Leaflet: information for the user

Adenosina Accord 30 mg/10 ml, solution for infusion EFG

Adenosina

Read this leaflet carefully before starting to use the medicine.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or nurse.

- This medicine has been prescribed for you only and should not be given 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.

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

2. What you need to know before you receive Adenosina Accord

3. How Adenosina Accord is administered

4. Possible side effects

5. Storage of Adenosina Accord

6. Contents of the pack and additional information

Adenosina Accord contains an active ingredient called adenosine. This belongs to a group of medications called “coronary vasodilators”.

This medication is only for diagnostic use.

Adenosina Accord is used before a test called “myocardial perfusion imaging” that helps visualize your heart. During this test, they will give you a medication called “radiopharmaceutical”.

Adenosina Accord works by widening the blood vessels of the heart, allowing blood to flow more freely. This allows the “radiopharmaceutical” medication to access your heart. The doctor can visualize your heart and evaluate its conditions. This procedure is used if you cannot exercise or if it is not possible to perform a stress test.

Do not use this medicine and inform your doctor if:

- You are allergic to adenosine or to any of the other components of this medicine (listed in section 6).

- You have symptoms of an allergic reaction that include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

- You have severe low blood pressure (hypotension).

- You have unstable angina that is not being treated with medication.

- You have asthma or other severe respiratory problems.

- You are taking a medication called dipiridamol used to thin the blood.

- You have a type of heart failure in which your heart cannot pump enough blood.

- You have problems with your heart rhythm and do not have an implanted pacemaker (second and third degree of atrioventricular block, sinoatrial disease).

- You have been told that you have the "long QT interval syndrome". It is a heart problem that appears in rare cases and can cause a rapid heartbeat and fainting.

Do not use this medicine if any of the contraindications affect you. If you are unsure, consult with your doctor or nurse before using Adenosina Accord.

Warnings and precautions

Consult with your doctor or nurse before using Adenosina Accord if:

- You have low blood volume (hypovolemia) and it is not adequately corrected with medication treatment.

- 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 artery). This means that not enough blood is reaching the brain (cerebrovascular insufficiency).

- You have had or have had seizures or convulsions.

- You have difficulty breathing (bronchospasm).

- You have a heart disease caused by narrowing of your heart valves (valvular stenosis).

- You have inflamed membrane surrounding your heart (pericarditis) or accumulation of fluid around your heart (pericardial effusion).

- You have a heart defect in which the blood passes directly from the left to the right side of your heart.

- You have narrowing of the main left coronary artery that supplies blood to the heart (left main coronary artery stenosis).

- You have or have had a heart attack, severe heart failure, or if you have had a heart transplant in the last year.

- You have a rare heart rhythm. For example, your heartbeat is very fast or irregular (atrial fibrillation or flutter) and particularly if you have an "accessory conduction pathway".

- You have a minor heart problem (first degree of atrioventricular block or branch block). These conditions may worsen temporarily when you are given Adenosina Accord.

Consult with your doctor immediately if:

Experience signs of stroke. This can present as sudden numbness or weakness in the face, arms, or legs. Other signs would be feeling confused, problems with vision, walking, coordination, or balance, difficulty speaking, or difficulty speaking.

Experience signs of heart attack (myocardial infarction). Severe chest pain is the most common main symptom. The pain can also go to the jaw and down to your left arm or to both arms. You may also sweat, feel nauseous, and feel dizzy. A small heart attack (myocardial infarction) occasionally occurs without causing pain (a "silent myocardial infarction"). It can be really painless, or, sometimes, the pain is mild and you may think it's just acid reflux or "gas".

If you are unsure of whether something mentioned above applies to you, consult with your doctor or nurse before using Adenosina Accord.

Children and adolescents

Adenosina Accord has not been sufficiently studied in children and adolescents.

Other medicines and Adenosina Accord

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medicines. This includes medicines that can be bought without a prescription, including herbal medicines. This is because Adenosina Accord may affect how some medicines work. Also, some medicines may affect how Adenosina Accord works.

In particular, check with your doctor or nurse if you are taking any of the following:

- Dipiridamol (medicine used to thin the blood). Make sure your doctor knows that you are taking dipiridamol. Your doctor may tell you to stop taking dipiridamol 24 hours before Adenosina Accord is administered or that a lower dose of Adenosina Accord is administered.

- Aminophylline, theophylline, or other xanthines (medicines used to help you breathe). Your doctor may tell you to stop taking them 24 hours before Adenosina Accord is administered.

Adenosina Accord with food and drinks

You should avoid foods or drinks that contain xanthines, such as tea, coffee, chocolate, and cola for at least 12 hours before Adenosina Accord is administered.

