Adenoscan

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or nurse.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1. What Adenoscan is and what it is used for
2. Before you are given Adenoscan
3. How Adenoscan is given
4. Possible side effects
5. How to store Adenoscan
6. Further information

Do not have this medicine and tell your doctor if:

• You are allergic (hypersensitive) to adenosine or any of the other ingredients of Adenoscan (listed in section 6 below).
  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 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 or nurse before you are given Adenoscan.

Take special care with 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

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

Taking or using other medicines

Please tell your doctor or nurse if you are taking or have recently taken 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

Taking Adenoscan with food and drink

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.

Pregnancy and breast-feeding

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.

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

If you are below 18 years of age

Adenoscan use in children and adolescents has not been studied.

Important information about some of the ingredients of Adenoscan

Sodium: Adenoscan contains 35.4 mg sodium per infusion vial (10 ml). You may receive up to 0.99 mg of sodium per kilogram of body weight.This should be taken into consideration by patients on a controlled sodium diet.

How Adenoscan is given

• Adenoscan is a medicine for use in hospitals
• It will be given to you by a doctor or nurse as an injection. The injection will be into one of your veins and be given over a period of time (this is called an intravenous infusion)
• Your heart and blood pressure will be closely monitored

How much Adenoscan is given

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

If you have more Adenoscan than you should

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 any of the following 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.

Very common (affects more than 1 user in 10)

• Reddening of 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 (affects less than 1 user in 10)

• 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 (affects less than 1 user in 100)

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

Rare (affects less than 1 user in 1000)

• 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 (affects less than 1 user in 10 000)

• 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)

• 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)

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.

What Adenoscan contains

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

What Adenoscan looks like and contents of the pack

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer: