Adenocor

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Adenocor

3 mg/ml, solution for injection
Adenosine

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have 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 their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Adenocor and what is it 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 electrical impulses between the atria and ventricles (upper and lower chambers) of the heart. This slows down fast or irregular heartbeats called arrhythmia.

Indications for Use

• Rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia, including cases with an accessory 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 or fibrillation, or ventricular tachycardia, it can help assess atrial electrical activity by slowing conduction through 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 old.

2. Important Information Before Using Adenocor

When Not to Use Adenocor:

You should not take this medicine if you have any of the above conditions.
In case of doubt about their occurrence, you should consult a doctor before starting to use Adenocor.

Warnings and Precautions

Before starting to use Adenocor, you should consult a doctor if:

• the patient has a certain type of irregular heart rhythm (atrial flutter and fibrillation), in particular "accessory 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 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 pericarditis (inflammation of the membrane surrounding the heart) 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 the use of 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 heart rhythm disorder), Adenocor may cause severe heart rhythm disorders.

Adenocor and Other Medicines

You should 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, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• dipyridamole (a medicine used to thin the blood). You should inform your doctor if you are taking dipyridamole. The doctor will decide whether to discontinue Adenocor or stop taking dipyridamole for 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 for 24 hours before starting Adenocor;
• caffeine (sometimes used to treat headaches).

Adenocor with Food and Drink

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

Pregnancy and Breastfeeding

You should not take Adenocor if you are pregnant or breastfeeding, unless it is absolutely necessary. Therefore, before starting to use Adenocor, you should tell your doctor about pregnancy or breastfeeding.

Driving and Using Machines

This is not applicable.

Adenocor Contains Sodium

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 by intravenous injection or through a venous catheter. After administration through a venous catheter, the doctor or nurse will immediately flush the catheter with 0.9% sodium chloride solution.
• During the administration of Adenocor, the doctor or nurse will monitor the patient's heart function and blood pressure.

If you have any doubts or questions about using this medicine, you should 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 after administration, the catheter should be immediately flushed with physiological saline;
• second dose: if after the first dose the supraventricular tachycardia does not stop within 1 to 2 minutes, 6 mg should be administered in rapid intravenous injection, and after administration, the catheter should be immediately flushed with physiological saline;
• third dose: if after the second dose the supraventricular tachycardia does not stop within 1 to 2 minutes, 12 mg should be administered in rapid intravenous injection;
• it is not recommended to use subsequent doses or doses greater than 12 mg.

Elderly Patients:

The 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 additional injections of the medicine are needed.
During the administration of Adenocor, the patient will be constantly monitored, including electrocardiogram (ECG) recording.
Adenocor is administered intravenously by a doctor or nurse.
The 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);
• increasing by 0.1 mg/kg body weight as needed until the supraventricular tachycardia stops (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 Impairment

The efficacy of Adenocor is not affected in patients with renal or hepatic impairment.

Use of a Higher Than Recommended Dose of Adenocor

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 the event of an overdose, 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 the use of Adenocor.
Adenosine remains in the blood for a short period. Therefore, possible side effects that occur after administration of too much medicine will likely resolve quickly after discontinuation of Adenocor treatment. Intravenous administration of aminophylline or theophylline may be necessary.
If you suspect that you have used more than the recommended dose of Adenocor, you should immediately consult a doctor.
If you have any doubts about using this medicine, you should 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 the use of Adenocor.

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

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

• slow heart rate (bradycardia);
• atrial standstill;
• heart problem called atrioventricular block;
• additional atrial contractions;
• ventricular excitability disorders, 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, supraventricular tachycardia;
• metallic taste in the mouth;
• more frequent and deeper breathing than usual (hyperventilation);
• feeling of pressure in the head or 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 shortness of breath 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 flutter, 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;
• 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, you should tell your doctor or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to Store Adenocor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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, Adenocor should not be used.
If the appearance of the medicine has changed, the vial should be discarded.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Adenocor Contains:

• The active substance of Adenocor 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 Packs:

6 vials of 2 ml
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in the Czech Republic, the Country of Export:

sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Praha 6 - Vokovice
Czech Republic

Manufacturer:

Famar Healthcare services Madrid, S.A.U.
Alcorcón (Madrid)
Spain
Cenexi HSC
2 rue Louis Pasteur
14200 Herouville-Saint-Clair
France

Parallel Importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 13/574/95-C

Parallel Import Authorization Number: 371/15 Date of approval of the leaflet: 17.05.2023

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