ATEPODIN 100 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

ATEPODIN 100 mg powder and solvent for solution for injection

Adenosine triphosphate (disodium salt)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Atepodin and what is it used for
2. What you need to know before you use Atepodin
3. How to use Atepodin
4. Possible side effects
5. Storage of Atepodin
6. Contents of the pack and other information

1. What is Atepodin and what is it used for

This medicinal product is for diagnostic and therapeutic use.

Atepodin contains the active substance adenosine triphosphate (disodium salt). It is used as an antiarrhythmic for the treatment and aid in the diagnosis of a type of heart rhythm disorder called paroxysmal supraventricular tachycardia. It is also used as a coronary vasodilator, as it increases blood flow to the heart muscle, for cardiac imaging tests with radiopharmaceuticals where this flow is visualized, only in adults who cannot exercise sufficiently for this test.

2. What you need to know before you use Atepodin

Do not use Atepodin if:

• You are allergic to adenosine triphosphate (disodium salt) or any of the other ingredients of this medicinal product (listed in section 6).
• You have any 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 other severe respiratory problems that cause bronchospasm or bronchoconstriction.
• You are a premature or newborn infant.

Warnings and precautions

Atepodin should only be administered in a hospital setting with cardiac monitoring and cardiorespiratory resuscitation equipment.

Be careful with Atepodin:

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 the autonomic nervous system, or narrowing (stenosis) of the left main coronary artery, or valvular heart disease due to narrowing of the valves, or inflammation of the membrane surrounding the heart (pericarditis), or fluid accumulation around it (pericardial effusion), or narrowing of the main neck artery (carotid) with cerebrovascular insufficiency.
• You have initially elevated intracranial pressure.
• If you have liver or kidney disease, as large amounts of benzyl alcohol (present in the solvent ampoule) may accumulate in your body and cause side effects (metabolic acidosis).

Before administering Atepodin:

• ensure metabolic balance
• continuously monitor your heart and pulse
• avoid taking dipyridamole for at least 2 days prior to Atepodin administration.

Children and adolescents

The safety and efficacy of Atepodin in children and adolescents have not been established, and a dosage recommendation cannot be made.

Atepodin contains benzyl alcohol (present in the solvent ampoule) which has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children. Do not administer this medicinal product to your newborn (up to 4 weeks of age) unless it has been recommended by your doctor.

Atepodin should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Using Atepodin with other medicines

Tell your doctor or pharmacist if you are taking:

• Methylxanthines: you should avoid consuming any product containing methylxanthines (e.g. caffeine and theophylline) for at least 24 hours prior to Atepodin administration.
• Dipyridamole: you should avoid taking dipyridamole for at least 2 days prior to Atepodin administration, whenever 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 change its effects. Therefore, you should not consume tea, cola, coffee, or cocoa, or eat chocolate for at least 24 hours before Atepodin administration.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. This is because large amounts of benzyl alcohol (present in the solvent ampoule) may accumulate in your body and cause side effects (metabolic acidosis).

Pregnancy

There are limited data on the use of adenosine triphosphate (disodium salt) in pregnant women. Animal studies are insufficient with regard to reproductive toxicity. Adenosine triphosphate (disodium salt) should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks to the mother and fetus.

Breastfeeding

It is unknown whether adenosine metabolites are excreted in 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. The administration of Atepodin may cause adverse reactions such as dizziness, headache, and shortness of breath shortly after administration. However, most adverse reactions are mild and transient. Consequently, it is expected that the influence of Atepodin on the ability to drive or use machines will be negligible or insignificant once the treatment has been completed and these reactions have resolved.

Atepodincontains 0.15 ml of benzyl alcohol per solvent ampoule, which corresponds to 0.157 mg/ampoule of solvent, which may cause allergic reactions.

Atepodincontains less than 1 mmol of sodium (23 mg) per ampoule, i.e. it is essentially "sodium-free".

3. How to use Atepodin

ATEPODIN 100 mg IS EXCLUSIVELY FOR HOSPITAL USE AS IT REQUIRES ELECTROPHYSIOLOGICAL MONITORING AND CARDIORESPIRATORY RESUSCITATION.

