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

1. What Adenosine Solution for Infusion is and what it is used for
2. What you need to know before you are given Adenosine Solution for Infusion
3. How you will be given Adenosine Solution for Infusion
4. Possible side effects
5. How to store Adenosine Solution for Infusion
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 a disorder that affects the heart’s electrical activity (Long QT syndrome);
• if you have very low blood pressure (severe hypotension);
• if you have unstable angina (severe chest pain) that is not currently controlled by either treatment or medication;
• if you have a type of heart failure where your heart does not pump out enough blood;
• if you have asthma or any other severe breathing problems;
• if you are taking a medicine called dipyridamole, used to thin the blood;
• if you are below 18 years of age. The use of Adenosine Solution for Infusion in children and adolescents has not been sufficiently studied.

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 Infusion will increase the effect of adenosine on the body. Your doctor or nurse may decide not to give you Adenosine Solution for Infusion, may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Solution for Infusion, 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 Infusion.
• 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 Infusion.

• 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 dose is based on your body weight.
• Your doctor or nurse will decide how much to give you.
• The usual dose is 140 micrograms per kilogram, per minute, given over a period of six minutes.

The safety of Adenosine Solution for Infusion in children is not known. Therefore, it is not recommended for use in children. If the doctor or nurse decides that this medicine is needed, they will determine the most appropriate dose to give.

As this medicine is 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 time. Therefore, any side effects would soon subside once the infusion has been stopped. You may be given a medicine called aminophylline or theophylline to help with any side effects experienced. If you have any further questions on the use of this medicine, ask your doctor or nurse.

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 10ml vial contains 30mg adenosine (3mg per ml).
• The other ingredients are sodium chloride and water for injections.

Adenosine Solution for Infusion (Adenosine Infusion) is a clear, colourless solution in a clear, glass vial. Each vial contains 10ml of medicine. This product is available in cartons containing 6 x 10ml 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 30mg/10ml Solution for Infusion

Ireland: Adcus™ 3mg/ml Solution for Infusion

Greece: ADENORYTHM^® 3mg/ml Διάλυμα για έγχυση