Patient Information Leaflet

Adenocor 6 mg/2 ml injectable solution

Adenosine

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Adenocor and what it is used for

2.What you need to know before starting to use Adenocor

3.How to use Adenocor

4.Possible side effects

5Storage of Adenocor

6.Contents of the pack and additional information

Adenocor is a coronary vasodilator that increases blood flow to the heart muscle.

This medication is used for the diagnosis and treatment of some heart rhythm disturbances.

In children, Adenocor is used:

To return your child's heart rhythm to normal if your child has a heart rhythm problem called paroxysmal supraventricular tachycardia (PSVT).

Do not use Adenocor

• If you are allergic to adenosine or any of the other components of this medication (listed in section 6).
• If you have certain heart conditions such as coronary sinus disease, certain atrioventricular blockages (except in patients with an artificial pacemaker functioning); or heart failure.
• If you have the long QT syndrome, which is an abnormality of the heart's electrical system, that may cause an abnormal heart rhythm (arrhythmia), fainting or loss of consciousness (syncope) and even sudden death.
• If you have severe hypotension, a condition in which a person's blood pressure is much lower than usual, which may cause symptoms such as dizziness or lightheadedness.

-If you have asthma or certain respiratory problems such as Chronic Obstructive Pulmonary Disease (COPD) with bronchospasm (closure of the bronchioles).

Warnings and precautions

Consult your doctor before starting to use Adenocor:

• If you have some heart problems, including severe heart failure, slow heart rate, or have recently had a heart attack.
• In case of minor problems in atrioventricular conduction, as they may be exacerbated during perfusion.
• If you are a patient susceptible to seizures, as adenosine may trigger them.
• In case of atrial fibrillation or flutter, which is a heart rhythm disorder (arrhythmia) that generally involves a rapid heart rate in which the upper chambers of the heart (atria) are stimulated to contract in a very disorganized and abnormal manner, and has an accessory conduction pathway, as it may develop an increase in conduction through the anomalous pathway.
• In case of left coronary artery stenosis, valvular stenosis, uncorrected hypovolemia (decrease in circulating blood volume), pericarditis (inflammation of the membrane that covers the heart, pericardium) or pericardial effusion, autonomic dysfunction or carotid artery stenosis with cerebrovascular insufficiency.
• If you are taking dipiridamol (medication for the treatment of blood clotting problems).

In patients with recent heart transplant (less than 1 year) an increase in the heart's sensitivity to adenosine has been observed.

If you are under 18 years old

In children with a heart rhythm problem called "Wolff-Parkinson-White (WPW) syndrome", Adenocor may cause abnormal heart rhythm unexpectedly.

Using Adenocor with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

The administration of adenosinealong with other drugs may modify its effects. Inform your doctor or pharmacist if you are taking:

• dipiridamol (medication for the treatment of blood clotting problems).
• aminophylline, theophylline or other xanthines (medications for the treatment of asthma or bronchitis). These medications should not be taken in the 24 hours prior to administration of this medication.

Using Adenocor with food and drinks

The administration of this medicationalong with food or drinks may change its effects.

You should not take tea, cola, coffee or chocolate, or eat chocolate for at least 12 hours before administration of the medication.

Pregnancy and breastfeeding

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

This medicationshould not be administeredduring pregnancy unless the doctor considers that the benefits outweigh the risks.

This medicationshould not be usedduring breastfeeding, as it is not known if it passes into breast milk.If the doctor considers that adenosine treatment is essential, another form of feeding for the baby should be considered.

Adenocor contains sodium

This medication contains less than 23 mg of sodium (1mmol) per 2 ml of injectable solution; this is, essentially "sodium-free".

This medication has been designed for hospital use.

During the administration of adenosine, continuous monitoring of the heart's function (electrocardiogram) is necessary since arrhythmia with life-threatening risk to the patient could occur. Heart rate and blood pressure must be continuously monitored.

It must be administered via rapid intravenous injection.

Newborns and children

Adenocor is a medication for use in hospitals equipped with resuscitation equipment.

Your doctor will decide if this medication is necessary, the amount to be administered based on your child's weight, and if multiple injections are required.

• Your child will be closely monitored, including a record of the electrical activity of their heart using an electrocardiogram (ECG).
• A doctor or nurse will administer it as an injection into your child's vein.

If you use more Adenocor than you should

No cases of overdose have been reported. The plasma half-life of adenosine is very short, and any side effects of this medication (if they occur) will resolve quickly upon discontinuation of administration.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

Like all medicines, this medicinemay cause side effects,although not everyone will experience them.

These side effects are related to the characteristics of adenosine and disappear within seconds or minutes of administration.

The observed side effects, by their frequency of presentation: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); unknown frequency (cannot be estimated from available data), have been:

Cardiac disorders:

Very frequent: facial flushing, bradycardia (low heart rate), sinus pause, absent heartbeats, atrial extrasystole, atrioventricular block, ventricular excitability alterations such as ventricular extrasystole, non-sustained ventricular tachycardia.

