Leaflet: information for the user

Adenosina Hikma 6 mg/2 ml, injectable solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Content of the leaflet

1. What Adenosina Hikma is and for what it is used
2. What you need to know before Adenosina Hikma is administered to you
3. How to administer Adenosina Hikma
4. Possible side effects

5 Conservation of Adenosina Hikma

6. Contents of the package and additional information

Adenosina Hikma contains adenosine. This belongs to a group of medications called antiarrhythmics.

Adenosine works by slowing down the electrical impulses between the upper and lower chambers of the heart. This slows down rapid or irregular heartbeats called arrhythmias.

Adenosine is used:

• During a test. It helps doctors determine the type of arrhythmia (irregular heartbeat) you have.
• To restore a normal heartbeat if you have a type of arrhythmia called paroxysmal supraventricular tachycardia (SVT) or Wolff-Parkinson-White Syndrome.

Children:

In children, adenosine is used to restore a normal heartbeat if your child has a type of heart rhythm problem called paroxysmal supraventricular tachycardia (PSVT).

It has been shown that adenosine is ineffective in patients with atrial tachycardia or ventricular tachycardia, or with tachycardia attributable to atrial fibrillation or atrial flutter.

Do not use this medication and inform your doctor if:

• You are allergic to adenosine or any of the other components of this medication (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue.
• You have asthma or another serious respiratory problem
• You have severe low blood pressure (hypotension)
• You have a type of heart failure in which the heart does not pump enough blood
• You have problems with your heart rhythm and do not have a pacemaker implanted (second- or third-degree atrioventricular block, intrinsic dysfunction of the sinoatrial node)
• You have been told that you have "long QT syndrome". This is a rare heart problem that can cause rapid heartbeats and fainting.

Do not use this medication if any of the above applies to you. If in doubt, consult your doctor or nurse before adenosine is administered.

Warnings and precautions

Consult your doctor or nurse before starting to use Adenosina Hikma if:

• You have a certain type of irregular heart rhythm (atrial fibrillation or atrial flutter) and, in particular, if you have an 'accessory conduction pathway'
• You have a heart problem in which the electrical impulses in some parts of your heart take longer than normal to discharge and recharge (long QT interval)
• You have low blood volume (hypovolemia) that is not adequately corrected with medication
• You have problems with a part of your nervous system, known as the 'autonomic nervous system'
• You have narrowing of the main arteries in the neck (carotid arteries). This means that not enough blood is reaching the brain (cerebrovascular insufficiency)
• You have or have had seizures or convulsions
• You have difficulty breathing (bronchospasm)
• You have heart disease due to narrowing of the heart valves (valvular stenosis)
• You have inflammation of the membrane surrounding the heart (pericarditis) or accumulation of fluid around the heart (pericardial effusion)
• You have a left-to-right shunt in the heart. This means that blood passes directly from the left to the right side of the heart
• You have narrowing of the main left artery that distributes blood to the heart (left coronary artery stenosis)
• You have recently had a heart attack or severe heart failure, or have undergone a heart transplant in the past year
• You have any minor heart problem (first-degree atrioventricular block or branch block). These conditions may temporarily worsen when adenosine is administered
• Treatment with adenosine should be discontinued if you experience very slow heartbeats (severe bradycardia), respiratory failure, a potentially fatal heart problem (asystole), intense chest pain (angina pectoris), or very low blood pressure (severe hypotension).
• You have unstable angina (chest pain due to altered circulation in the coronary arteries) that is not adequately stabilized with medical treatment.

In patients who develop severe AV block at a particular dose, the dose should not be increased.

Your doctor will discontinue treatment with adenosine if you experience any severe side effects.

If you are unsure whether any of the above applies to you, speak with your doctor or nurse before receiving adenosine.

Children and adolescents

In pediatric patients with a heart rhythm problem called 'Wolff-Parkinson-White (WPW) syndrome', the adenosine bolus may cause severe and unexpected heart rhythm abnormalities.

