Adenosine Hikma 6 mg/2 ml solution for injection EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Adenosine Hikma 6 mg/2 ml, injection solution EFG

Read the entire leaflet carefully before you start using 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, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents

1. What Adenosine Hikma is and what it is used for

2. What you need to know before you are given Adenosine Hikma

3. How Adenosine Hikma is administered

4. Possible side effects

5. Storage of Adenosine Hikma

6. Contents of the pack and other information

1. What Adenosine Hikma is and what it is used for

Adenosine Hikma contains adenosine. This belongs to a group of medicines 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 known as arrhythmias.

Adenosine is used:

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

Children:

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

Adenosine has been shown to be ineffective in patients with atrial or ventricular tachycardia, or with tachycardia attributable to atrial fibrillation or atrial flutter.

2. What you need to know before Adenosine Hikma is administered to you

Do not use this medicine and inform your doctor if:

• You are allergic to adenosine or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue.
• You have asthma or another serious breathing problem
• You have very low blood pressure (severe 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, sinus node dysfunction)
• You have been diagnosed with "long QT syndrome". This is a rare heart condition that may lead to rapid heartbeats and fainting.

Do not use this medicine if any of the above apply to you. If in doubt, consult your doctor or nurse before receiving adenosine.

Warnings and precautions

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

• You have a certain type of abnormal heart rhythm (atrial fibrillation or atrial flutter), particularly if you have an 'accessory conduction pathway'.
• You have a heart condition in which 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 called the 'autonomic nervous system'.
• You have narrowing of the main arteries in your neck (carotid arteries). This means that insufficient blood reaches the brain (cerebrovascular insufficiency).
• You have or have ever 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 fluid accumulation around the heart (pericardial effusion).
• You have a left-to-right shunt in the heart. This means that blood passes directly from the left side to the right side of the heart.
• You have narrowing of the main left artery supplying blood to the heart (left main coronary artery stenosis).
• You have recently had a heart attack or severe heart failure, or have undergone a heart transplant within the past year.
• You have any minor heart conduction problems (first-degree atrioventricular block or bundle branch block). These conditions may temporarily worsen when receiving adenosine.
• Treatment with adenosine must be discontinued if you experience very slow heartbeats (severe bradycardia), respiratory failure, a potentially fatal heart condition (asystole), severe chest pain (angina pectoris), or very low blood pressure (severe hypotension).
• You have unstable angina (chest pain due to impaired circulation in the coronary arteries) that has not been 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 adenosine treatment if you experience any serious adverse reaction.

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

Children and adolescents

In pediatric patients with a heart rhythm disorder called 'Wolff-Parkinson-White (WPW) syndrome', the adenosine bolus may cause serious 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), hepatic or renal insufficiency should not affect the efficacy and tolerability of adenosine.

Other medicines and Adenosine Hikma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal remedies.

This is because adenosine may affect how other medicines work.

In addition, some medicines may affect how adenosine works.

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

• Dipyridamole (a medicine used to reduce blood clotting). Make sure your doctor knows that you are taking dipyridamole. Your doctor may decide that you should not receive adenosine, or may instruct you to stop taking dipyridamole 24 hours before adenosine is administered, or a lower dose of adenosine may need to be given
• Your doctor may instruct you to stop taking aminophylline or theophylline (medicines used to help breathing) 24 hours before adenosine is administered
• Caffeine (which is sometimes included in headache medicines)
• Adenosine may interact with other medicines that either slow conduction (e.g. adrenergic beta-blockers, digitalis, or verapamil) or increase it (e.g. beta-sympathomimetics).

Adenosine Hikma with food and beverages

You should avoid foods and beverages containing caffeine, such as tea, coffee, chocolate, and cola drinks, for at least 12 hours before receiving adenosine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before you are given this medicine.

Pregnancy

Adenosine should not be administered to you if you are pregnant or think you might be, unless absolutely necessary.

Breastfeeding

Adenosine should not be administered to you if you are breastfeeding.

Driving and use of machines

Unknown.

Adenosine Hikma contains sodium

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

3. How Adenosina Hikma is administered

• Adenosina is a medicine for use in hospitals with resuscitation equipment available.
• It will be given to you by a doctor or nurse as an injection into a vein.
• Your heart and blood pressure will be closely monitored.

If you are unsure why you are being given adenosina or have questions about the amount of adenosina you are receiving, consult your doctor or nurse.

Recommended dose (adults and elderly patients)

• The first dose is 3 mg administered over 2 seconds. It is given as a rapid injection into a vein.
• If the first dose does not normalize the heart rhythm, a second dose will be administered. The second dose is 6 mg given as a rapid injection.
• If the second dose does not normalize the heart rhythm, a third dose will be administered: The third dose is 12 mg given as a rapid injection.
• No further doses should be administered after the 12 mg dose.