Infrequent: palpitations and sinus tachycardia.

Very rare: atrial fibrillation, severe bradycardia, ventricular fibrillation, and "torsades de pointes" (a type of arrhythmia, when the heart cannot pump enough oxygen-rich blood to the rest of the body, especially the brain).

Unknown frequency:asystole/cardiac arrest (sometimes fatal) and myocardial infarction/elevation of the ST segment. Coronary artery spasm that can cause a heart attack.

Nervous system disorders:

Frequent:headache, vertigo, dizziness.

Infrequent:intracranial hypertension.

Very rare:temporary and reversible worsening of intracranial hypertension.

Unknown frequency:syncope, fainting, and convulsions.

Eye disorders:

Infrequent:blurred vision.

Respiratory, thoracic, and mediastinal disorders:

Very frequent:difficulty breathing sensation.

Infrequent: hyperventilation.

Very rare:bronchospasm (contraction of the bronchial muscles),which can be fatal in some cases.

Unknown frequency:respiratory failure (sensation of suffocation,usually in patients with asthma or Chronic Obstructive Pulmonary Disease-COPD), apnea (lack of breathing)/cardiac arrest, which can be fatal in some cases.

Gastrointestinal disorders:

Frequent: nausea.

Infrequent: metallic taste.

Unknown frequency:vomiting.

Vascular disorders:

Very frequent:flushes.

Unknown frequency:hypotension (abnormal condition in which a person'sblood pressureis much lower than usual, which can causesymptomssuch asvertigoordizziness) sometimes severe.Transient ischemic attack (see Warnings and Precautions).

General disorders and administration site conditions:

Very frequent:chest pressure, sensation of thoracic oppression.Frequent:sensation of burning.

Infrequent:sweating and general feeling of discomfort/weakness/pain.

Very rare:reaction at the injection site.

Immune system disorders:

Unknown frequency: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

Mental and behavioral disorders:

Frequent: anxiety (fear).

Reporting of adverse reactions:

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

Keep this medication out of the sight and reach of children.

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

Do not refrigerate. Dispose of the remaining contents of a partially used vial.

Do not use this medication if particles or discoloration are observed.

Medications should not be thrown down the drain or in the trash.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition ofAdenocor

• The active principle is adenosine, at a concentration of 3 mg/ml of solution.
• The other components are sodium chloride (which correspond to 7.1 mg of sodium (0.3 mmol) of sodium per vial) and water for injectable preparations.

Aspect of the product and content of the package

Injectable solution, transparent and colorless

Each vial contains 6 mg of adenosine diluted in 2 ml of solution.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization:

Sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible for the manufacture:

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avenida de Leganés, 62

28925 Alcorcón (Madrid)

or

CENEXI HSC Hérouville-Saint-Clair

2, rue Louis Pasteur

14200 Hérouville-Saint-Clair (France)

Last review date of this leaflet: August 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

The following information is intended only for healthcare professionals:

Dosage and administration

This medicineshould only be used in a hospital setting where electrocardiographic monitoring and cardiopulmonary resuscitation are available.

Patients who, after a certain dose, present a high-degree atrioventricular block should not receive additional doses.

Dosage

• Therapeutic dose

-Adults:

• initial dose: 3 mg administered as a bolus intravenous injection (2-second injection)
• second dose: in the case of the first dose not stopping supraventricular tachycardia in 1 or 2 minutes, administer 6 mg as a bolus intravenous injection
• third dose: in the case of the second dose not stopping supraventricular tachycardia in 1 or 2 minutes, administer 12 mg in the same conditions.

No additional or higher doses are recommended.

-Pediatric population:

During the administration of adenosine, a cardiopulmonary resuscitation team should be available for immediate use if necessary.

Adenosine should be used with continuous electrocardiographic monitoring and recording during its administration.

The recommended dose in the pediatric population for the treatment of paroxysmal supraventricular tachycardia is:

-first bolus of 0.1 mg/kg of body weight (maximum dose of 6 mg)

- increments of 0.1 mg/kg of body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12 mg).

-65 years and older:

See recommended dosage for adults.

• Diagnostic dose

The ascending dosage indicated above may be administered to obtain sufficient diagnostic information.

Administration

Adenosine should be administered by rapid intravenous (IV) bolus, directly into a vein or through an intravenous catheter. If administered through an intravenous catheter, the injection should be made as close to the catheter as possible, followed by a rapid flush with physiological saline. If administered through a peripheral vein, a large-caliber cannula should be used.

Precautions to be taken before handling or administering the medication

The product should be visually inspected for color and absence of particles before administration.

Overdose

Overdose could cause severe hypotension, bradycardia, or asystole. The half-life of adenosine in the blood is very short (less than 10 seconds), and adverse effects are generally self-limited rapidly.

Individualized treatment should be directed at the specific symptom.

Methylxanthines, such as caffeine and theophylline, and aminophylline are competitive antagonists of adenosine.

Administration of aminophylline or theophylline may be necessary.