Adenosine 3mg/ml Solution for Injection (Focus)

• 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 side effects not listed in this leaflet. See section 4.

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

• if you are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6);
  • if you have an irregular heart rhythm and do not currently have a pacemaker fitted;
• if you have asthma or any other severe breathing problems;
• if you have a disorder that affects the heart’s electrical activity (Long QT syndrome);
  • if you have very low blood pressure (severe hypotension);

if you have a type of heart failure where your heart does not pump out enough blood;

if you are below 18 years of age. In children with a heart rhythm problem called ‘Wolff- Parkinson-White (WPW) syndrome’, Adenosine Solution for Injection may cause some unexpected severely abnormal heart rhythm.

Tell your doctor or nurse if any of the following apply to you:

• if you have recently had a heart attack, heart failure, or you have had a heart transplant within the last year;
• if you have a low blood volume level that has not been corrected by either treatment or medication;
• if you have a type of heart disease caused by the narrowing of your heart valves;
• if your heart is inflamed, enlarged, or you have fluid around your heart;
• if you have seizures or convulsions (fits);
• if you have difficulty breathing;
• if you suffer from problems with your autonomic nervous system;
• if you suffer from a narrowing of the main arteries in your neck (carotid arteries) that prevents sufficient blood getting to your brain;
• if you have a known heart defect;
• if you have an unusual heart rhythm (atrial fibrillation or flutter).

Make sure your doctor or nurse knows if you are taking, or have recently taken, any of the medicines listed here:

• Dipyridamole (used to thin the blood); taking dipyridamole at the same time as Adenosine Solution for Injection will increase the effect of adenosine on the body. Your doctor or nurse may decide not to give you Adenosine Solution for Injection, may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Solution for Injection, or they may lower the dose.
• Aminophylline and theophylline (used to help breathing difficulties), or medicines containing Xanthines (caffeine), which are found in certain medicines used to treat headaches. Your doctor may tell you to stop taking these medicines 24 hours before you are given Adenosine Solution for Injection.
• Medicines that affect the rate at which your heart conducts electrical impulses such as calcium channel blockers e.g. diltiazem and amlodipine, beta-adrenergic blocking agents e.g. propranolol and metoprolol and centrally acting agents e.g. clonidine and guanfacine.

Please also tell your doctor or nurse if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

• Where possible, do not drink or eat products containing caffeine, such as tea, coffee, chocolate, or cola, for at least 12 hours before you are given Adenosine Solution for Injection.

• 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 they give you this medicine.
• You should not be given this medicine if you are breast-feeding.

Your medicine contains sodium (salt). This medicinal product contains 3.54mg (0.15mmol) of sodium (salt) per 1ml of solution. To be taken into consideration by patients on a controlled sodium (salt) diet.

• The usual dose is 3mg (1ml) given over 2 seconds.
• If the first dose does not bring your heartbeat back to normal within 1-2 minutes, you will be given a second dose of 6mg (2ml).
• If the second dose does not bring your heartbeat back to normal within 1-2 minutes, you will be given a third dose of 12mg (4ml).
• You should not be given any more doses after the 12mg (4ml) dose.

Adenosine Solution for Injection 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 the 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.

As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are given too much medicine, the following side effects may occur:

• an extreme lowering in blood pressure;
• a lowering in heart rate;
• a heart problem.

Adenosine stays in the blood for a very short period of timxe. Therefore, any side effects would soon subside once the injection has been stopped. You may be given a medicine called aminophylline or theophylline to help with any side effects experienced.

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 side effects directly via the Yellow Card Scheme at: . By reporting side effects you can help provide more information on the safety of this medicine.

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

Adenosine Solution for Injection (Adenosine Injection) is a clear, colourless solution in a clear, glass vial. Each vial contains 2ml of medicine. This product is available in cartons containing 6 x 2ml vials.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Adenosine 3mg/ml Solution for Injection

Ireland: Adenosine 3mg/ml Solution for Injection

Greece: ADENORYTHM^® 3mg/ml Ενέσιμο διάλυμα