Adenosine 3mg/ml Solution for Injection

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you.
  Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

• are allergic (hypersensitive) to adenosine or to any of the other ingredients in this medicine (see section 6. Further information)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• have problems with your heart rhythm and do not have a pacemaker (second or third degree atrioventricular block, sick sinus syndrome)
• have very low blood pressure (severe hypotension)
• have asthma or any other severe breathing problem
• have a type of heart failure where your heart is not pumping out enough blood
• 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 Adenosine.

Talk to your doctor, nurse, pharmacist before you have taken Adenosine if:

• low blood volume which is not corrected by medicines
• narrowing of your left main artery supplying blood to your heart (left main coronary stenosis)
• 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)
• narrowing of the main arteries in the neck, so not enough blood is getting to the brain
• a heart disease which is caused by the narrowing of your heart valves (stenotic valvular heart disease)
• a left-right shunt in your heart, which means blood goes directly from the left side of your heart to the right side
• problems with a part of your nervous system called the autonomic nervous system
• inflammation of the membrane surrounding your heart (pericarditis) or a build-up of the fluid around your heart (pericardial effusion)
• had severe heart failure
• had a heart attack or if you have had a heart transplant in the last year
• any minor problem with your heart (first degree atrioventricular block or a bundle branch block). These conditions may be temporarily aggravated when you are given Adenosine Injection
• an unusual heart rhythm, for example your heartbeat is very fast or uneven (atrial fibrillation or atrial flutter) and in particular if you have a condition where your heart has abnormal electrical activity (’accessory conduction pathway)’
• difficulty in breathing (bronchospasm)
• ever had fits or convulsions.

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.

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

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’.

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

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Adenosine Injection:

• dipyridamole (a medicine used to thin the blood). Make sure you tell your doctor you are taking dipyridamole. Your doctor may decide you should not have Adenosine Injection or may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Injection or may need to give you a lower dose
• aminophylline or theophylline (medicines used to help breathing)
  Your doctor may tell you to stop taking it 24 hours before you are given Adenosine Injection
• caffeine (sometimes found in headache medicines).

Food and drink containing xanthines, for example tea, coffee, chocolate and cola, should be avoided for at least 12 hours before you are given Adenosine Injection.

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 Injection unless clearly necessary
• You are breast-feeding. You should not be given Adenosine Injection.

Ask your doctor or nurse for advice before taking any medicine.

This medicinal product contains approximately 7mg sodium per vial (2ml) i.e. essentially ‘sodium-free’.

The first dose is 3mg given over 2 seconds. This is given as a rapid injection into your vein. If the first dose does not bring your heartbeat to normal then you will be given a second dose. The second dose will be 6mg given as a rapid injection.

If the second dose does not bring your heart rate to normal then you will be given a third dose. The third dose is 12mg given as a rapid injection.

You will not be given any more doses after the 12mg dose.

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’s vein by a doctor or nurse.

This medicine is given to you by your doctor or nurse. It is unlikely that you will be given too much. You doctor will carefully work out how much Adenosine Injection 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.

The length of time Adenosine stays in the blood is very short.

Any side effects of too much Adenosine Injection would quickly stop when the injection is stopped. You may be given an injection of a medicine called theophylline to help with any side effects.

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for the 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 ingredient is adenosine.

Each 2ml vial contains 6mg of adenosine.

The other ingredients are sodium chloride and water for injections.

Adenosine is a clear, colourless solution for injection.

Adenosine 3mg/ml (6mg in 2ml) Solution for Injection is available in packs of 6 single use glass vials.

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Product name Reference number

Adenosine 3mg/ml (6mg in 2ml) Solution for Injection PL 29831/0457

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