ADENOSINE ACCORD 30 mg/10 mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Adenosine Accord 30 mg/10 ml, Solution for Infusion EFG

Adenosine

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

5 Storage of Adenosine Accord

1. Contents of the pack and further information

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

Adenosine Accord contains the active substance adenosine. This belongs to a group of medicines called “coronary vasodilators”.

This medicine is for diagnostic use only.

Adenosine Accord is used before a test called “myocardial perfusion imaging” which is used to visualize your heart. During this test, you will be given a medicine called a “radiopharmaceutical”.

Adenosine Accord works by widening the blood vessels of the heart, allowing blood to flow more freely. This allows the “radiopharmaceutical” medicine to reach your heart. Your doctor can then visualize your heart and assess its condition. This procedure is used if you are unable to exercise or if a stress test is not possible.

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

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).

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

• You have very low blood pressure (severe hypotension).
• You have unstable angina that is not being treated with medicines.
• You have asthma or other severe respiratory problems.
• You are taking a medicine called dipyridamole used to thin the blood.

You have a type of heart failure where your heart is unable to pump enough blood.

• You have problems with your heart rhythm and do not have a pacemaker implanted (second or third degree atrioventricular block, sick sinus syndrome).

You have been told that you have the “long QT syndrome”. This is a heart problem that occurs rarely and can cause a fast and irregular heartbeat and fainting.

Do not use this medicine if any of the above applies to you. If you are not sure, consult your doctor or nurse before using Adenosine Accord.

Warnings and precautions

Tell your doctor or nurse before you are given Adenosine Accord if:

• You have low blood volume (hypovolemia) and it is not corrected with 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 your brain (cerebrovascular insufficiency).
• You have had seizures or fits.
• You have difficulty breathing (bronchospasm).
• You have a heart condition caused by narrowing of your heart valves (valvular stenosis).
• You have inflammation of the membrane surrounding your heart (pericarditis) or fluid accumulation around your heart (pericardial effusion).
• You have a heart condition where blood flows directly from the left side to the right side of your heart (left to right shunt).
• You have narrowing of the main artery that supplies blood to your heart (left main coronary artery stenosis).
• You have had a heart attack, severe heart failure or a heart transplant in the last year.
• You have an irregular heartbeat. For example, your heartbeat is very fast or irregular (atrial fibrillation or atrial flutter) and in particular if you have an “accessory conduction pathway”.
• You have a minor heart problem (first degree atrioventricular block or bundle branch block). These conditions may worsen temporarily when you are given Adenosine Accord.

Tell your doctor immediately if:

You experience signs of a stroke. This can appear as sudden numbness or weakness in your face, arms or legs. Other signs may include feeling confused, problems with your vision, walking, coordination or balance, problems speaking or difficulty swallowing.

You experience signs of a heart attack (myocardial infarction). Severe chest pain is the most common symptom. The pain may also spread to your jaw and down your left arm or to both arms. You may also sweat, feel nauseous and feel dizzy. A small heart attack (myocardial infarction) may occasionally occur without causing pain (a “silent myocardial infarction”). It may be truly painless, or the pain may be mild and you may think it is just heartburn or “gas”.

If you are not sure if any of the above applies to you, consult your doctor or nurse before using Adenosine Accord.

Children and adolescents

The use of Adenosine Accord has not been studied sufficiently in children and adolescents.

Other medicines and Adenosine Accord

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription, including herbal remedies. This is because Adenosine Accord may affect the way some medicines work. Also, some medicines may affect the way Adenosine Accord works.

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

• Dipyridamole (a medicine used to thin the blood). Make sure your doctor knows that you are taking dipyridamole. Your doctor may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Accord or to give you a lower dose of Adenosine Accord.
• Aminophylline, theophylline or other xanthines (medicines used to help you breathe). Your doctor may tell you to stop taking these 24 hours before you are given Adenosine Accord.

