• Keep this leaflet You may need to read it again
• If you have any further questions, ask your doctor
• 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.

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

• During a test. This is to help doctors find out what type of arrhythmia (uneven heart beat) you have
• To bring your heart beat back to normal if you have a type of arrhythmia called ‘paroxysma supraventricular tachycardia (SVT)’ or ‘Wolff-Parkinson-White Syndrome’

• To bring your child’s heart beat back to normal if your child have a type of heart rhythm trouble called ‘paroxysmal supraventricular tachycardia’ (PSVT)

• You are allergic (hypersensitive) to adenosine or any of the other ingredients of Adenosine (listed in section 6 below).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of you lips, face, throat or tongue
• You have asthma or any other severe breathing problem
• You have very low blood pressure (severe hypotension)
• 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 pace maker (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 heart beat and fainting

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

Talk to your doctor or nurse before taking Adenosine if:

• You have a certain type of unusual heart rhythm (atrial fibrillation or atrial flutter) and in particular if you have an ‘accessory conduction pathway’
• You have been told that you have a heart problem whereby the electrical impulses in parts of your heart take longer than normal to discharge and then recharge (prolonged QT interval)
• 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 insuffciency)
• 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 any minor problem with your heart (first degree AtrioVentricular block or bundle branch block). These conditions may be temporarily aggravated when you are given Adenosine

If you get a very slow heartbeat (severe bradycardia), respiratory failure, a heart problem that can be fatal (asystole), severe chest pains (angina) or very low blood pressure (severe hypotension), then treatment with Adenosine should be stopped.

In children with a heart rhythm trouble called ‘Wolff-Parkinson-White (WPW) syndrome’, Adenosine bolus may cause some unexpected severely abnormal heart rhythm.

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

Please tell your doctor, nurse or pharmacist 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 Adenosine can affect the way some other medicines work. Also some medicines can affect the way Adenosine works.

In particular, check with your doctor, nurse or pharmacist 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 decide you should not have Adenosine or may tell you to stop taking dipyridamole 24 hours before you are given Adenosine or may need to give you a lower dose of Adenosine
• Aminophylline or theophylline (medicines used to help breathing) Your doctor may tell you to stop taking it 24 hours before you are given Adenosine
• Caffeine (sometimes found in headache medicines)

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

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 Adenosine if you are pregnant or think you may be pregnant, unless clearly necessary
• You are breast-feeding. You should not be given Adenosine if you are breast-feeding Ask you doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.

Not relevant. There are no known effects on driving and using machines.

Adenosine contains 3.542 mg sodium per ml (7.08 mg sodium per 2 ml vial).This should be taken into consideration by patients on a controlled sodium diet.

• Adenosine is a medicine for use in hospitals
• It will be given to you by a doctor or nurse as an injection into your vein
• Your heart and blood pressure will be closely monitored
  Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Adults (including the elderly)

• The first dose is 3mg given over 2 seconds. This is given by rapid injection into your Vein
• If the first dose does not bring your heart beat to normal then you will be given a second dose. The second dose is 6 mg given as a rapid injection
• If the second dose does not bring your heart beat to normal then you will be given a third dose: The third dose is 12mg given as a rapid injection
• You should not have any more doses after the 12mg dose

Adenosine bolus is a medicine for use in hospitals with resuscitation equipment available

Your doctor will decide if this medicine is needed, how much should be given depending on your child’s weight, and if several injections are needed.

• Your child will be closely monitored, including recording of his/her heart’s electrical activity using an ECG (electrocardiogram) machine
• It will be given as an injection into your child vein by a doctor or nurse

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 Adenosine 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 Adenosine would quickly stop when the injection is stopped. Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects.

The side effects normally settle within seconds or minutes after the injection is finished but you should tell your doctor or nurse if any of them happen.

Very common (affects more than 1 in 10 people)

• Reddening of skin with a feeling of heat (flushing)
• Slow heartbeat (bradycardia)
• Skipped heart beats or extra heartbeats
• A heart problem called an AV block
• Severe heart problems which can be fatal (asystole) or uneven heartbeat
• Shortness of breath or the urge to breathe deeply (dyspnoea)
• Chest pain or pressure on the chest

Common (affects up to 1 in 10 people)

• Feeling dizzy or light-headed
• Feeling sick (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous

Uncommon (affects up to 1 in 100 people)

• Blurred vision
• Being aware of your heartbeat or feeling it ‘racing’
• Metallic taste in your mouth
• Breathing more quickly or more deeply than normal (hyperventilation)
• Feeling pressure in your head, or weighed down in your arms
• Feeling of general discomfort, weakness or pain
• Sweating

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

• Severe breathlessness or problems in breathing
• Redness, pain or swelling at the site of injection
• Feeling uncomfortable during the injection
• Worsening of high blood pressure that affects the brain (intracranial hypertension)
• Very slow, fast or uneven heartbeats
• Severe bradycardia (very slow heartbeat)

• Allergic reactions including swelling of the face or throat, and skin reactions such as hives or rash
• Fainting
• Fits (convulsions)
• Being sick (vomiting)
• Stopping breathing (respiratory arrest)

If any of the above side effects get worse, tell your doctor or nurse and they may stop the injection. The side effects normally settle within seconds or minutes after the injection is finished but you should tell your doctor or nurse if any of them happen.

If you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via the Yellow Card Scheme at : www.mhra.gov.uk/yellowcard

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

• The active substance is adenosine.
  Each ml of solution for injection contains 3 mg adenosine
  Each 2ml vial contains 6mg of adenosine.
• The other ingredients are sodium chloride and water for injections.

Adenosine is a clear and colourless to almost colourless solution, free from visible particle.

Each pack contains 5, 6, 10 and 25 vials.

Not all packs may be marketed.