If you are unsure whether the above applies to your child, speak with your doctor or nurse before receiving adenosine.

Patients with renal or hepatic disease

Since neither the kidneys nor the liver metabolize exogenous adenosine (administered), liver or kidney insufficiency should not affect the efficacy and tolerability of adenosine.

Other medications and Adenosina Hikma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription and herbal remedies.

This is because adenosine may affect how other medications work.

Additionally, some medications may affect how adenosine works.

In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• Dipyridamole (a medication used to reduce blood clotting). Ensure that your doctor knows that you are taking dipyridamole. Your doctor may decide that you should not receive adenosine or tell you to stop taking dipyridamole 24 hours before adenosine is administered, or it may be necessary to administer a lower dose of adenosine
• Your doctor may tell you to stop taking aminophylline or theophylline (medications used to facilitate breathing) 24 hours before adenosine is administered
• Caffeine (which is sometimes part of headache medications)
• Adenosine may interact with other medications that inhibit conduction (e.g., beta-adrenergic blockers, digitalis, or verapamil) or accelerate it (e.g., beta-adrenergic agonists)

Adenosina Hikma with food and drinks

Avoid foods and drinks that contain caffeine, such as tea, coffee, chocolate, and cola beverages, for at least 12 hours before adenosine is administered.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or nurse before this medication is administered.

Pregnancy

Adenosina should not be administered if you are pregnant or think you may be pregnant, unless it is absolutely necessary

Lactation

Adenosina should not be administered if you are breastfeeding

Conduction and use of machines

Unknown.

Adenosina Hikma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially "sodium-free".

• Adenosine is a medication for use in hospitals with available resuscitation equipment.
• It will be administered by a doctor or nurse through an injection into a vein.
• Your heart and blood pressure will be closely monitored.

If you are unsure of the reason you are receiving adenosine or have questions about the amount of adenosine you are receiving, consult with your doctor or nurse.

The recommended dose is (adults and elderly patients)

• The first dose is 3 mg administered in 2 seconds. It is administered through a rapid injection into a vein.
• If the first dose does not normalize the heartbeat, a second dose will be administered. The second dose is 6 mg administered as a rapid injection.
• If the second dose does not normalize the heartbeat, a third dose will be administered: The third dose is 12 mg administered as a rapid injection.
• You should not receive more doses after the 12 mg dose.

Diagnostic dose:

The previous escalating dose scale should be used until sufficient diagnostic information is obtained.

Use in children and adolescents

Adenosine is a hospital medication that requires available resuscitation equipment.

Your doctor will decide if this medication is necessary, the amount to be administered based on your child's weight, and if multiple injections are needed.

• Your child will be closely monitored, including the recording of the electrical activity of their heart through an electrocardiogram (ECG)
• A doctor or nurse will administer it as an injection into a vein of your child.

If you have received more Adenosine Hikma than you should

Since this medication is administered by a doctor or nurse, it is unlikely that you will receive more than you should. Your doctor will carefully calculate how much adenosine you should receive.

If you receive more medication than you should, the following effects may occur:

• Severe low blood pressure (hypotension).
• Slow heart rate (bradycardia).
• Cardiac arrest (asystole, cardiac arrest).

Your doctor will continuously monitor your heart during the process.

Since the time adenosine stays in the blood is very short, any adverse effect due to an overdose of adenosine will cease rapidly when the injection is stopped. Sometimes you may need an injection of a medication called aminophylline or theophylline to help with a possible adverse effect.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You may experience some of the following side effects during treatment with adenosine. Although side effects usually resolve within seconds or minutes after the injection ends, inform your doctor or nurse if they occur.

