Patient leaflet - Adenosine 6 mg / 2 ml solution for injection

1. WHAT ADENOSINE IS AND WHAT IT IS USED FOR

Adenosine contains a medicine called adenosine. This belongs to a group of medicines called ‘antiarrhythmics’.

Adenosine works by slowing down electrical impulses between the upper and lower chambers of the heart. This slows the fast or uneven heartbeats called ‘arrhythmias’.

Adenosine is used:

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 ‘paroxysmal supraventricular t achycardia (SVT)’ or ‘Wolff-Parkinson-White Syndrome’.

Children

In children, Adenosine is used to bring your child’s heart beat back to normal if your child has a type of heart rhythm trouble called ‘paroxysmal supraventricular tachycardia’ (PSVT).

Adenosine has been shown to be ineffective in patients with atrial or ventricular tachycardia or with tachycardia attributable to atrial ﬁbrillation or atrial ﬂutter.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADENOSINE

Do not take Adenosine:

if 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 b reathing problems, swelling of your lips, face, throat or t ongue.
if you have asthma or any other severe breathing problem.
if you have very low blood pressure (severe hypotension).
if you have heart failure where your heart is not pumping out enough blood.
if you have problems with your heart rhythm and do not have a pace maker (second or third degree Atrioventricular block, sick sinus syndrome).
if you have been told you have ‘Long QT syndrome’. This is a rare heart problem that can lead to a fast heart beat a nd fainting.

This medicine should not be given to you if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you have Adenosine.

Warnings and precautions

Talk to your doctor or nurse before you are given Adenosine if:

you have a certain type of unusual heart rhythm (atrial ﬁbrillation or atrial ﬂutter) and, in particular, if you have a n ‘accessory conduction pathway’.
you have a condition called long QT syndrome (prolonged QT interval).
you have low blood volume (hypovolemia) that is not adequately corrected by treatment.
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 g etting to the brain (cerebrovascular insufﬁciency).
you have or have ever had ﬁts or convulsions.
you have difﬁculty in breathing (bronchospasm).
you have 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 h eart (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 r ight 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 c onditions maybe temporarily aggravated when you are g iven 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 p ressure (severe hypotension), then treatment with A denosine should be stopped.
if you have unstable angina pectoris (chest pain due to impaired circulation in the coronary heart vessels) not c orrectly stabilized with medical therapy.

Patients who develop high-level AV block at a particular dose should not be given further dosage increments.

The following information is intended for healthcare professionals only:

Posology and method of administration

Adenosine is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.

Posology

Initial dose: 3 mg given as a rapid intravenous bolus (over 2 seconds). Second dose: If the ﬁrst dose does not result in elimination of the supraventricular tachycardia within 1 to

2 minutes, 6 mg should be given also as a rapid intravenous bolus. Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to

2 minutes, 12 mg should be given also as a rapid intravenous bolus.

Additional or higher doses are not recommended.

During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary.

Adenosine is intended for use with continuous monitoring and ECG recording during administration.

The dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:

ﬁrst bolus of 0.1 mg/kg body weight (maximum dose of 6 mg)
increments of 0.1 mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12 mg).

See dosage recommendations for adults. adenosine

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Adenosine 6 mg/2 ml

solution for injection

Your doctor will stop the treatment with adenosine if you experience any serious side effect.

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

Children and adolescents

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 your child, talk to your doctor or nurse before they are given Adenosine.

Patients with kidney and/or liver diseases

Since exogenous (administered) adenosine is metabolised neither via the kidneys nor the liver, the efﬁcacy and tolerability of Adenosine should be unaffected by hepatic or renal failure.

Other medicines and Adenosine

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 Adenosine can affect the way some other medicines work. Also some medicines can affect the way Adenosine works.

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

Dipyridamole (medicine used to thin the blood). Make sure your doctor knows you are taking dipyridamole. Your d octor may decide you should not have Adenosine or m ay tell you to stop taking dipyridamole 24 hours before y ou are given Adenosine or may need to give you a lower d ose of Adenosine.
Aminophylline or theophylline (medicines used to help breathing). Your doctor may tell you to stop taking it 24 h ours before you are given Adenosine.
Caffeine (sometimes found in headache medicines).
Adenosine can interact with other medicines which inhibit conduction (e.g. beta blockers, digitalis, verapamil) or accelerate conduction (e.g. beta sympathomimetics).

Adenosine with food, drink and alcohol

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.

Pregnancy and breast-feeding

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.

