Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Adenosinum Inpharm, 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, 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. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

What Adenosinum Inpharm is and what it is used for
Important information before using Adenosinum Inpharm
How to use Adenosinum Inpharm
Possible side effects
How to store Adenosinum Inpharm
Contents of the pack and other information

1. What Adenosinum Inpharm 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. Adenosinum Inpharm 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 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, transient slowing of 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 Adenosinum Inpharm

When not to use Adenosinum Inpharm:

if the patient is allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include 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 cardiac pacemaker (second- or 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.

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 Adenosinum Inpharm.
Warnings and precautions
Before starting treatment with Adenosinum Inpharm, discuss with your doctor if:

the patient has a certain type of irregular heartbeat (atrial fibrillation or 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 usual to depolarize and then repolarize (prolonged QT interval);
the patient has low blood volume (hypovolemia) that has not been corrected by appropriate treatment;
the patient has problems with part of the nervous system called the autonomic nervous system;
the patient has narrowing of the carotid artery, meaning insufficient blood flow to 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 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, meaning 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 had a myocardial infarction, severe heart failure, or heart transplantation within the past year;
the patient has minor heart conduction problems (first-degree atrioventricular block or bundle branch block). Symptoms of these conditions may temporarily worsen during treatment with Adenosinum Inpharm.
the patient is taking dipyridamole (see below).

If the patient develops 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 Adenosinum Inpharm must be stopped immediately.
Children and adolescents
In children with Wolff-Parkinson-White (WPW) syndrome (a condition characterized by abnormal heart rhythm), Adenosinum Inpharm may cause severe heart rhythm disturbances.
Adenosinum Inpharm and other medicines
Tell your doctor about all medicines currently or recently taken, including those obtained without a prescription, as well as herbal preparations. Adenosinum Inpharm and other medicines taken concurrently may affect each other's actions.
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 your doctor if dipyridamole is being used. The doctor will decide either not to use Adenosinum Inpharm or to discontinue dipyridamole 24 hours before starting Adenosinum Inpharm and to reduce the dose of Adenosinum Inpharm;
aminophylline or theophylline (medicines used to improve breathing). The doctor will decide to discontinue these medicines 24 hours before starting Adenosinum Inpharm;
caffeine (sometimes used in headache treatment).

Adenosinum Inpharm with food and drink
Do not consume foods or beverages containing caffeine (e.g. coffee, tea, chocolate, cola) for 12 hours before administration of Adenosinum Inpharm.
Pregnancy and breastfeeding
Do not take Adenosinum Inpharm if the patient is pregnant or suspects she may be pregnant, or is breastfeeding, unless absolutely necessary. Therefore, inform your doctor if you are pregnant or breastfeeding before starting treatment with Adenosinum Inpharm.
Driving and using machines
Not applicable.
Adenosinum Inpharm contains sodium
Adenosinum Inpharm contains 3.54 mg of sodium per 1 ml (in the form of 9 mg of sodium chloride per 1 ml). This should be taken into account in patients with impaired kidney function and in patients on a sodium-controlled diet.
The medicine contains less than 1 mmol (23 mg) of sodium per vial; therefore, the medicine is considered "sodium-free".

3. How to use Adenosinum Inpharm

Adenosinum Inpharm is intended for use in a hospital setting with immediate access to equipment for cardiopulmonary resuscitation.
Adenosinum Inpharm is intended to be administered by a physician or nurse as an intravenous injection or via a venous catheter. After administration via a venous catheter, the physician or nurse will immediately flush the catheter with 0.9% sodium chloride solution.
During administration of Adenosinum Inpharm, the physician or nurse will monitor heart function and arterial blood pressure.

If you have any further questions or uncertainties regarding the use of this medicine, please
consult your physician 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 physiological saline;
second dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the first dose, administer 6 mg also as a rapid intravenous injection, followed immediately by flushing the catheter with physiological saline;
third dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the second dose, administer 12 mg also as a rapid intravenous injection;
further doses or doses exceeding 12 mg are not recommended.

Elderly patients:
Recommended dosage is the same as for adults.
Use in children and adolescents:
Adenosinum Inpharm is intended for use in hospitals where cardiopulmonary resuscitation equipment must be available. The decision on whether to use the medicine and the dosage to be administered is made by the physician based on the child's body weight. The physician will also decide whether additional injections of the medicine are needed.
During administration of Adenosinum Inpharm, the patient will be continuously monitored, including continuous recording of the heart's electrical activity (ECG).
Adenosinum Inpharm is administered intravenously by a physician or nurse.
Recommended dosage for the 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, up to cessation of supraventricular tachycardia (maximum dose 12 mg).

Dosage used in differential diagnosis of supraventricular tachycardia
The physician will use the above dosing regimen until sufficient data are obtained to determine the type of arrhythmia the patient has.
Use in children and adolescents:
Currently available data do not confirm the appropriateness of using adenosine in children and adolescents for diagnostic purposes.
Patients with hepatic and/or renal impairment
The efficacy of Adenosinum Inpharm is not altered in cases of renal or hepatic insufficiency.
Administration of a higher than recommended dose of Adenosinum Inpharm
It is highly unlikely that a patient would receive an excessive dose, as Adenosinum Inpharm is administered by a physician or nurse.
The physician 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 physician will monitor heart function during treatment.
Adenosine remains in the blood for a short time. Therefore, any adverse effects following an excessive dose are likely to resolve quickly after discontinuation of Adenosinum Inpharm. Intravenous administration of aminophylline or theophylline may be necessary.
If a higher than recommended dose is suspected, seek immediate medical attention from a physician.
If you have any further questions or uncertainties regarding the use of this medicine, please consult your physician.

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 Adenosinum Inpharm.
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 (affect more than 1 in 10 patients)

Slowing of the heart rate (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
Pain and/or pressure, squeezing in the chest
Facial flushing with a sensation of warmth.

Common (affect less than 1 in 10 patients)

Dizziness or lightheadedness
Headache
Nausea
Burning sensation
Anxiety.

Uncommon (affect less than 1 in 100 patients)

Sensation of pressure in the head
Blurred vision
Palpitations, sinus tachycardia
Metallic taste in the mouth
Breathing more frequently and deeply than usual (hyperventilation)
Sensation of heaviness in the arms
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 (slowed heart rate)
Life-threatening irregular heartbeat (torsade de pointes – a type of ventricular arrhythmia)
Ventricular fibrillation, atrial fibrillation.

Frequency not known (cannot be estimated from the available data)

Loss of consciousness
Fainting
Seizures, particularly in patients with a predisposition to seizures
Hypotension
Absence of ventricular contractions
Cardiac arrest (asystole), sometimes with fatal outcome, particularly in patients with concomitant ischemic heart disease or other heart conditions
Myocardial infarction
Coronary artery spasm, potentially leading to myocardial infarction
Stroke or transient ischemic attack
Vomiting
Respiratory failure
Apnea and/or respiratory arrest
Anaphylactic reaction (angioedema manifested by swelling of the lips, face, tongue, or throat, and difficulties in breathing and swallowing; urticaria; rash).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 this medicine.

5. How to store Adenosinum Inpharm

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 for single use only and should be used immediately after opening.
Any unused portion of the solution remaining after opening must be discarded.
If the doctor or nurse observes any particles in the solution or discoloration prior to injection, Adenosinum Inpharm 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 required. Such measures help protect the environment.

6. Contents of the package and other information

What Adenosinum Inpharm 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 in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
VIANEX A.E.
8 Varibobi str.
14671 N. Erythrea, Kifisia
Greece
Manufacturer:
VIANEX A.E. – Plant A', 12th km Athens-Lamia National Road, 14451 Metamorfosis, Attica, Greece
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, the country of export: 131653/05-11-2019
Parallel Import Licence Number: 315/25