Pregnancy and breastfeeding

Consult with your doctor or nurse before using this medicine if:

- You are pregnant, could become pregnant, or think you might be pregnant. Adenosina Accord should not be administered unless it is clearly necessary.

- You are breastfeeding. Adenosina Accord should not be administered.

If you are pregnant or breastfeeding, consult with your doctor or nurse before using any medicine.

Important information about some of the excipients of Adenosina Accord

Sodium:

Adenosina Accord 30 mg/10 ml contains sodium.This medicine contains 0.15 mmol (3.54 mg) of sodium per ml.

How to Use Adenosina Accord

- Adenosina Accord is a hospital-use medication.

- You will be administered by a doctor or nurse. It will be administered through a vein for a period of time (this is called intravenous perfusion).

- Your heart and blood pressure will be closely monitored.

What amount of Adenosina Accord is administered

If you are unsure why you are being administered Adenosina Accord or have questions about the amount being administered, ask your doctor or nurse.

Adults (including elderly patients)

- The dose is calculated according to your body weight.

- The usual dose is 140 micrograms per kilogram of body weight, per minute. It is administered over a period of 6 minutes through a perfusion pump (slow intravenous injection).

- The Adenosina Accord dose does not change if you have liver or kidney problems.

If you have received more Adenosina Accord than you should have

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 Adenosina Accord you should receive.

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

- Very low blood pressure (severe hypotension).

- Slow heart rate (bradycardia).

- A heart problem (asystole).

Your doctor will continuously monitor your heart during the process.

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

If you have more questions about the use of this medication, consult your doctor or nurse.

Like all medications, Adenosina Accord may cause side effects, although not everyone will experience them. While receiving Adenosina Accord, you may have one of the following side effects.

If any of the following side effects worsen, inform your doctor or nurse immediately and they will decide whether you should continue with the infusion or not.

Side effects usually resolve in a few seconds or minutes after the infusion has ended, but you should inform your doctor or nurse if you experience any of them.

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

• Redness of the skin with a sensation of heat (flushing).
• Lack of breathing or need to breathe deeply (dyspnea).
• Headache.
• Chest pain or pressure in the chest.
• Abdominal discomfort.

Common (may affect up to 1 in 10 patients)

• Sensation of dizziness or headache caused by light.
• Rare sensations in the skin such as lack of touch, tingling, itching, burning, or gradual numbness (paresthesia).
• Low blood pressure.
• A heart problem called atrioventricular block.
• Rapid or irregular heartbeats (cardiac arrhythmias).
• Dry mouth.
• Discomfort in the throat, jaw, or neck.

Uncommon (may affect up to 1 in 100 patients)

• Metallic taste in the mouth.
• Sweating.
• Discomfort in the legs, arms, or back.
• Sensation of weakness or pain or general discomfort.
• Nervous sensation.
• Slow heart rate (bradycardia).

Rare (may affect up to 1 in 1,000 patients)

• Difficulty breathing (bronchospasm).
• Stuffy nose.
• Sensation of drowsiness.
• Blurred vision.
• Tinnitus (ringing in the ears).
• Sudden need to urinate.
• Discomfort in the nipples.
• Trembling.

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

• Severe lack of breathing or breathing difficulties.
• Redness, pain, or swelling at the injection site.

Other side effects (frequency cannot be estimated from available data)

• Allergic reactions including swelling of the face or throat, and skin reactions such as urticaria or skin rash.

• Severe heart problems that may cause death (asystole) or irregular heartbeats.
• Seizures.
• Loss of consciousness.
• Lack of breathing (apnea).

Sensation of dizziness (nausea) or dizziness (vomiting).

If any of the following side effects worsen, inform your doctor or nurse immediately and they will decide whether you should continue with the infusion or not. Side effects usually resolve in a few seconds or minutes after the infusion has ended, but you should inform your doctor or nurse if you experience any of them.

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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Your doctor, nurse, or hospital pharmacist will store this medication in a safe place where children cannot see it or reach it.

Adenosina Accord should not be used after the expiration date that appears on the packaging and on the vial label. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not refrigerate.

This product is for single use and once opened, it should be used immediately. Any fraction of the vial that is not used should be eliminated immediately.

Do not use Adenosina Accord if your doctor or nurse notes any particles in the solution, or any discoloration before administration. If the product's appearance has changed, the vial should be discarded.

Medications should not be thrown down the drain or in the trash. This will help protect the environment.

Composition of Adenosina Accord

- The active principle is adenosine. Each ml of injectable solution contains 3 mg of adenosine. Each vial of 10 ml contains 30 mg of adenosine.

- The other components are sodium chloride and water for injectable preparations.

Appearance of the product and content of the container

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

Each container contains 6 vials conditioned in a PVC tray in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing:

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

This medicinal product is authorized in the Member States of the EEA under the following names:

Last review date of this leaflet: March 2019

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