Atepodin 100 mg polvo y disolvente para solucion inyectable

Patient Information Leaflet

ATEPODIN 100 mg powder and solvent for solution for injection

Adenosine triphosphate (sodium salt)

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medication is for diagnostic use and therapeutic use.

Atepodín contains the active ingredient 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 tachycardia. It is also used as a coronary vasodilator, as it increases blood flow to the heart muscle, for heart imaging tests with radioactive tracers that visualize this flow, only in adults who cannot exercise sufficiently for this test.

No use Atepodín in case of:

• Being allergic to adenosine triphosphate (sodium salt) or any of the other components of this medication (listed in section 6).
• Suffering from any heart rhythm disorder, such as second- or third-degree atrioventricular (AV) block, or sinoatrial dysfunction, unless wearing a functioning artificial pacemaker.
• Unstable angina that has not been stabilized with medical treatment.
• Severe low blood pressure (hypotension).
• Decompensated heart failure.
• Asthma or other severe respiratory problems that cause bronchospasm or bronchoconstriction.
• Preterm or newborn babies.

Warnings and precautions

Atepodín administration must be performed exclusively in a hospital setting with cardiac monitoring and cardio-respiratory resuscitation equipment.

Be especially careful with Atepodín:

Before administering Atepodín, your doctor needs to know if:

• You have a heart rhythm disorder called long QT syndrome.
• You suffer from a type of heart rhythm disorder called supraventricular tachycardia associated with the so-called Wolff-Parkinson-White syndrome.
• You have low blood volume (hypovolemia), or if you have problems with a part of your nervous system called the autonomic nervous system, or a narrowing (stenosis) of the left main coronary artery, or valvular heart disease due to narrowing of the same, or inflammation of the membrane surrounding the heart (pericarditis), or an accumulation of fluid around it (pericardial effusion), or also a narrowing of the main neck artery (carotid) with cerebrovascular insufficiency.
• You have initially elevated intracranial pressure.
• You have liver or kidney diseases, as large amounts of benzyl alcohol (present in the suitable solvent ampoule) may accumulate in the body and cause adverse effects (metabolic acidosis).

Before administering Atepodín, you must:

• Ensure metabolic balance
• Continuously monitor your heart and pulse
• Avoid taking dipiridamol for at least two days before administering Atepodín.

Children and adolescents

The safety and efficacy of Atepodín have not been established in children and adolescents, and no dosage recommendation can be made.

Atepodín contains benzyl alcohol (present in the suitable solvent ampoule), which has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

Atepodín should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist advises it.

Use of Atepodín with other medications

Inform 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 before administering Atepodín.
• Dipiridamol: Avoid taking dipiridamol for at least two days before administering Atepodín, when possible.
• Other cardioactive medications: carbamazepine, verapamil, quinidine, and diazepam.

Use of Atepodín with food and beverages

In patients undergoing pharmacological stress tests, administering Atepodín with food or beverages may change its effects. Therefore, do not take tea, cola, coffee, or chocolate, or eat chocolate for at least 24 hours before administering the medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. This is because large amounts of benzyl alcohol (present in the suitable solvent ampoule) may accumulate in your body and cause adverse effects (metabolic acidosis).

Pregnancy

There are no data, or these are limited, regarding the use of adenosine triphosphate (sodium salt) in pregnant women. Animal studies are insufficient in terms of reproductive toxicity. Adenosine triphosphate (sodium salt) is not recommended during pregnancy unless your doctor considers that the benefit outweighs the risk for the mother and the fetus.

Lactation

The metabolites of adenosine are unknown to be excreted in breast milk.

Atepodín should not be used during lactation.

Fertility

No fertility studies have been conducted with Atepodín

Driving and operating machinery

No studies have been conducted on the effects of Atepodín on the ability to drive and operate machinery. Atepodín administration may cause adverse reactions such as dizziness, headache, and shortness of breath shortly after administration. However, most adverse reactions are mild and transient. Therefore, it can be expected that the influence of Atepodín on the ability to drive or operate machinery will be negligible once the treatment has ended and these reactions have resolved.

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

Atepodíncontains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially "sodium-free".

ATEPODIN 100 mg IS EXCLUSIVELY FOR HOSPITAL USE AS IT MUST BE MADE AVAILABLE WITH ELECTROPHYSIOLOGICAL MONITORING AND CARDIOPULMONARY RESUSCITATION.

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

It must be administered intravenously via rapid injection or continuous infusion according to the indicated dosage below in accordance with the mode of use:

• For diagnostic and therapeutic use in supraventricular tachycardias

Adults:

• Therapeutic dose: a rapid intravenous bolus of 10 mg (<2>
• Diagnostic dose:the indicated dosage may be administered until sufficient diagnostic information is obtained.

• For diagnostic use as a pharmacological stress agent:

Adults:

It is recommended to administer Atepodín diluted in the form of a continuous peripheral intravenous infusion at a rate of 160 μg/kg/min for five minutes.

Older patients, with hepatic or renal insufficiency:

In any of the modes of use mentioned, no dose adjustment is necessary.

Repeated use:

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

If you have received more Atepodín than you should have:

Overdose would cause severe blood pressure drop, slowing of heart rate, or cardiac arrest, which would be resolved very quickly by stopping the infusion. Administration of aminophylline or theophylline via endovenous route may be necessary.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Adverse reactions are presented grouped by their frequency:

• Very frequent (affects more than 1 user in 10).

Hot flashes, facial flushing, shortness of breath (dyspnea), headache, chest pain, or discomfort, and abdominal discomfort.

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

Dizziness, vertigo; numbness, tingling, or pins and needles (paresthesias), hypotension, a heart problem called atrioventricular block (AV), tachycardia, dry mouth, and discomfort in the throat, neck, or jaw.

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

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

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

Difficulty breathing (bronchospasm), nasal congestion, cough, drowsiness, blurred vision, ringing or buzzing in the ear (tinnitus), sensation of urinary urgency, breast tenderness, and tremors.

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

Respiratory insufficiency and reactions at the injection site.

• Unknown frequency (cannot be estimated from available data).

Severe heart problem that may lead to cardiac arrest (asystole), arrhythmia, 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 may cause a heart attack.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging.

Use immediately after reconstitution. Do not use the remaining contents of a vial that has already been reconstituted.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of Atepodín

• The active principle is adenosine triphosphate (sodium salt). Each vial contains 100 mg of adenosine triphosphate (sodium salt)
• The other components are gelatin, benzyl alcohol (0.015 mg/ml reconstituted) and water for injection preparations.

Atepodín contains benzyl alcohol (present in the suitable solvent vial) (see section 2).

Appearance of the product and contents of the packaging

Box with a single-use vial, with a white lyophilized powder and a transparent and colorless solvent vial with water for injection preparations.

Marketing Authorization Holder

Medix Laboratories, S.A.

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

19200- Azuqueca de Henares (Guadalajara)

Manufacturer

Reig Jofré Laboratory, S.A.

C/ Gran Capitán, 10, Sant Joan Despí

08970 Barcelona

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Last review date of this leaflet: August 2023

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.es/

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This information is intended solely for doctors or healthcare professionals:

The complete technical file of Atepodín 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 medication.

Please consult the technical file.