Adenosine Accord with food and drink

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

Pregnancy and breastfeeding

Consult your doctor or nurse before using this medicine if:

• You are pregnant, might be pregnant or are planning to become pregnant. Adenosine Accord should not be given to you unless it is clearly necessary.
• You are breastfeeding. You should not be given Adenosine Accord.

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

Important information about some of the ingredients of Adenosine Accord

Sodium:

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

3. How to use Adenosine Accord

How to use Adenosine Accord

• Adenosine Accord is a hospital-only medicine.
• It will be given to you by a doctor or nurse. It will be given to you through a vein over a period of time (this is called intravenous infusion).
• Your heart and blood pressure will be closely monitored.

How much Adenosine Accord is given

If you are not sure why you are being given Adenosine Accord or have questions about the amount you are being given, 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 given over a period of 6 minutes through an infusion pump (slow injection into a vein).
• The dose of Adenosine Accord does not change if you have liver or kidney problems.

If you have been given too much Adenosine Accord

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

If you are given too much medicine, you may experience the following effects:

• Very low blood pressure (severe hypotension).
• Slow heartbeat (bradycardia).
• A heart problem (asystole).

Your doctor will continuously monitor your heart during the procedure.

As the time that adenosine stays in the blood is very short, any side effects due to an overdose of Adenosine Accord will stop quickly when the infusion 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 further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Adenosine Accord can cause side effects, although not everybody gets them. While you are receiving Adenosine Accord, you may experience one of the following side effects.

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

Side effects usually go away within a few seconds or minutes after the infusion has finished, but you should tell your doctor or nurse if you experience any of them.

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

• Flushing of the skin with a feeling of warmth (flushing).
• Shortness of breath or need to breathe deeply (dyspnea).
• Headache.
• Chest pain or pressure in the chest.
• Abdominal discomfort.

Common (may affect up to 1 in 10 people)

• Feeling of dizziness or lightheadedness caused by light.
• Unusual sensations in the skin such as numbness, tingling, itching, burning or gradual tingling (paresthesia).
• Low blood pressure.
• A heart problem called atrioventricular block.
• Fast or irregular heartbeats (arrhythmias).
• Dry mouth.
• Discomfort in the throat, jaw or neck.

Uncommon (may affect up to 1 in 100 people)

• Metallic taste in the mouth.
• Sweating.
• Discomfort in the legs, arms or back.
• Feeling of weakness or pain or general discomfort.
• Feeling nervous.
• Slow heartbeat (bradycardia).

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

• Difficulty breathing (bronchospasm).
• Nasal congestion.
• Feeling of drowsiness.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Sudden need to urinate.
• Discomfort in the nipples.
• Tremors.

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

• Severe difficulty breathing or breathing problems.
• Redness, pain or swelling at the injection site.

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

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

• Severe heart problems that can cause death (asystole) or irregular heartbeats.
• Seizures (fits).
• Fainting.
• Stopping breathing (respiratory arrest).

Feeling of nausea (nausea) or vomiting (vomiting).

If any of the above side effects get worse, tell your doctor or nurse immediately and they will decide whether you should continue with the infusion or not. Side effects usually go away within a few seconds or minutes after the infusion has finished, but you should tell your doctor or nurse if you experience any of them.

Reporting of side effects:

If you experience any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adenosine Accord

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

Adenosine Accord should not be used after the expiry date which is stated on the carton and vial label. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Do not refrigerate.

This product is for single use only and once opened should be used immediately. Any unused portion of the vial should be discarded immediately.

Adenosine Accord should not be used if your doctor or nurse notices any particles in the solution or any coloration before administration. If the appearance of the product has changed, the vial should be discarded.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and further information

Composition of Adenosine Accord

• The active substance is adenosine. Each ml of injectable solution contains 3 mg of adenosine. Each 10 ml vial contains 30 mg of adenosine.
• The other ingredients are sodium chloride and water for injections.

Appearance and packaging

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

Each pack contains 6 vials packaged in a PVC tray in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer:

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

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

Date of last revision of this leaflet: March 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es