Adenocor

Leaflet accompanying the packaging: information for the user

ADENOCOR

3 mg/ml, solution for injection
Adenosine

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Adenocor is and what it is used for
• 2. Important information before using Adenocor
• 3. How to use Adenocor
• 4. Possible side effects
• 5. How to store Adenocor
• 6. Package contents and other information

1. What Adenocor is and what it is used for

Adenosine is a purine nucleoside found in all cells of the body. It belongs to the group of anti-arrhythmic drugs. Adenocor works by slowing down the electrical impulses between the atria and ventricles (upper and lower chambers) of the heart. This slows down rapid or irregular heartbeats called arrhythmia.

Indications for use

• Rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia, also in cases with an additional conduction pathway (Wolff-Parkinson-White syndrome).
• Aid in the differential diagnosis of supraventricular tachycardia with wide or narrow QRS complexes. Although adenosine is not effective in treating atrial flutter, atrial fibrillation, or ventricular tachycardia, it does facilitate the evaluation of atrial electrical activity by slowing down conduction in the atrioventricular node.

Children and adolescents

• Rapid restoration of normal heart rhythm in paroxysmal supraventricular tachycardia in children and adolescents from 0 to 18 years of age.

2. Important information before using Adenocor

When not to use Adenocor:

• if the patient is allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, or difficulty breathing, swelling of the lips, face, throat, or tongue.
• if the patient has chronic obstructive pulmonary disease with symptoms of bronchospasm - difficulty breathing (e.g., asthma).
• if the patient has very low blood pressure (severe hypotension).
• if the patient has a certain type of heart failure, in which the heart is unable to pump enough blood.
• if the patient has arrhythmias except for patients with a pacemaker (second- or third-degree atrioventricular block, sick sinus syndrome).
• if the patient has a long QT syndrome. This is a rare heart disorder that can lead to rapid heartbeat and fainting.

Do not take this medicine if you have any of the above conditions. If in doubt about their occurrence, consult a doctor before starting treatment with Adenocor.

Warnings and precautions

Before starting treatment with Adenocor, discuss with your doctor if:

• the patient has a certain type of irregular heart rhythm (atrial flutter and atrial fibrillation), particularly "additional conduction pathway"
• the patient has heart disease characterized by prolonged electrical impulses in the heart (prolonged QT interval)
• the patient has low blood volume (hypovolemia) that is not corrected by appropriate treatment
• the patient has problems with the part of the nervous system called the autonomic nervous system
• the patient has carotid artery stenosis. This means that too little blood reaches the brain (cerebrovascular insufficiency)
• the patient has had or currently has seizures or convulsions
• the patient has chronic obstructive pulmonary disease
• the patient has heart disease caused by narrowing of the heart valves
• the patient has inflammation of the membrane surrounding the heart (pericarditis) or fluid accumulation around the heart (pericardial effusion)
• the patient has a left-to-right heart shunt. This means that blood flows directly from the left side of the heart to the right
• the patient has narrowing of the left main coronary artery supplying blood to the heart
• the patient has had a recent heart attack, severe heart failure, or heart transplant in the last year
• the patient has minor heart problems (first-degree atrioventricular block or bundle branch block). The symptoms of these diseases may temporarily worsen during treatment with Adenocor.
• the patient is taking dipyridamole (see below). If the patient has very slow heart rate (severe bradycardia), respiratory failure, life-threatening heart problems (asystole), severe chest pain (angina pectoris), or very low blood pressure (severe hypotension), Adenocor treatment should be discontinued immediately.

Children and adolescents

In children with Wolff-Parkinson-White syndrome (WPW; a condition characterized by arrhythmia), Adenocor may cause severe arrhythmias.

Adenocor and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription, including herbal preparations.
Adenocor and other medicines used at the same time may affect each other's action.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• dipyridamole (a medicine used to thin the blood). Inform your doctor if you are taking dipyridamole. The doctor will decide whether to discontinue Adenocor or stop taking dipyridamole 24 hours before starting Adenocor and reduce the dose of Adenocor.
• aminophylline or theophylline (medicines used to improve breathing). The doctor will decide to discontinue these medicines 24 hours before starting Adenocor.
• caffeine (sometimes used to treat headaches).

Adenocor with food and drink

Do not consume foods and drinks containing caffeine, such as coffee, tea, chocolate, and cola, for 12 hours before administering Adenocor.

Pregnancy and breastfeeding

Do not take Adenocor if you are pregnant or breastfeeding, unless it is absolutely necessary. Therefore, before starting treatment with Adenocor, tell your doctor if you are pregnant or breastfeeding.

Driving and operating machinery

This is not applicable.

Adenocor contains sodium

Adenocor contains 3.54 mg of sodium in 1 ml (in the form of 9 mg of sodium chloride in 1 ml).
This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.
The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Adenocor

• Adenocor is intended for use in a hospital setting with the possibility of immediate use of cardiopulmonary resuscitation equipment.
• Adenocor is intended for administration by a doctor or nurse via intravenous or intravenous catheter injection. After administration via an intravenous catheter, the doctor or nurse will immediately flush the catheter with 0.9% sodium chloride solution.
• During administration of Adenocor, the doctor or nurse will monitor the patient's heart function and blood pressure.

In case of any further doubts or questions related to the use of this medicine, consult a doctor or nurse.

