ADENOSINE HIKMA 6 mg/2ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Adenosine Hikma 6 mg/2 ml, Solution for Injection EFG

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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Adenosine Hikma and what is it used for
2. What you need to know before you are given Adenosine Hikma
3. How Adenosine Hikma is given
4. Possible side effects

5 Storage of Adenosine Hikma

1. Contents of the pack and other information

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

Adenosine Hikma contains adenosine. This belongs to a group of medicines called anti-arrhythmics.

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

Adenosine is used:

• During a test. It helps doctors find out what type of arrhythmia (irregular heartbeat) you have.
• To return your heartbeat to normal if you have a type of arrhythmia called supraventricular tachycardia (SVT) or 'Wolff-Parkinson-White Syndrome'.

Children:

In children, adenosine is used to return their heartbeat to normal if they have a type of heart rhythm problem called supraventricular tachycardia (SVT).

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

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

Do not use this medicine and tell your doctor if:

• You are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can be a rash, difficulty swallowing or breathing, or swelling of the lips, face, throat or tongue.
• You have asthma or other severe respiratory problems
• You have very low blood pressure (severe hypotension)
• You have a type of heart failure where the heart does not pump enough blood
• You have heart rhythm problems and do not have a pacemaker implanted (second or third degree atrioventricular block, sick sinus syndrome)
• You have been told you have 'long QT syndrome'. This is a rare heart problem that can lead to fast heartbeats and fainting.

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

Warnings and Precautions

Tell your doctor or nurse before you start using Adenosine Hikma if:

• You have a certain type of irregular heartbeat (atrial fibrillation or atrial flutter) and in particular if you have an 'accessory conduction pathway'.
• You have a heart problem where 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 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 the neck (carotid arteries). This means that not enough blood is getting to the brain (cerebrovascular insufficiency)
• You have had or currently have seizures
• 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 artery that supplies blood to the heart (left coronary artery stenosis)
• You have recently had a heart attack or severe heart failure, or have had a heart transplant in the last year
• You have any minor heart problems (first degree atrioventricular block or bundle branch block). These conditions may worsen temporarily when receiving adenosine
• Treatment with adenosine should be discontinued if you experience very slow heartbeats (severe bradycardia), respiratory failure, a life-threatening heart problem (asystole), severe chest pain (angina), or very low blood pressure (severe hypotension).
• You have unstable angina (chest pain due to altered circulation in the coronary arteries) that is not properly controlled with medical treatment.

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

Your doctor will stop treatment with adenosine if you experience any serious side effects.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given adenosine.

Children and Adolescents

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

If you are not sure if the above applies to your child, talk to your doctor or nurse before they are given adenosine.

Patients with Kidney or Liver Disease

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

Other Medicines and Adenosine Hikma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines.

This is because adenosine can affect how other medicines work.

Also, some medicines can affect how adenosine works.

In particular, tell 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 you are taking dipyridamole. Your doctor may decide that you should not receive adenosine or tell you to stop taking dipyridamole 24 hours before you are given adenosine, or a lower dose of adenosine may be necessary
• Your doctor may tell you to stop taking aminophylline or theophylline (medicines used to make breathing easier) 24 hours before you are given adenosine
• Caffeine (which is sometimes part of headache medicines)
• Adenosine may interact with other medicines that inhibit conduction (e.g. beta-adrenergic blockers, digitalis, or verapamil) or accelerate it (e.g. beta-sympathomimetics).

Adenosine Hikma with Food and Drink

You should avoid foods and drinks that contain caffeine, such as tea, coffee, chocolate, and cola, for at least 12 hours before you are given adenosine.

Pregnancy and Breastfeeding

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

Pregnancy

Adenosine should not be given to you if you are pregnant or think you may be pregnant, unless it is absolutely necessary

Breastfeeding

Adenosine should not be given to you if you are breastfeeding

C

Unknown.

Adenosine Hikma contains Sodium

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

3. How Adenosine Hikma is Given

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

If you are not sure why you are being given adenosine or have questions about the amount of adenosine you are receiving, ask your doctor or nurse.

The Recommended Dose is (Adults and Elderly Patients)

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

Diagnostic dose:

The above dose escalation scheme should be used until sufficient diagnostic information is obtained.