You should not be given Adenosine if you are pregnant or think you may be pregnant, unless clearly necessary.

You should not be given Adenosine if you are breast-feeding.

Driving and using machines

Not known.

Adenosine contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. HOW YOU ARE GIVEN ADENOSINE

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

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 or nurse.

The ﬁrst dose is 3 mg 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 i s 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 d ose is 12 mg given as a rapid injection.
You should not have any more doses after the 12 mg dose.

The increasing dose scale above should be used until sufﬁcient diagnostic information is obtained.

Use in children and adolescents

Adenosine 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’s vein by a doctor or nurse.

If you are given more Adenosine than you should

As this medicine is given to you by a doctor or nurse it is unlikely that you will be given more than you require. Your doctor will carefully work out how much you should be given.

Adult

Paediatric population

Elderly

Pregnancy

Breast-feeding

The recommended dose is (adults and elderly):

Diagnostic dose:

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

Very low blood pressure (severe hypotension).
Slow heartbeat (bradycardia).
Stopping of heartbeat (asystole, cardiac arrest).

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 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.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

While you are being given Adenosine you may have some of the following 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.

If any of the following side effects get worse, tell your doctor or nurse and they may stop the injection.

Very common (may affect 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
usually transient and self-limiting heart problems (asystole)
shortness of breath or the urge to breathe deeply (dyspnoea)
chest pain or pressure on the chest

Common (may affect up to 1 in 10 people)

feeling dizzy or light-headed
feeling sick (nausea)
headache
unusual skin sensations such as burning
feeling nervous

Uncommon (may affect 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)
rise in the pressure inside the skull
feeling of general discomfort, weakness or pain
sweating

Very rare (may affect 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
very slow heart beat (severe bradycardia)

Not known (frequency cannot be estimated from the available data)

severe heart problems which can be fatal (asystole) or uneven heartbeat
fainting
ﬁts (convulsions)
being sick (vomiting)
stopping breathing (respiratory arrest)
hypotension sometimes severe
stroke/transient ischemic attack; secondary to the hemodynamic effects of adenosine, including hypotension
anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash)
myocardial infarction/elevation of ST segment, especially in patients with coronary artery disease - pre-existing s evere coronary artery disease
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 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.

Reporting of 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 Yellow Card Scheme Website: 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.

5. HOW TO STORE ADENOSINE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and ampoule after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Do not refrigerate.

The product is for single use only and should be used straight away after opening. Any portion of the ampoule not used at once should be disposed of.

Do not use this medicine if you notice any particles in the solution or any discolouration before they give you the medicine.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Method of administration

It should be administered by rapid IV bolus injection according to the ascending dosage schedule above. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline ﬂush. If administered through a peripheral vein, a large bore cannula should be used.

Adenosine should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.

Diagnostic dose

The above ascending dosage schedule should be employed until sufﬁcient diagnostic information has been obtained.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Adenosine contains

The active substance is adenosine.
The other ingredients are sodium chloride (see section 2) and water for injections.

Each 2 ml ampoule of Adenosine contains 6 mg of adenosine.

Each ml of solution for injection contains 3 mg of adenosine.

What Adenosine looks like and contents of the pack

Adenosine is a clear, colourless, sterile solution for injection, practically free from particles.

Each pack contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 A-B – Fervença 2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italia

This leaﬂet was last revised in June 2025

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Adenosine
Strength	6 mg / 2 ml (3 mg/ml)
Pharmaceutical form	Solution for injection Clear, colourless, sterile solution, practically free from particles. Solution as a pH between 4.5 – 7.5 and an Osmolality of 270 - 330 mOsm/Kg.
How is it taken	Intravenous
Excipients	Sodium chloride, Water for injections
Pack sizes	10 ampoule
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	2 years The ampoule content is intended for single dose administration. Any remaining portion of the ampoule content should be discarded immediately after initial use.
Storage	Do not store above 30°C. Do not refrigerate.
Drug group (ATC)	Other Cardiac Preparations C Cardiovascular system drugs C01 Cardiac therapy drugs C01E Other cardiac preparations C01EB Other plain cardiac preparations C01EB10 adenosine
Marketing authorisation	PL 15413/0095 (first authorised 23 September 2021)
Marketing authorisation holder	Hikma Farmacêutica (Portugal), S.A.
Codes	GTIN 5061024110255 · BNF 02030200

Adenosine 6 mg / 2 ml solution for injection – patient leaflet, side effects, dosage