Adenocor

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Adenocor, 3 mg/ml, solution for injection
Adenosine
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet contents:

1. What Adenocor is and what it is used for
2. What you need to know 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 heartbeats 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 the 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). Allergic reactions 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 for patients with an implanted cardiac pacemaker (second- and third-degree atrioventricular block, sick sinus syndrome);
• if the patient has long QT syndrome. This is a rare heart condition that may lead to rapid heartbeat and fainting.

This medicine should not be used if any of the above conditions apply. If in doubt about their presence, 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 a part of the heart take longer than normal to depolarize and then repolarize (recharge and discharge) (prolonged QT interval);
• the patient has low blood volume (hypovolemia) not corrected by appropriate treatment;
• the patient has problems with a part of the nervous system called the autonomic nervous system;
• the patient has narrowing of the carotid artery. This means insufficient blood flow to the brain (cerebral vascular insufficiency);
• the patient has had seizures or convulsions in the past or currently;
• 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 a 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 heart attack, severe heart failure, or received a heart transplant within the past year;
• the patient has minor heart problems (first-degree atrioventricular block or bundle branch block). Symptoms of these conditions may transiently 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 (WPW) syndrome (a condition characterized by abnormal heart rhythm), Adenocor may cause severe heart rhythm disturbances.

Adenocor and other medicines

Inform the doctor about all medicines currently used or recently taken, including those available without prescription, as well as herbal preparations. Adenocor and other medicines taken simultaneously may interact and affect each other's actions.

In particular, inform the 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 used. The doctor will decide either not to use Adenocor or to discontinue dipyridamole 24 hours before starting Adenocor and reduce the Adenocor dose;
• 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 drinks 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 pregnancy, or is breastfeeding, unless absolutely necessary. Therefore, inform the doctor about pregnancy or breastfeeding before starting treatment with Adenocor.

Driving and using machines

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 cardiopulmonary resuscitation equipment.
• Adenocor is intended to be administered by a doctor or nurse as an intravenous injection or via an intravenous catheter. 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 heart function and blood pressure.

If you have any doubts or questions about using 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 administered as a rapid intravenous injection (within 2 seconds), followed immediately by flushing the catheter with saline;
• second dose: if supraventricular tachycardia has not resolved within 1 to 2 minutes after the first dose, administer 6 mg as a rapid intravenous injection, followed immediately by flushing the catheter with saline;
• third dose: if supraventricular tachycardia has not resolved 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 for adults.

Use in children and adolescents

Adenocor is intended for use in hospitals where cardiopulmonary resuscitation equipment is available. The decision on using the medicine and the dose administered is made by the doctor based on the child's body weight. The doctor will also decide whether additional injections are needed.

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:

• initial bolus: 0.1 mg/kg body weight (maximum dose 6 mg);
• increase by 0.1 mg/kg body weight as needed until supraventricular tachycardia resolves (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 in children and adolescents for diagnostic purposes.

Patients with impaired liver and/or kidney function

The efficacy of Adenocor is not altered in cases of renal or hepatic impairment.

Use of a higher than recommended dose of Adenocor

It is unlikely that a patient would receive an excessive dose, as Adenocor 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 problems (asystole).

The doctor will monitor heart function during treatment. Adenosine remains in the bloodstream only briefly. Therefore, any adverse effects following an excessive dose are likely to resolve quickly after stopping Adenocor. Intravenous administration of aminophylline or theophylline may be necessary.

If an overdose is suspected, seek immediate medical advice.

If you have any doubts about using 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 is completed,
but you should inform your doctor or nurse if any of them occur.

Very common (affecting more than 1 in 10 patients)

• Slowed heart function (bradycardia)
• Sinus arrest
• A heart problem called atrioventricular block
• Extra atrial contractions
• Ventricular excitability disturbances, such as: extra ventricular contractions, ventricular tachycardia
• Sensation of irregular heartbeat
• Shortness of breath or dyspnea
• Chest pain and/or pressure, crushing sensation in the chest
• Facial flushing with sensation of warmth

Common (affecting less than 1 in 10 patients)

• Dizziness or feeling of emptiness in the head
• Headache
• Nausea
• Burning sensation
• Anxiety

Uncommon (affecting less than 1 in 100 patients)

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

Rare (affecting 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 function)
• Life-threatening irregular heartbeat (torsade de pointes – a 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 ischemic heart disease or other heart conditions
• Myocardial infarction
• Stroke or transient ischemic attack
• Vomiting
• Respiratory failure
• Apnea 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,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 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 or discoloration in the solution prior to injection, Adenocor must not be used.
If the appearance of the medicine has changed, the vial must be discarded.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Adenocor contains:

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

One 2 ml vial contains 6 mg of adenosine.
Available pack sizes:
6 vials of 2 ml in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
sanofi-aventis, s.r.o., Evropská 846/176a, 160 00 Prague 6, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, country of export: 13/574/95-C
Parallel Import Licence Number: 293/19