Adenosine Hikma

Package Leaflet: Information for the User

Adenosina Hikma, 6 mg/2 ml, injectable solution

Adenosine
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

What this leaflet contains:

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

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

Adenosina Hikma contains a medicine called adenosine. This belongs to a group of medicines called "antiarrhythmics".
Adenosina Hikma works by slowing down the electrical impulses between the upper and lower chambers of the heart. This slows down rapid and irregular heartbeats known as "arrhythmias".
Adenosina Hikma is used:

• During a diagnostic test. This helps doctors identify the type of arrhythmia (irregular heartbeat) you have.
• To restore normal heart rhythm if you have a type of arrhythmia called "paroxysmal supraventricular tachycardia (SVT)" or "Wolff-Parkinson-White syndrome".

Children
In children, Adenosina Hikma is used to restore normal heart rhythm if the child has a type of arrhythmia called "paroxysmal supraventricular tachycardia (PSVT)".
Adenosina Hikma has been shown to be ineffective in patients with atrial or ventricular tachycardia or tachycardias due to atrial fibrillation or atrial flutter.

2. What you need to know before using Adenosina Hikma

Do not take Adenosina Hikma if:

• you are allergic to adenosine or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• you have asthma or any other serious breathing problems.
• you have very low blood pressure (severe hypotension).
• you have a type of heart failure in which the heart is not pumping enough blood.
• you have heart rhythm problems and do not have a pacemaker (second- or third-degree atrioventricular block, sick sinus syndrome).
• you have been diagnosed with "long QT syndrome". This is a rare heart condition that may cause a fast heartbeat and fainting.

Do not take this medicine if any of the above conditions apply to you. If you are
not sure, consult your doctor or nurse before being given
Adenosina Hikma.
Warnings and precautions
Talk to your doctor or nurse before using Adenosina Hikma if:

• you have a certain type of abnormal heart rhythm (atrial fibrillation or atrial flutter), especially if you have an "accessory conduction pathway".

• you have a condition called long QT syndrome (prolonged QT interval).

• you have low blood volume (hypovolemia) that has not been adequately stabilized by medical therapy.

• you have disorders affecting a part of the nervous system called the "autonomic nervous system".

• you have narrowing of the main arteries in the neck (carotid artery stenosis). This means that blood supply to the brain is insufficient (cerebrovascular insufficiency).

• you have had or currently have seizures or convulsions.

• you have breathing difficulties (bronchospasm).

• you have narrowing of 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 flows directly from the left side of the heart to the right side.

• you have narrowing of the main left artery supplying blood to the heart (main left coronary artery stenosis).

• you have recently had a heart attack, severe heart failure, or a heart transplant within the past year.

• you have minor heart conduction problems (first-degree atrioventricular block or bundle branch block). These conditions may be temporarily worsened when Adenosina Hikma is administered.

• you have a very slow heart rate (severe bradycardia), respiratory failure, a potentially fatal heart rhythm (asystole), severe chest pain (angina), or very low blood pressure (severe hypotension), in which case treatment with Adenosina Hikma must be stopped.

• you have a history of unstable angina (chest pain due to impaired circulation in the coronary arteries) not adequately controlled by medical therapy.

Patients who develop high-grade AV (atrioventricular) block should not receive
further dose increases.
Your doctor will stop treatment with adenosine if you experience any
serious adverse effects.
If you are not sure whether any of the above conditions apply to you, consult your doctor or
nurse before receiving Adenosina Hikma.
Children and adolescents
In children with a heart rhythm disorder called "Wolff-Parkinson-White (WPW) syndrome", Adenosina Hikma may cause an unexpected, severely abnormal heart rhythm.
If you are not sure whether this applies to your child, consult your doctor or nurse
before your child receives Adenosina Hikma.
Patients with kidney and/or liver disease
Since exogenous (administered) adenosine is not metabolized either renally or hepatically, the efficacy and tolerability of Adenosina Hikma should not be affected by hepatic or renal impairment.
Other medicines and Adenosina Hikma
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal preparations.
This is because Adenosina Hikma may affect how other medicines work.
Some medicines may also affect how Adenosina Hikma works.
In particular, check with your doctor or nurse if you are taking any of the following medicines:

