Adenosine 30mg/10ml 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 Adenosine Infusion is and what it is used for
2. Before you are given Adenosine Infusion
3. How you will be given Adenosine Infusion
4. Possible side effects
5. How to store Adenosine Infusion
6. Further information

• are allergic (hypersensitive) to adenosine or to any of the other ingredients in 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
• have very low blood pressure (severe hypotension)
• have unstable angina which is not controlled by treatment with medicine
• have asthma or any other severe breathing problem
• are taking a medicine called dipyridamole (used to thin the blood)
• have a type of heart failure where your heart is not pumping out enough blood
• have problems with your heart rhythm and do not have a pacemaker (second or third degree atrioventricular block, sick sinus syndrome)
• 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 Infusion.

Check with your doctor or nurse before you have Adenosine Infusion if you have:

• low blood volume (hypovolaemia) that is not adequately corrected by treatment with medicines
• problems with a part of your nervous system called the ‘autonomic nervous system’.
• narrowing of the main arteries in the neck (carotid artery). This means that not enough blood is getting to the brain (cerebrovascular insufficiency)
• or have ever had fits or convulsions
• difficulty in breathing (bronchospasm)
• heart disease due to narrowing of your heart valves (stenotic valvular heart disease)
• inflammation of the membrane surrounding your heart (pericarditis) or a build-up of the fluid around your heart (pericardial effusion)
• a left-right shunt in your heart. This will mean blood goes directly from the left side of your heart to the right side
• narrowing of the left main artery supplying blood to your heart (left main coronary stenosis)
• had a recent heart attack, severe heart failure or you have had a heart transplant in the last year
• 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’)
• 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 Infusion.

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 Adenosine Infusion.

Adenosine Infusion use in children and adolescents has not been sufficiently studied

Please tell your doctor or nurse if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Adenosine Infusion can affect the way some other medicines work. Also some medicines can affect the way Adenosine Infusion 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 Adenosine Infusion or you may be given a much lower dose of Adenosine Infusion
• Aminophylline, theophylline or other xanthines (medicines used to help breathing). Make sure you tell your doctor you are taking any of these medicines. Your doctor may tell you to stop taking them 24 hours before you are given Adenosine Infusion.

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

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

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.

This medicinal product contains approximately 36mg sodium per vial (10ml). This should be taken into consideration by patients on a controlled sodium diet.

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

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

As 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 Infusion you should be given.

• 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 infusion 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 infusion is finished but you should tell your doctor or nurse if any of them happen.

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

• Reddening of the skin with a feeling of heat (flushing)
• Shortness of breath or the urge to breathe deeply (dyspnoea)
• Headache
• Chest pain or pressure on the chest
• Abdominal discomfort.

Common (may affect up to 1 in 10 people)

• Feeling dizzy, or light-headed
• Unusual skin sensations such as numbness, tingling, prickling, burning or creeping on the skin (paraesthesia)
• Low blood pressure
• A heart problem called an atrioventricular block
• Fast or irregular heartbeat (disorders of cardiac rhythm)
• Dry mouth
• Discomfort in throat, jaw or neck.

Uncommon (may affect up to 1in 100 people)

• Metallic taste in your mouth
• Sweating
• Discomfort in leg, armor back
• Feeling of weakness or pain, or of general discomfort
• Feeling nervous
• Slow heartbeat (bradycardia).

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

• Difficulty in breathing (bronchospasm)
• Blocked nose
• Feeling drowsy
• Blurred vision
• Ringing in the ear (tinnitus)
• Feeling a sudden need to urinate
• Nipple discomfort
• Tremors.

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

• Severe breathlessness or problems in breathing
• Redness, pain or swelling at the site of injection.

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 which can be fatal (asystole) or uneven heartbeat
• Fits (convulsions)
• Fainting
• Stopping breathing (respiratory arrest)
• Feeling sick (nausea) or being sick (vomiting)
• Spasm of the artery in the heart which may lead to a heart attack.

If any of the above side effects get worse, tell your doctor or nurse immediately and they will decide if you should continue the infusion or not. The side effects normally settle within seconds or minutes after the infusion is finished but you should tell your doctor or nurse if any of them happen.

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 10ml vial contains 30mg of adenosine (3mg/ml).

The other ingredients are sodium chloride and water for injections.

Adenosine is a clear, colourless solution for infusion.

Adenosine 30mg/10ml Solution for Infusion is available in packs of 6 single use glass vials.

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Product name Reference number

Adenosine 30mg/10ml Solution for Infusion PL 29831/0456

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