeling of gradual tingling (paresthesia).
• Low blood pressure.
• A heart problem called atrioventricular block.
• Fast or irregular heartbeats (arrhythmias).
• Dry mouth.
• Discomfort in the throat, jaw, or neck.

Uncommon (may affect up to 1 in 100 people)

• Metallic taste.
• Sweating.
• Discomfort in the legs, arms, or back.
• Feeling of weakness or pain or general discomfort.
• Feeling anxious.
• Slow heartbeat (bradycardia).

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

• Difficulty breathing (bronchospasm).
• Nasal congestion.
• Feeling of drowsiness.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Feeling of sudden need to urinate.
• Discomfort in the nipples.
• Tremors.

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

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

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

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

• Severe heart problems that can cause death (asystole) or irregular heartbeats.
• Seizures (convulsions).
• Fainting.
• Shortness of breath (respiratory arrest).
• Feeling of nausea (nausea) or vomiting.
• Spasm of the coronary artery that can cause a heart attack.

If any of the following side effects get worse, tell your doctor or nurse immediately and they will decide whether you should continue with the infusion or not. Side effects usually go away within a few seconds or minutes after the infusion has stopped, but you should tell your doctor or nurse if you experience any of them.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adenoscan

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

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Do not refrigerate.

This medicine is for single use only and once opened, it should be used immediately. Any unused fraction of the vial should be discarded.

This medicine should not be used if your doctor or nurse notices any particles in the solution or any coloration before administration. If the appearance of the product has changed, the vial should be discarded.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Adenoscan

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

The other components are sodium chloride and water for injectable preparations.

Appearance of the Product and Container Contents

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

Each container contains 6 vials of 30 mg/10 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

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 under the following names:

Names:

France Adenoscan 30 mg/10 ml, solution for infusion

Germany Adenoscan

Italy ADENOSCAN

Portugal Adenoscan

Spain Adenoscan 30 mg /10 ml solution for infusion

United Kingdom Adenoscan 30 mg/10 ml, solution for infusion.

Date of the Last Revision of this Prospectus:August 2023

The following information is intended only for healthcare professionals:

Practical Information for the Preparation and Handling of Adenoscan

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

Posology and Method of Administration

Adenoscan is for use in hospitals with 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 center that has facilities for cardiac monitoring and cardio-respiratory resuscitation. During the administration of Adenoscan, continuous ECG monitoring is necessary as arrhythmia with a risk to the patient's life may occur. Heart rate and blood pressure should be continuously monitored.

Posology

Adults

1. Adenoscan should be administered undiluted in the form of a continuous peripheral intravenous infusion at a rate of 140 μg/kg/minute for six minutes using an infusion pump. It is recommended to separate the points of intravenous administration of Adenoscan and the radionuclide to avoid a "bolus" effect of adenosine.

1. After three minutes of Adenoscan infusion, 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 infusion.

1. To avoid a "bolus" effect of adenosine, blood pressure should be determined in the arm opposite to that of the Adenoscan infusion. The following table is given as a guideline for adjusting the infusion rate of undiluted Adenoscan, according to body weight (total dose of 0.84 mg/kg).

Pediatric Population

The safety and efficacy of adenosine in children from 0 to 18 years have not been established. The available data are described in section 5.1, but no recommendation can be made on the posology.

Elderly Patients

See the recommended dosage for adults.

Overdose

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

Incompatibilities

As compatibility studies have not been conducted, this product should not be mixed with other medications.

Shelf Life

The shelf life of the unopened product is 3 years.

Once opened, it should be used immediately.

Special Precautions for Storage

Do not refrigerate.

Special Precautions for Disposal and Other Handling

The product is for single use.

It should be visually inspected for color and absence of particles before administration of the product. If the visual appearance has changed, the vial should be discarded.

The disposal of the unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.

Detailed 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