Diagnostic dose:

The above escalating dose regimen should be used until sufficient diagnostic information is obtained.

Use in children and adolescents

Adenosine is a hospital-use medicine that requires resuscitation equipment to be available.

Your doctor will decide whether it is necessary to use this medicine, the amount to be administered according to your child's weight, and whether repeated injections are needed.

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

If you have been given more Adenosine Hikma than you should have

As this medicine is administered by a doctor or nurse, it is unlikely that you will receive more than you should. Your doctor will carefully calculate the amount of adenosine to be given to you.

If you are given more medicine than you should have, the following effects may occur:

• Very low blood pressure (severe hypotension).
• Slow heart rate (bradycardia).
• Cessation of heartbeat (asystole, cardiac arrest).

Your doctor will continuously monitor your heart during the procedure.

Because adenosine remains in the blood for a very short time, any adverse effects due to an overdose of adenosine will rapidly cease once the injection is stopped. Occasionally, you may need an injection of a medicine called aminophylline or theophylline to help counteract a possible adverse effect.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

If any of the following adverse effects worsens, inform your doctor or nurse, as they might stop the injection:

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

• Skin redness with a sensation of warmth (flushing)
• Slow heartbeats (bradycardia)
• Extra or intermittent heartbeats
• Heart problem called atrioventricular (AV) block
• Heart problems usually transient and self-limiting (asystole)
• Difficulty breathing or need to take a deep breath (dyspnea)
• Pain or tightness in the chest

Frequent (may affect up to 1 in 10 people)

• Dizziness or lightheadedness
• Nausea
• Headache
• Unusual skin sensations, such as burning
• Feeling of nervousness

Uncommon (may affect up to 1 in 100 people)

• Blurred vision
• Awareness of heartbeat or sensation that the heart is 'racing'
• Metallic taste in the mouth
• Breathing faster or more deeply than normal (hyperventilation)
• Sensation of pressure inside the skull
• Feeling 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
• Feeling of discomfort during injection
• Worsening of arterial hypertension affecting the brain (intracranial hypertension)
• Very slow, fast, or irregular heartbeats
• Severe bradycardia (very slow heartbeats)

Not known (frequency cannot be estimated from the available data)

• Severe heart problems that may be fatal (asystole) or irregular heartbeats
• Fainting
• Seizures
• Vomiting
• Cessation of breathing (respiratory arrest)
• Hypotension, sometimes severe
• Stroke/transient ischemic attack, secondary to the hemodynamic effects of adenosine including hypotension
• Allergic reactions including facial or throat swelling, and skin reactions such as hives or rash
• Minor heart attack (myocardial infarction/ST-segment elevation), especially in patients with pre-existing coronary artery disease
• Spasm of the heart artery that may lead to a heart attack

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Adenosine Hikma

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

Do not use this medicine after the expiry date stated on the carton and on the ampoule, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Do not refrigerate.

This product is for single use only and should be used immediately after opening. Any unused portion remaining in the ampoule must be discarded.

This medicine should not be used if particles are observed in the solution or if there are any changes in colour before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Adenosina Hikma

• The active substance is adenosine.
• The other components are sodium chloride (see section 2) and water for injections.

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

Appearance of the product and contents of the container

Adenosine Hikma is a clear, colourless solution free from visible particles.

Each pack contains 10 ampoules.

Marketing Authorization Holder and Manufacturing Responsible Party Marketing Authorization Holder:

Hikma Farmacêutica (Portugal), S.A.

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

2705-906 Terrugem SNT

Portugal

Manufacturing Responsible Party: Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italy

For further information about this medicinal product, please contact 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 most recent review of this leaflet: July 2023

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.gob.es/

This information is intended for healthcare professionals only:

Posology and method of administration

Adenosine injectable solution is for hospital use only, with monitoring and cardiopulmonary resuscitation equipment immediately available if needed.

Posology

Adults

Additional or higher doses are not recommended.

Paediatric population

During administration of adenosine, a cardiopulmonary resuscitation team and equipment must be immediately available in case they are needed.

Adenosine is intended to be used with continuous ECG monitoring and recording during administration.

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

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

Elderly patients

See recommended dosage for adults.

Method of administration

It must be administered as a rapid intravenous injection (intravenous bolus), according to the above-mentioned dose escalation table. To ensure that the solution reaches the systemic circulation, it should be administered directly into a vein or intravenous catheter. If administered through an intravenous catheter, the injection should be given as proximally as possible, followed immediately by a rapid saline flush. If administered via a peripheral vein, a large-bore cannula should be used.

Adenosine should only be used when facilities for cardiac monitoring are available. Patients who develop high-grade AV block at any given dose should not receive further dose increments.

Diagnostic dose

The dose escalation regimen described above may be administered until sufficient diagnostic information has been obtained.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special precautions for disposal and other handling

None.

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