• Dipyridamole (a medicine used to thin the blood). Make sure your doctor knows you are taking dipyridamole. Your doctor may decide not to administer Adenosina Hikma, or may instruct you to stop taking dipyridamole 24 hours before receiving Adenosina Hikma, or may need to use lower doses of Adenosina Hikma.
• Aminophylline or theophylline (medicines used to help you breathe). Your doctor may instruct you to stop taking these 24 hours before administration of Adenosina Hikma.
• Caffeine (sometimes found in headache medicines).
• Adenosina Hikma may interact with other drugs that inhibit conduction (e.g. beta-blockers, digoxin, verapamil) or that enhance conduction (e.g. beta-sympathomimetics).

Adenosina Hikma with food, drinks and alcohol
Foods and drinks containing caffeine such as tea, coffee, chocolate and cola-based beverages
should be avoided for at least 12 hours before administration of Adenosina Hikma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or nurse for advice before taking this medicine.
Pregnancy
Adenosina Hikma should not be administered to you if you are pregnant or suspect you are pregnant, unless clearly necessary.
Breastfeeding
Adenosina Hikma should not be administered to you if you are breastfeeding.
Driving and using machines
Data not known.
Adenosina Hikma contains Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially "sodium-free".

3. How to use Adenosina Hikma

• Adenosina Hikma is a hospital medicine used in hospitals equipped with resuscitation equipment readily available.
• It will be administered to you by a doctor or nurse as an intravenous injection.
• Your heart and blood pressure will be closely monitored.

If you are unsure why you are being given Adenosina Hikma or have any questions about
how much Adenosina Hikma you are receiving, please consult your doctor or nurse.
The recommended dose (in adults and elderly patients) is:

• The first dose is 3 mg given over 2 seconds. This will be administered to you as a rapid intravenous injection.
• If the first dose does not restore your heartbeat to normal, a second dose will be given. The second dose is 6 mg administered as a rapid injection.
• If the second dose does not restore your heartbeat to normal, a third dose will be given. The third dose is 12 mg administered as a rapid injection.
• After the 12 mg dose, no further doses should be given.

Diagnostic use:
The above-mentioned escalating dose regimen should be used until sufficient diagnostic information has been obtained.

Use in children and adolescents
Adenosina Hikma is a hospital medicine used in hospitals equipped with resuscitation equipment readily available. The doctor will decide whether this medicine is necessary, how much should be given based on the child's weight, and whether multiple injections are required.

• Your child will be closely monitored, including through recording of the heart's electrical activity using an ECG (electrocardiogram) machine.
• The medicine will be administered to your child by a doctor or nurse as an intravenous injection.

If you receive more Adenosina Hikma than you should
Since this medicine will be administered by a doctor or nurse, it is unlikely that you will receive too much. The doctor will carefully assess the required amount of medicine.
If you receive more medicine than you should, the following effects may occur:

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

The doctor will monitor your heart throughout the procedure.
Because adenosine remains in the bloodstream for a very short time, any adverse effects of Adenosina Hikma should resolve quickly once the injection is stopped.
Sometimes an injection of a medicine called aminophylline or theophylline may be needed to help manage some of the adverse effects.
If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
While you are being given Adenosine Hikma, you may experience the following side effects.
Side effects usually resolve within a few seconds or minutes after the injection has
ended, but you must inform the doctor or nurse if any side effect occurs.
If any of the following side effects worsen, inform the doctor or
nurse, and they may stop the injection.

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

• Flushing of the skin with a burning sensation (hot flushes)
• Slow heartbeat (bradycardia)
• Missed heartbeats or extra heartbeats
• A heart problem called atrioventricular block
• Transient and self-limiting cardiac problems (asystole)
• Shortness of breath or the need to breathe deeply (dyspnea)
• Chest pain or pressure

Common (may affect up to 1 in 10 people)

• Dizziness or lightheadedness
• Feeling unwell (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous

Uncommon (may affect up to 1 in 100 people)

• Blurred vision
• Awareness of heartbeat and feeling it fast
• Metallic taste in the mouth
• Breathing faster and deeper than normal (hyperventilation)
• Increased pressure in the skull
• General feeling of discomfort, weakness or pain
• Sweating