Use in Children and Adolescents

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

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

• Your child will be closely monitored, including recording their heart activity with an electrocardiogram (ECG)
• A doctor or nurse will give it as an injection into a vein in your child.

If you have been Given too Much Adenosine Hikma

Since this medicine is given by a doctor or nurse, it is unlikely that you will be given too much. Your doctor will carefully calculate how much adenosine you should be given.

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

• Very low blood pressure (severe hypotension).
• Slow heartbeat (bradycardia).
• Heartbeat stops (asystole, cardiac arrest).

Your doctor will continuously monitor your heart during the procedure.

Since the time adenosine stays in the blood is very short, any side effects due to an overdose of adenosine will stop quickly when the injection is stopped. Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 is finished, you should tell your doctor or nurse if they occur.

If any of the following side effects get worse, tell your doctor or nurse, as they may need to stop the injection:

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

• Redness of the skin with a feeling of heat (flushing)
• Slow heartbeats (bradycardia)
• Extra or skipped heartbeats
• A heart problem called atrioventricular block (AV block)
• Heart problems usually transient and self-limiting (asystole)
• Difficulty breathing or need to breathe deeply (dyspnea)
• Chest pain or feeling of pressure in the chest

Common (may affect up to 1 in 10 people)

• Feeling dizzy or lightheaded
• Nausea
• Headache
• Unusual sensations in the skin, such as burning
• Feeling nervous

Uncommon (may affect up to 1 in 100 people)

• Blurred vision
• Perception of heartbeats or feeling that the heart is 'racing'
• Metallic taste in the mouth
• Breathing more quickly or deeply than normal (hyperventilation)
• Feeling of pressure inside the skull
• Feeling of general discomfort, weakness, or pain
• Sweating

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

• Significant difficulty breathing or breathing problems
• Redness, pain, or swelling at the injection site
• Feeling of discomfort during the injection
• Worsening of high blood pressure in 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 can be life-threatening (asystole) or irregular heartbeats
• Fainting
• Seizures
• Vomiting
• Stopping breathing (respiratory arrest)
• Low blood pressure, sometimes severe
• Stroke or transient ischemic attack, secondary to the hemodynamic effects of adenosine including hypotension
• Allergic reactions including swelling of the face or throat, and skin reactions such as hives or rash
• Small heart attack (myocardial infarction/elevated ST segment) especially in patients with pre-existing coronary artery disease
• Spasm of the heart artery that can cause a heart attack.

If any of the above side effects get worse, tell your doctor or nurse, as they may need to stop the injection. Although side effects usually resolve within seconds or minutes after the injection is finished, you should tell your doctor or nurse if they occur.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, 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 which is stated on the carton and ampoule after EXP. The expiry date is the last day of the month stated.

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

The product is for single use and should be used immediately after opening. Any unused portion of the ampoule should be discarded.

This medicine should not be used if particles are visible in the solution or if the color has changed before administration.

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

6. Contents of the Pack and Other Information

Composition of Adenosine Hikma

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

Each 2 ml ampoule contains 6 mg of adenosine. Each milliliter of the solution for injection contains 3 mg of adenosine.

Appearance and Packaging

Adenosine Hikma is a clear, colorless, and particle-free solution.

Each pack contains 10 ampoules.

Marketing Authorization Holder and Manufacturer Marketing Authorization Holder:

Hikma Pharmaceuticals (Portugal), S.A.

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

2705-906 Terrugem SNT

Portugal

Manufacturer:Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italy

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Hikma Spain, S.L.U.

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

28108 - Alcobendas, Madrid

Spain

Date of last revision of this leaflet: July 2023

Detailed and updated 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/

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This information is intended only for healthcare professionals:

Posology and method of administration

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

Posology

Adults

Additional doses or higher doses are not recommended.

Pediatric population

During 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).

Elderly patients

See recommended posology in adults.

Method of administration

It should be administered by rapid intravenous injection (intravenous bolus), according to the above dose escalation table. To ensure that the solution reaches the systemic circulation, it should be administered directly into a vein or into an intravenous catheter. If administered through an intravenous catheter, the injection should be injected as proximally as possible, followed by rapid flushing with physiological serum. If administered through a peripheral vein, a large-caliber cannula should be used.

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

Diagnostic dose

The above dose escalation 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 others.

Special precautions for disposal and other handling

None special.

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.