Adenoscan 30 mg/10 ml, solution for infusion

• 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.

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

• You are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have very low blood pressure (severe hypotension).
• You have unstable angina which is not controlled by treatment with medicine.
• You have asthma or any other severe breathing problem.
• You are taking a medicine called dipyridamole used to thin the blood.
• You have a type of heart failure where your heart is not pumping out enough blood.
• You have problems with your heart rhythm and do not have a pacemaker (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 a fast heartbeat and fainting.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Adenoscan.

Check with your doctor or nurse before you have Adenoscan if:

• You have low blood volume (hypovolaemia) that is not adequately corrected by treatment with medicines.
• 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 getting to the brain (cerebrovascular insufficiency).
• You have or have ever had fits or convulsions.
• You have difficulty in breathing (bronchospasm).
• You have heart disease due to narrowing of your heart valves (stenotic valvular heart disease).
• You have inflammation of the membrane surrounding your heart (pericarditis) or a build-up of fluid around your heart (pericardial effusion).
• You have a left-right shunt in your heart.
  This will mean blood goes directly from the left side of your heart to the right side.
• You have narrowing of the left main artery supplying blood to your heart (left main coronary stenosis).
• You have had a recent heart attack, severe heart failure or you have had a heart transplant in the last year.
• You have an unusual heart rhythm. For example, your heartbeat is very fast or uneven (atrial fibrillation or atrial flutter) and in particular if you have an ‘accessory conduction pathway’.
• You have any minor problem with your heart (first-degree AtrioVentricular block or bundle branch block). These conditions may be temporarily aggravated when you are given Adenoscan.

Talk to your doctor immediately if:

• You experience signs of stroke. This may present itself as a sudden numb or weak feeling in the face, arms, or legs. Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
• You experience signs of heart attack (myocardial infarction). Severe chest pain is the usual main symptom. The pain may also travel up into your jaw, and down your left arm, or down both arms. You may also sweat, feel sick, and feel faint. A small heart attack (myocardial infarction) occasionally happens without causing pain (a ‘silent myocardial infarction’). It may be truly pain-free, or sometimes the pain is mild and you may think it is just heartburn or ‘wind’.

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

Adenoscan use in children and adolescents has not been sufficiently studied.

Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Adenoscan can affect the way some other medicines work.

Also, some medicines can affect the way Adenoscan works.

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

• Dipyridamole (medicine used to thin the blood). Make sure your doctor knows you are taking dipyridamole. Your doctor may tell you to stop taking dipyridamole 24 hours before you are given Adenoscan or you may be given a much lower dose of Adenoscan.
• Aminophylline, theophylline or other xanthines (medicines used to help breathing). Your doctor may tell you to stop taking it 24 hours before you are given Adenoscan.

Food and drinks containing xanthines such as tea, coffee, chocolate and cola should be avoided for at least 12 hours before you are given Adenoscan.

Talk to your doctor or nurse before having this medicine if:

• You are pregnant, might become pregnant, or think that you may be pregnant. You should not be given Adenoscan unless clearly necessary.
• You are breast-feeding. You should not be given Adenoscan.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

This medicine contains 35.4mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.77% of the recommended maximum daily dietary intake of sodium for an adult.

If you are not sure why you are being given Adenoscan or have any questions about how much Adenoscan is being given to you, speak to your doctor or nurse.

Adults (including the elderly)

• The dose is calculated according to your weight.
• The usual dose is 140 micrograms per kilogram of body weight, per minute. This is given over a period of six minutes through an infusion pump (a slow injection into a vein).
• The dose of Adenoscan is not changed if you have liver or kidney problems.

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 work out how much Adenoscan you should be given.

If you have more of this medicine than you should, the following effects may happen:

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

Your doctor will be monitoring your heart throughout the procedure.

As the length of time adenosine stays in the blood is very short, any side effects of too much Adenoscan would quickly stop 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is adenosine. Each 10ml vial of Adenoscan contains 30mg of adenosine (3mg per ml).
• The other ingredients are sodium chloride and sterile water for injections.

Adenoscan is a clear, sterile, colourless solution for infusion.

Each pack contains 6 single use vials of 30mg/10ml.

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