Adenocor

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Adenocor
3 mg/ml, solution for injection
Adenosinum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of contents:

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. Contents of the pack and other information

1. What Adenocor is and what it is used for

Adenosine is a purine nucleoside present in all cells of the body.
It belongs to the group of antiarrhythmic drugs. Adenocor works by slowing down electrical impulses between the atria and ventricles (upper and lower chambers) of the heart. This slows down rapid or irregular heartbeat known as arrhythmia.
Indications

• Rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia, including cases involving an accessory conduction pathway (Wolff-Parkinson-White syndrome).
• Aid in differential diagnosis of supraventricular tachycardia with either broad or narrow QRS complexes. Although adenosine is not effective in treating atrial flutter, atrial fibrillation, or ventricular tachycardia, slowing conduction through the atrioventricular node facilitates assessment of atrial electrical activity.

Children and adolescents

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

2. Important information before using Adenocor

When not to use Adenocor:

• if the patient is allergic (hypersensitive) to adenosine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, breathing difficulties, or swelling of the lips, face, throat or tongue.
• if the patient has chronic obstructive pulmonary disease with bronchospasm symptoms – breathing difficulties (e.g. bronchial 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 sufficient blood.
• if the patient has heart rhythm disorders, except in patients with a pacemaker (second- and third-degree atrioventricular block, sick sinus syndrome).
• if the patient has long QT syndrome. This is a rare heart disorder which may lead to rapid heartbeat and fainting.

Do not take this medicine if any of the above conditions apply to the patient.
If in doubt about the presence of any of these conditions, consult a doctor before
starting treatment with Adenocor.
Warnings and precautions
Before starting treatment with Adenocor, consult a doctor if:

• the patient has a certain type of irregular heartbeat (atrial fibrillation and flutter), particularly with an "accessory conduction pathway";
• the patient has a heart condition in which electrical impulses in the heart responsible for depolarization and repolarization (discharge and recharge) last longer than usual (prolonged QT interval);
• the patient has low blood volume (hypovolemia) that has not been corrected by appropriate treatment;
• the patient has problems with the part of the nervous system called the autonomic nervous system;
• the patient has narrowing of the carotid artery. This means insufficient blood supply to the brain (cerebral vascular insufficiency);
• the patient has ever had seizures or convulsions;
• the patient has chronic obstructive pulmonary disease;
• the patient has heart disease caused by narrowing of heart valves;
• the patient has inflammation of the membrane surrounding the heart (pericarditis) or fluid accumulation around the heart (pericardial effusion);
• the patient has left-to-right cardiac shunt. This means 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 recently suffered a myocardial infarction, severe heart failure, or heart transplantation within the past year;
• the patient has minor heart problems (first-degree atrioventricular block or bundle branch block). Symptoms of these conditions 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), treatment with Adenocor must be stopped immediately.
Children and adolescents
In children with Wolff-Parkinson-White syndrome (WPW; a condition characterized by heart rhythm disturbances), Adenocor may cause severe heart rhythm disorders.
Adenocor and other medicines
Tell your doctor about all medicines currently taken or recently taken, including those obtained without a prescription, as well as herbal preparations. Adenocor and other medicines taken simultaneously may interact and affect each other's action.
In particular, inform your doctor or pharmacist if the patient is taking any of
the following medicines:

• dipyridamole (a medicine used to thin the blood). Inform the doctor if dipyridamole is being taken. The doctor will decide either not to administer Adenocor or to discontinue dipyridamole 24 hours before starting Adenocor and to 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 in headache treatment).

Adenocor with food and drink
Do not consume food or beverages containing caffeine (e.g. coffee, tea, chocolate, cola) for 12 hours before administration of Adenocor.
Pregnancy and breastfeeding
Do not take Adenocor if the patient is pregnant (or suspects she may be pregnant) or is breastfeeding, unless absolutely necessary. Therefore, inform the doctor about pregnancy or breastfeeding before starting treatment with Adenocor.
Driving and operating machinery
Not applicable.
Adenocor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".

3. How to use Adenocor

• Adenocor is intended for use in hospital settings with immediate access to resuscitation equipment.
• Adenocor is administered by a doctor or nurse as an intravenous injection or via an intravenous line. After administration via an intravenous line, the doctor or nurse will immediately flush the line with 0.9% sodium chloride solution.
• During administration of Adenocor, the doctor or nurse will monitor heart function and arterial blood pressure.

If you have any doubts or questions about how to use this medicine, consult your doctor or nurse.