Since Atepodin causes a rapid increase in heart rate, you should remain seated or lying down and be monitored at frequent intervals after injection until the electrocardiogram parameters, heart rate, and blood pressure have returned to pre-Atepodin administration levels.

It should be administered intravenously in rapid injection or continuous infusion according to the posology indicated below, depending on the mode of use:

• For diagnostic and therapeutic use in supraventricular tachycardias

Adults:

• therapeutic dose: a rapid intravenous bolus of 10 mg (<2 seconds) is recommended. if after 2 minutes there no reversion, a second bolus of 15 mg may be administered. 1 or the tachycardia has not reverted, third dose 20 administered.< li>
• diagnostic dose: the above-mentioned posology may be administered until sufficient diagnostic information is obtained.

• For diagnostic use as a pharmacological stress agent:

Adults:

Atepodin diluted in peripheral intravenous continuous infusion is recommended at a rate of 160 μg/kg/min for five minutes.

Elderly patients, with hepatic or renal insufficiency:

No dose adjustment is necessary in any of the above-mentioned modes of use.

Repeated use:

This product should only be administered once in a 24-hour period.

If you have received more Atepodin than you should:

Overdose would cause severe hypotension, bradycardia, or cardiac arrest, which would resolve rapidly upon discontinuation of the infusion. Administration of aminophylline or theophylline by intravenous route may be necessary.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects related to the known pharmacological characteristics of adenosine triphosphate (disodium salt) are frequent (30-80%), but generally self-limiting and highly transient. It may be necessary to interrupt the infusion if the effect is not well tolerated.

Adverse reactions are presented grouped by frequency:

• very common (affects more than 1 user in 10).

Flushing, facial redness, shortness of breath or urge to breathe deeply (dyspnea), headache, chest pain or tightness, and abdominal discomfort.

• common (affects less than 1 user in 10).

Dizziness, vertigo; numbness, tingling, or sensation of pins and needles (paresthesia), hypotension, a heart condition called atrioventricular (AV) block, increased heart rate, dry mouth, and discomfort in the throat, neck, or jaw.

• uncommon (affects less than 1 user in 100).

Metallic taste, sweating, discomfort in the legs, arms, or back, feeling of general malaise/weakness/pain, nervousness, slow heart rate (bradycardia).

• rare (affects less than 1 user in 1,000).

Breathing difficulties (bronchospasm), nasal congestion, cough, drowsiness, blurred vision, ringing or buzzing in the ears (tinnitus), urge to urinate, nipple discomfort, and tremors.

• very rare (affects less than 1 user in 10,000).

Respiratory failure and reactions at the injection site.

• frequency not known (cannot be estimated from the available data).

Severe heart condition that can lead to cardiac arrest (asystole), irregular heart rhythm (fibrillation), fainting or brief loss of consciousness (syncope), seizures, absence of spontaneous breathing (apnea), and respiratory arrest, nausea, and vomiting.

Spasm of the coronary artery that can cause a heart attack.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atepodin

Keep this medicine out of the sight and reach of children.

Store in the original package.

Use immediately after reconstitution. Do not use the remaining contents of a reconstituted vial.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. The disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Atepodin

• The active substance is adenosine triphosphate (disodium salt). Each vial contains 100 mg of adenosine triphosphate (disodium salt)
• The other ingredients are glycolic acid, benzyl alcohol (0.015 mg/ml reconstituted), and water for injections.

Atepodin contains benzyl alcohol (present in the solvent ampoule) (see section 2).

Appearance and pack contents

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

Marketing authorisation holder

Laboratorios Medix, S.A.

c/ Del Plástico 5, nave 9, Pol. Ind. Miralcampo

19200- Azuqueca de Henares (Guadalajara)

Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10, Sant Joan Despí

08970 Barcelona

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder.

Date of last revision of this leaflet: August 2023

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/

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This information is intended only for healthcare professionals:

The complete technical data sheet for Atepodin is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please consult the technical data sheet.