Dosing for rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia

Adults (including elderly patients):

• initial dose: 3 mg in rapid intravenous injection (within 2 seconds), and then immediately flush the catheter with physiological saline;
• second dose: if paroxysmal supraventricular tachycardia does not resolve within 1 to 2 minutes after the first dose, administer 6 mg also in rapid intravenous injection, and then immediately flush the catheter with physiological saline;
• third dose: if paroxysmal supraventricular tachycardia does not resolve within 1 to 2 minutes after the second dose, administer 12 mg also in rapid intravenous injection.
• do not recommend further doses or doses greater than 12 mg.

Elderly patients:

Recommended dosing is the same as for adults.

Use in children and adolescents:

Adenocor is intended for use in hospitals where cardiopulmonary resuscitation equipment is available. The decision to use the medicine and the dose administered is made by a doctor based on the child's body weight. The doctor will also decide if further injections of the medicine are needed.
During administration of Adenocor, the patient will be constantly monitored, including electrocardiogram (ECG) recording.
Adenocor is administered intravenously by a doctor or nurse.
Recommended dosing for the treatment of paroxysmal supraventricular tachycardia in children and adolescents:

• first bolus 0.1 mg/kg body weight (maximum dose 6 mg)
• increase by 0.1 mg/kg body weight as needed, until paroxysmal supraventricular tachycardia resolves (maximum dose 12 mg).

Dosing used in the differential diagnosis of supraventricular tachycardia

The above dosing scheme will be used by the doctor until sufficient data is obtained to determine the type of arrhythmia the patient has.

Use in children and adolescents:

Currently available data does not support the use of adenosine in children and adolescents for diagnostic purposes.

Patients with liver and/or kidney function disorders

The efficacy of Adenocor is not affected in cases of renal or hepatic insufficiency.

Use of a higher dose of Adenocor than recommended

It is unlikely that a patient will take too much Adenocor, as the medicine is administered by a doctor or nurse.
The doctor will carefully assess the dose of the medicine to be administered to the patient.
In case of administration of a higher dose of the medicine than recommended, the following side effects may occur:

• very low blood pressure (severe hypotension)
• slow heart rate (bradycardia)
• heart problem (asystole). The doctor will monitor the patient's heart function during treatment. Adenosine stays in the blood for a short period. Therefore, possible side effects that occur after administration of too high a dose of the medicine will probably resolve quickly after discontinuation of Adenocor treatment. Intravenous administration of aminophylline or theophylline may be necessary.

In case of suspected administration of a higher dose of the medicine than recommended, consult a doctor immediately.
In case of any further doubts related to the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Adenocor can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Adenocor.

If any of the following side effects worsen, inform your doctor or nurse, as it may be necessary to discontinue treatment:

Side effects usually resolve within a few seconds or minutes after the end of the injection, but inform your doctor or nurse if any of them occur.
Very common (affect more than 1 in 10 patients)

• slow heart rate (bradycardia)
• SA node inhibition
• heart problem called atrioventricular block
• additional atrial contractions
• ventricular arrhythmias, such as: additional ventricular contractions, ventricular tachycardia
• feeling of irregular heartbeat
• shortness of breath or dyspnea
• chest pain and/or feeling of pressure, squeezing in the chest
• flushing of the face with a feeling of heat, Common (affect less than 1 in 10 patients)
• dizziness or feeling of emptiness in the head
• headache
• nausea
• feeling of burning
• anxiety Uncommon (affect less than 1 in 100 patients)
• feeling of pressure in the head
• blurred vision
• palpitations, sinus tachycardia
• metallic taste in the mouth
• faster and deeper breathing than usual (hyperventilation)
• feeling of heaviness in the arms
• feeling of general discomfort, weakness, and pain
• excessive sweating

Rare (affect less than 1 in 10,000 patients)

• severe dyspnea and breathing difficulties due to bronchospasm
• redness, pain, or itching at the injection site
• increased intracranial pressure
• severe bradycardia (slow heart rate)
• life-threatening irregular heartbeat (torsade de pointes - ventricular arrhythmia)
• ventricular fibrillation, atrial fibrillation Frequency not known (cannot be estimated from the available data)
• loss of consciousness
• fainting
• seizures, especially in people with a history of seizures
• hypotension
• lack of ventricular contractions
• cardiac arrest (asystole), sometimes with a fatal outcome, especially in patients with concomitant coronary artery disease or other heart diseases
• myocardial infarction
• coronary artery spasm, which can lead to myocardial infarction
• stroke or transient cerebral ischemic attack
• vomiting
• respiratory failure
• apnea and/or respiratory arrest
• anaphylactic reaction (angioedema characterized by swelling of the lips, face, tongue, or throat, and difficulty breathing and swallowing; urticaria; rash)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Adenocor

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Do not freeze.
The medicine is intended for single use only and should be used immediately after opening.
Any unused contents of the vial should be discarded after opening.
If the doctor or nurse observes any particles in the solution or discoloration before administration, do not use Adenocor.
If the appearance of the medicine has changed, discard the vial.
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. Package contents and other information

What Adenocor contains:

• The active substance of the medicine is adenosine. One ml of the solution for injection contains 3 mg of adenosine.
• The other ingredients are: sodium chloride, water for injections. One vial of 2 ml contains 6 mg of adenosine.

Available packages:

6 vials of 2 ml

Marketing authorization holder:

Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France

Manufacturer:

FAMAR HEALTHCARE SERVICES MADRID, S.A.U.
Avenida le Leganés, 62
28923 Alcorcón (Madrid)
Spain
CENEXI HSC
Hérouville-Saint-Clair
2 rue Louis Pasteur,
14200 HEROUVILLESAINT-CLAIR
France
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00

Date of last revision of the leaflet: