Contents of the leaflet:

1.What Atepodin is and what it is used for
2.What you need to know before you start using Atepodin 100 mg
3.How to use Atepodin
4.Possible side effects
5.How to store Atepodin
6.Contents of the package and additional information

1. What Atepodin is and what it is used for

This medicine is for diagnostic and therapeutic use.
Atepodin contains the active ingredient adenosine triphosphate (disodium salt). It is used as an antiarrhythmic for the treatment and assistance in the diagnosis of a type of heart rhythm disorder called paroxysmal tachycardia.
It is also used as a coronary vasodilator, as it increases blood flow in the heart muscle, for imaging tests of the heart using radiopharmaceuticals that visualize this blood flow, only in adults who cannot perform sufficient exercise for such a test.

2. What you need to know before you start using Atepodin

Do not use Atepodin if:
•You are allergic to adenosine triphosphate (disodium salt) or any of the other ingredients of this medicine (listed in section 6).
•You have a heart rhythm disorder such as second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless you have a functioning artificial pacemaker.
•You have unstable angina that has not been stabilized with medical treatment.
•You have very low blood pressure (severe hypotension).
•You have decompensated heart failure.
•You have asthma or another severe respiratory problem that causes bronchospasm or bronchoconstriction.
•You are a premature baby or a newborn.

Warnings and precautions
The administration of Atepodin must be performed exclusively in a hospital setting with cardiac monitoring equipment and cardiopulmonary resuscitation capabilities.

Take special care with Atepodin if:
Before administering Atepodin, your doctor needs to know if:
•You have a heart rhythm disorder called long QT syndrome.
•You have a type of heart rhythm disorder called supraventricular tachycardia associated with Wolff-Parkinson-White syndrome.
•You have low blood volume (hypovolemia), or problems with part of your nervous system called the “autonomic nervous system,” or narrowing (stenosis) of the left main coronary artery, valvular heart disease due to narrowing, inflammation of the membrane surrounding the heart (pericarditis), or fluid accumulation around it (pericardial effusion), or narrowing of the main artery of the neck (carotid artery) with cerebrovascular insufficiency.
•You have initially elevated intracranial pressure.

Before the administration of Atepodin, you must:
•Ensure metabolic balance.
•Monitor your heart and pulse continuously.
•Avoid taking dipyridamole for at least two days prior to the administration of Atepodin.

Children and adolescents
Atepodin should not be administered to premature babies or newborns as it contains up to 0.15 mg of benzyl alcohol. It may cause toxic reactions and allergic reactions in children under 3 years of age. The safety and efficacy of Atepodin in children and adolescents have not been established, and a dosage recommendation cannot be made.

Using Atepodin with other medicines
Tell your doctor or pharmacist if you are taking:
•Methylxanthines: Avoid consuming any product containing methylxanthines (e.g., caffeine and theophylline) for at least 24 hours prior to the administration of Atepodin.
•Dipyridamole: Avoid taking dipyridamole for at least two days prior to the administration of Atepodin, when possible.
•Other cardioactive medicines: Carbamazepine, verapamil, quinidine, and diazepam.

Using Atepodin with food and drinks
In patients undergoing pharmacological stress tests, the administration of Atepodin with food or drinks may alter its effects. Therefore, you should not consume tea, cola, coffee, cocoa, or chocolate for at least 24 hours before taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to have a baby, ask your doctor before using this medicine.

Pregnancy
There are no or limited data on the use of adenosine triphosphate (disodium salt) in pregnant women. Studies in animals are insufficient regarding reproductive toxicity. The use of adenosine triphosphate (disodium salt) during pregnancy is not recommended unless the doctor considers the benefit outweighs the risk to the mother and the fetus.

Breastfeeding
It is unknown whether the metabolites of adenosine are excreted in human breast milk. Atepodin should not be used during breastfeeding.

Fertility
No fertility studies have been conducted with Atepodin.

Driving and using machines
No studies have been conducted on the effects of Atepodin on the ability to drive and use machines. Atepodin administration may cause adverse reactions such as dizziness, headache, and gasping shortly after administration. However, most adverse reactions are mild and temporary. Therefore, Atepodin is expected to have no or negligible influence on the ability to drive or use machines once treatment is completed and these reactions have resolved.

3. How to use Atepodin

ATEPODIN 100 mg IS FOR HOSPITAL USE ONLY, AS ELECTROPHYSIOLOGICAL MONITORING AND CARDIOPULMONARY RESUSCITATION MUST BE AVAILABLE.
Since Atepodin causes a rapid increase in heart rate, you must remain seated or lying down and be frequently monitored after the injection until heart rate and blood pressure parameters return to baseline levels. It must be administered intravenously as a rapid injection or continuous infusion, according to the dosage indicated below based on its use:
•For diagnostic and therapeutic use in supraventricular tachycardias.
Adults:
•Therapeutic dose: A rapid intravenous bolus of 10 mg (<2 seconds) is recommended. If no reversion occurs after 2 minutes, a second bolus of 15 mg may be administered. If after 1 or 2 minutes the tachycardia still does not revert, a third dose of 20 mg may be administered.
•Diagnostic dose: The above dosage may be used until sufficient diagnostic information is obtained.
•For diagnostic use as a pharmacological stress agent.
Adults:
•It is recommended to administer diluted Atepodin as a continuous peripheral intravenous infusion at a rate of 160 µg/kg/min for five minutes.
•Elderly patients, or those with hepatic or renal insufficiency:
No dose adjustment is necessary for any of the aforementioned uses.

Repeated use:
This product should only be administered once within a 24-hour period.

If you have received more Atepodin than you should have:
An overdose could cause a severe drop in blood pressure, a slowing of the heart rate, or cardiac arrest, which would resolve very quickly upon stopping the infusion. Intravenous administration of aminophylline or theophylline may be necessary.

4. Possible Side Effects

As with all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects related to the known pharmacological characteristics of adenosine triphosphate (disodium salt) are common (30-80%) but are generally self-limited and extremely short-lived. It may be necessary to stop the infusion if the effect is not well tolerated. Adverse reactions are grouped by frequency:
•Very common (affecting more than 1 in 10 users):
Flushing, facial redness, gasping or the urge to breathe deeply (dyspnea), headache, chest pain or tightness, and abdominal discomfort.
•Common (affecting fewer than 1 in 10 users):
Dizziness, vertigo; numbness, tingling, or pricking sensation (paresthesia), low blood pressure, a heart problem called atrioventricular (AV) block, rapid heart rate, dry mouth, and discomfort in the throat, neck, or jaw.
•Uncommon (affecting fewer than 1 in 100 users):
Metallic taste, sweating, discomfort in the legs, arms, or back, feelings of general discomfort/weakness/pain, nervousness, and slow heart rate (bradycardia).
•Rare (affecting fewer than 1 in 1,000 users):
Difficulty breathing (bronchospasm), nasal congestion, cough, drowsiness, blurred vision, ringing or buzzing in the ears (tinnitus), a feeling of urinary urgency, nipple discomfort, and tremors.
•Very rare (affecting fewer than 1 in 10,000 users):
Respiratory failure and reactions at the injection site.
•Frequency not known (cannot be estimated from the available data):
Severe heart problems that may lead to cardiac arrest (asystole), irregular heart rhythm (fibrillation), fainting or brief loss of consciousness (syncope), seizures, absence of spontaneous breathing (apnea), respiratory arrest, nausea, and vomiting.

Reporting of side effects
If you experience any side effects, talk to your doctor, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines at: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atepodin

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Use immediately after reconstitution. Do not use the remaining content of a vial once reconstituted.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.” The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.

6. Contents of the package and additional information

Composition of Atepodin
•The active ingredient is adenosine triphosphate (disodium salt). Each vial contains 100 mg of adenosine triphosphate (disodium salt).
•The other ingredients are glycine, benzyl alcohol (0.015 mg/ml when reconstituted), and water for injections.

Product appearance and package contents
Box with a single-use vial containing a white lyophilized powder and a clear, colorless solvent ampoule with water for injections.

Marketing authorization holder and manufacturer
LABORATORIOS MEDIX, S.A
Calle del Plástico, no 5 nave 9
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain.
For further information about this medicine, please contact the local representative of the marketing authorization holder.

Date of the last revision of this leaflet: February 2015

Other sources of information
Detailed and updated information about this medicine is available on the Spanish Agency of Medicines and Health Products (AEMPS) website: http://www.aemps.es/

This information is intended exclusively for doctors or healthcare professionals:
The complete technical data sheet for Atepodin is included as a separate document in the product package to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this medicine.

Please refer to the technical data sheet.