Dosage for rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia

Adults (including elderly patients):

• Initial dose: 3 mg as a rapid intravenous injection (over 2 seconds), immediately followed by flushing the line with physiological saline;
• Second dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the first dose, administer 6 mg as a rapid intravenous injection, immediately followed by flushing the line with physiological saline;
• Third dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the second dose, administer 12 mg as a rapid intravenous injection;
• Further doses or doses exceeding 12 mg are not recommended.

Elderly patients:
Recommended dosage as in adults.

Use in children and adolescents:
Adenocor is intended for use in hospitals where resuscitation equipment must be available. The decision on using the medicine and the dose to be administered is made by the doctor based on the child's body weight. The doctor will also decide whether further injections are necessary.
During administration of Adenocor, the patient will be continuously monitored, including continuous electrocardiographic (ECG) recording.
Adenocor is administered intravenously by a doctor or nurse.

Recommended dosage for treatment of paroxysmal supraventricular tachycardia in children and adolescents:

• First bolus: 0.1 mg/kg body weight (maximum dose 6 mg);
• Increments of 0.1 mg/kg body weight as needed until termination of supraventricular tachycardia (maximum dose 12 mg).

Dosage used in differential diagnosis of supraventricular tachycardia
The above dosing regimen may be used by the doctor until sufficient data are obtained to determine the type of arrhythmia the patient has.

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

Patients with hepatic and/or renal impairment
The efficacy of Adenocor is not altered in cases of renal or hepatic insufficiency.

Administration of a higher than recommended dose of Adenocor
It is unlikely that a patient would receive an overdose of Adenocor, as the medicine is administered by a doctor or nurse.
The doctor will carefully assess the appropriate dose for the patient.
If a higher than recommended dose is administered, the following adverse effects may occur:

• very low blood pressure (severe hypotension);
• slowed heart rate (bradycardia);
• heart problem (asystole).

The doctor will monitor heart function during treatment with the medicine.
Adenosine remains in the blood for a short period of time. Therefore, any adverse effects following an overdose are likely to resolve quickly after discontinuation of Adenocor. Intravenous administration of aminophylline or theophylline may be necessary.
In case of suspected overdose, seek immediate medical advice.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Adenocor.
If any of the following adverse reactions worsen, inform your
doctor or nurse, as it may be necessary to discontinue the medicine:
Adverse reactions usually resolve within a few seconds or minutes after the injection has ended, but you should inform your doctor or nurse if any of them occur.

Very common (affects more than 1 in 10 patients)

• Slowed heart rate (bradycardia);
• Sinus arrest;
• Heart problem known as atrioventricular block;
• Extra atrial contractions;
• Ventricular arrhythmias, such as: ventricular extrasystoles, ventricular tachycardia;
• Sensation of irregular heartbeat;
• Shortness of breath or dyspnoea;
• Pain and/or pressure or squeezing sensation in the chest;
• Facial flushing with a feeling of warmth.

Common (affects less than 1 in 10 patients)

• Dizziness or feeling faint;
• Headache;
• Nausea;
• Burning sensation;
• Anxiety.

Uncommon (affects less than 1 in 100 patients)

• Head pressure sensation;
• Blurred vision;
• Palpitations, sinus tachycardia;
• Metallic taste in the mouth;
• Faster and deeper breathing than usual (hyperventilation);
• Head pressure or heaviness in arms;
• General discomfort, weakness and pain;
• Excessive sweating.

Very rare (affects 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 (slowed heart rate);
• Life-threatening irregular heartbeat (torsade de pointes – ventricular arrhythmia);
• Ventricular fibrillation, atrial fibrillation.

Frequency not known (cannot be estimated from available data)

• Loss of consciousness;
• Fainting;
• Seizures, particularly in patients with a predisposition to seizures;
• Hypotension;
• Absence of ventricular contractions;
• Cardiac arrest (asystole), sometimes fatal, particularly in patients with concomitant ischaemic heart disease or other heart conditions;
• Myocardial infarction;
• Stroke or transient ischaemic attack;
• Vomiting;
• Respiratory failure;
• Apnoea and/or respiratory arrest;
• Anaphylactic reaction (angioedema manifested by swelling of lips, face, tongue or throat, and difficulty breathing or swallowing; urticaria; rash).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adenocor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not freeze.
This medicine is intended for single use only and should be used immediately after opening.
Any unused portion of the vial contents after opening must be discarded.
If the doctor or nurse observes any particles in the solution or discoloration before injection, Adenocor must not be used.
If the appearance of the medicine has changed, the vial should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Adenocor contains:

• The active substance is adenosine. One ml of injection solution contains 3 mg of adenosine.
• The other components are: sodium chloride, water for injections.

One 2 ml vial contains 6 mg of adenosine.
Available pack sizes:
6 vials of 2 ml
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, the country of export: 13/574/95-C
Parallel import authorisation number: 371/15