If any of the following side effects worsen, inform your doctor or nurse, as they may stop the injection:

Very common (may affect more than 1 in 10 people)

• Redness of the skin with a sensation of heat (rubefaction)
• Slow heartbeats (bradycardia)
• Extra or intermittent heartbeats
• A heart problem called atrioventricular (AV) block
• Usually transient and self-limiting heart problems (asystole)
• Difficulty breathing or need to breathe deeply (dyspnea)
• Chest pain or sensation of oppression

Common (may affect up to 1 in 10 people)

• Sensation of dizziness or lightheadedness
• Nausea
• Headache
• Unusual sensations in the skin, such as burning
• Sensation of nervousness

Rare (may affect up to 1 in 100 people)

• Blurred vision
• Perception of heartbeats or sensation of a 'racing' heart
• Metalllic taste in the mouth
• Respiring more quickly or more deeply than normal (hyperventilation)
• Sensation of pressure within the skull
• Sensation of general discomfort, weakness, or pain
• Sweating

Very rare (may affect up to 1 in 10,000 people)

• Significant dyspnea or breathing problems
• Redness, pain, or swelling at the injection site
• Sensation of discomfort during the injection
• Worsening of high blood pressure affecting the brain (intracranial hypertension)
• Very slow, rapid, or irregular heartbeats
• Severe bradycardia (very slow heartbeats)

Unknown (frequency cannot be estimated with available data)

• Severe heart problems that can be fatal (asystole) or irregular heartbeats
• Loss of consciousness
• Seizures
• Vomiting
• Stop breathing (respiratory arrest)
• Hypotension, sometimes severe
• Transient ischemic attack, secondary to the hemodynamic effects of adenosine, including hypotension
• Allergic reactions, including facial or throat swelling, and skin reactions such as urticaria or skin rash
• Small heart attack (myocardial infarction/elevation of the ST segment) especially in patients with pre-existing coronary artery disease
• Coronary artery spasm that can cause a heart attack.

If any of the following side effects worsen, inform your doctor or nurse, as they may stop the injection. Although side effects usually resolve within seconds or minutes after the injection ends, inform your doctor or nurse if they occur.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the box and on the ampule, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Do not refrigerate.

The product is for single use and should be used immediately after opening. Any remaining ampule not used should be discarded.

Do not use this medication if particles are observed in the solution or color changes before administering the medication.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Adenosina Hikma

Each ampoule of 2 ml contains 6 mg of adenosine. Each ml of injectable solution contains 3 mg of adenosine.

Appearance of the product and contents of the container

Adenosina Hikma is a transparent, colorless, and particle-free solution.

Each container contains 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization:

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 A-B – Fervença

2705-906 Terrugem SNT

Portugal

Responsible for manufacturing:Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italy

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Date of the last review of this leaflet: July 2023

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

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This information is intended solely for healthcare professionals:

Dosage and administration

Adenosina injectable solution is only for hospital use, with cardiopulmonary resuscitation equipment available for immediate use if necessary.

Dosage

Adults

No additional or higher doses are recommended.

Pediatric population

During the administration of adenosine, a cardiopulmonary resuscitation team should be available for immediate use if necessary.

Adenosine is designed for use with continuous monitoring and ECG recording during administration.

The recommended dose for the treatment of paroxysmal supraventricular tachycardia in the pediatric population is:

• first bolus of 0.1 mg/kg body weight (maximum dose of 6 mg)
• increases of 0.1 mg/kg body weight, as needed, until the supraventricular tachycardia is terminated (maximum dose of 12 mg).

Geriatric patients

See recommended dosage in adults.

Administration

It should be administered by rapid intravenous injection (bolus intravenous), in accordance with the ascending dose table above. To ensure that the solution reaches the systemic circulation, it should be administered directly into a vein or through an intravenous catheter. If administered through an intravenous catheter, the injection should be injected as close to the proximal end as possible, followed by rapid irrigation with physiological saline. If administered through a peripheral vein, a large-caliber cannula should be used.

Adenosine should only be used when cardiopulmonary monitoring facilities are available. Patients with high-grade AV block at a particular dose should not receive additional dose increments.

Diagnostic dose

The ascending dose regimen indicated above may be administered until sufficient diagnostic information is obtained.

Incompatibilities

In the absence of compatibility studies, this medication should not be mixed with others.

Special precautions for disposal and other manipulations

None.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.