ADENOCOR 6 mg/2 ml INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

Adenocor 6 mg/2 ml solution for injection

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

5 Storage of Adenocor

1. Contents of the pack and further information

1. What is Adenocor and what is it used for

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

This medicine is used for the diagnosis and treatment of certain heart rhythm disorders.

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).

2. What you need to know before you use Adenocor

Do not use Adenocor

• If you are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6).
• If you have certain heart problems such as sick sinus syndrome, certain atrioventricular blocks (except in patients with a functioning artificial pacemaker); or heart failure.
• If you have a condition called QT interval prolongation which is an abnormality of the heart's electrical system that can cause an abnormal heart rhythm (arrhythmia), fainting or loss of consciousness (syncope) and even sudden death.
• If you have severe hypotension, a condition where your blood pressure is much lower than usual, which can cause symptoms such as dizziness or lightheadedness.

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

Warnings and precautions

Consult your doctor before starting to use Adenocor:

• If you have certain 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 worsen 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 usually 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 abnormal pathway.
• In case of left coronary artery stenosis, valvular stenosis, uncorrected hypovolemia (decrease in circulating blood volume), pericarditis (inflammation of the membrane that surrounds the heart, pericardium) or pericardial effusion, autonomic dysfunction or carotid artery stenosis with cerebrovascular insufficiency.
• If you are taking dipyridamole (a medicine for the treatment of blood coagulation problems).

In patients with recent heart transplant (less than 1 year), an increased sensitivity of the heart 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 can cause abnormal heart rhythm unexpectedly.

Using Adenocor with other medicines

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

The administration of adenosine with other medicines may modify their effects. Tell your doctor or pharmacist if you are taking:

• dipyridamole (a medicine for the treatment of blood coagulation problems).
• aminophylline, theophylline, or other xanthines (medicines for the treatment of asthma or bronchitis). These medicines should not be taken in the 24 hours prior to the administration of this medicine.

Using Adenocor with food and drinks

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.

This medicine should not be used during breastfeeding, as it is not known whether it passes into breast milk. If your doctor considers that treatment with adenosine is essential, you should consider an alternative method of feeding your child.

Adenocor contains sodium

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

3. How to use Adenocor

This medicine is designed for hospital use.

During the administration of adenosine, continuous monitoring of heart function (electrocardiogram) is necessary, as it may cause a life-threatening arrhythmia. Heart rate and blood pressure should be continuously monitored.

It should be administered by rapid intravenous injection.

Infants and children

Adenocor is a medicine for use in hospitals that have resuscitation equipment.

Your doctor will decide if it is necessary to use this medicine, what dose should be administered depending on your child's weight, and if multiple injections are needed.

• Your child will be closely monitored, including a recording of the electrical activity of the 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 (if they occur) will resolve very quickly after discontinuation of the medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The side effects observed, according to their frequency of presentation: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from the available data), have been:

Cardiac disorders:

Very common: facial flushing, bradycardia (slow heart rate), sinus pause, absent beats, atrial extrasystoles, atrioventricular block, alterations in ventricular excitability such as ventricular extrasystoles, non-sustained ventricular tachycardia.

Uncommon: palpitations and sinus tachycardia.

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

Frequency not known: asystole/cardiac arrest (sometimes fatal) and myocardial infarction/ST segment elevation. Coronary artery spasm that can cause a heart attack.

Nervous system disorders:

Common: headache, dizziness, lightheadedness.

Uncommon: increased intracranial pressure.

Very rare: temporary and reversible worsening of intracranial hypertension.

Frequency not known: fainting, syncope, and seizures.

Eye disorders:

Uncommon: blurred vision.

Respiratory, thoracic, and mediastinal disorders:

Very common: sensation of difficulty breathing.

Uncommon: hyperventilation.

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

Frequency not known: respiratory failure (feeling of suffocation, usually in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD)), apnea (lack of breathing)/respiratory arrest, which can be fatal in some cases.

Gastrointestinal disorders:

Common: nausea.

Uncommon: metallic taste.

Frequency not known: vomiting.

Vascular disorders:

Very common: flushing.

Frequency not known: hypotension (a condition where your blood pressure is much lower than usual, which can cause symptoms such as dizziness or lightheadedness), sometimes severe. Cerebrovascular accident/transient ischemic attack (see section Warnings and precautions).

General disorders and administration site conditions:

Very common: chest pressure/pain, sensation of chest oppression.

Common: sensation of burning.

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

Very rare: reactions at the injection site.

Immune system disorders:

Frequency not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

Psychiatric disorders:

Common: apprehension (fear).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adenocor

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 carton after EXP. The expiry date is the last day of the month shown.

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

Do not use this medicine if you notice particles or coloration.

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.

6. Contents of the pack and further information

Composition of Adenocor

• The active substance is adenosine, at a concentration of 3 mg/ml of solution.
• The other ingredients are sodium chloride (which corresponds to 7.1 mg of sodium (0.3 mmol) per vial) and water for injections.

Appearance and pack contents

Clear and colorless solution for injection

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

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)

Date of last revision of this leaflet: August 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.

The following information is intended only for healthcare professionals:

Posology and method of administration

This medicine should only be used in a hospital setting where electrophysiological monitoring and cardiorespiratory resuscitation are possible.

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

Posology

• Therapeutic dose

• Adults:
  • initial dose: 3 mg administered as an intravenous bolus (2-second injection)
  • second dose: if the first dose does not stop the supraventricular tachycardia within 1 or 2 minutes, administer 6 mg as an intravenous bolus
  • third dose: if the second dose does not stop the supraventricular tachycardia within 1 or 2 minutes, administer 12 mg under the same conditions.

Higher or additional doses are not recommended.

• Pediatric population:

During the administration of adenosine, a cardio-respiratory resuscitation team must be available for immediate use if necessary.

Adenosine must 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 body weight (maximum dose of 6 mg)
• increases of 0.1 mg/kg body weight as needed until the supraventricular tachycardia is terminated (maximum dose of 12 mg).

• Over 65 years:

See recommended posology in adults.

• Diagnostic dose

The ascending posology indicated above may be administered until sufficient diagnostic information is obtained.

Method of administration

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

Precautions to be taken before handling or administering the medicine

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

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 the side effects are generally self-limiting and resolve quickly.

Treatment of any prolonged side effects should be individualized and 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.