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

• Severe shortness of breath or breathing problems
• Redness, pain or swelling at the injection site
• Feeling of discomfort during injection
• Worsening of high pressure affecting the brain (increased intracranial pressure)
• Very slow, fast or irregular heartbeats
• Very slow heartbeat (severe bradycardia)

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

• Severe heart problems that may be fatal (asystole) or irregular heartbeats
• Fainting
• Seizures (convulsions)
• Feeling unwell (vomiting)
• Breathing stops (respiratory arrest)
• Hypotension, sometimes severe
• Stroke/transient ischaemic attack; secondary to the haemodynamic effects of adenosine, including hypotension
• Anaphylactic reaction (including angioedema and skin reactions such as urticaria and rashes)
• Myocardial infarction/ST segment elevation, especially in patients with severe pre-existing coronary artery disease

If any of the side effects listed above worsen, inform the
doctor or nurse, who may stop the injection.
Side effects usually resolve within a few seconds or minutes after the injection has
ended, but you must inform the doctor or nurse if any
side effect occurs.

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pack and vial after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate.
The product is for single use only and must be used immediately after opening. Any unused portion of the vial contents must be discarded.
Do not use this medicine if you notice the presence of particles or changes in colour before administration.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Adenosina Hikma contains

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

Each 2 ml vial of Adenosina Hikma contains 6 mg of adenosine.
Each ml of injectable solution contains 3 mg of adenosine.

Description of the appearance of Adenosina Hikma and contents of the pack
Adenosina Hikma is a sterile, clear, colourless, particle-free injectable solution.
Each pack contains 10 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Hikma Farmacêutica (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

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy Adenosina Hikma
Austria Adenosin Hikma 6 mg/2 ml Injektionslösung
Belgium Adenosine Hikma 6 mg/2 ml Injektionslösung /
Solution injectable / Oplossing voor injectie
France Adenosine Hikma 6 mg/2 ml, solution injectable
Germany Adenosin Hikma 6 mg/2 ml Injektionslösung
Netherlands Adenosine Hikma, 6 mg/2 ml, Oplossing voor injectie
Portugal Adenosina Hikma
United Kingdom/Ireland Adenosine, 6 mg/2 ml, Solution for injection
Spain Adenosina Hikma, 6 mg/2 ml, Solución inyectable

The following information is intended for healthcare professionals only:

• Dosage and administration

Adenosine Hikma is intended for hospital use in hospitals equipped with monitoring and cardiopulmonary resuscitation facilities immediately available.
Dosage
Adults
Initial dose: 3 mg administered as a rapid intravenous bolus (within 2 seconds).
Second dose: if the first administration does not suppress supraventricular tachycardia within 1 or 2 minutes, a further dose of 6 mg should be administered as a rapid intravenous bolus.
Third dose: if the second administration does not suppress supraventricular tachycardia within 1 or 2 minutes, 12 mg should be administered as a rapid intravenous bolus.
Additional or higher doses are not recommended.
Paediatric population
Cardiopulmonary resuscitation equipment must be immediately available during adenosine administration.
Adenosine Hikma must be administered with continuous ECG monitoring and recording.
The recommended dosing regimen for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:

• initial bolus of 0.1 mg/kg body weight (maximum dose 6 mg)
• increase by 0.1 mg/kg body weight as needed to terminate paroxysmal supraventricular tachycardia (maximum dose 12 mg).

Elderly
See recommended adult doses.
Method of administration
Adenosine Hikma must be administered by rapid intravenous bolus injection according to the dosing regimen described above. To ensure that the solution reaches the systemic circulation, administer directly into a vein or intravenous line. If administered through an intravenous line, the medication should be injected as proximally as possible and followed immediately by a rapid saline flush. When administered via a peripheral vein, a large-bore cannula should be used.
Adenosine Hikma should only be used when cardiac monitoring facilities are available. Patients who develop high-grade AV block should not receive further dose increments.
Dose for diagnostic use
The above-mentioned escalating dose regimen should be used until sufficient diagnostic information is obtained.

• Incompatibilities

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

• Special precautions for disposal and handling

No special precautions.
Any unused medicinal product or waste material should be disposed of in accordance with local applicable regulations.