Isoprenaline Hydrochloride 1 mg/5 ml concentrate for 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.

The name of your product is Isoprenaline Hydrochloride 1 mg/5 ml concentrate for solution for infusion but it will be referred to as Isoprenaline throughout this leaflet.

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

• if you are allergic to isoprenaline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are also taking adrenaline, a medicine used in intensive care to treat cardiac arrest (when the heart suddenly stops beating).
• if you suffer from a faster-than-usual heart rhythm.
• if your heart is stressed (atrial or ventricular hyperexcitability).
• if you have taken too much of a type of medicine called cardiac glycoside, such as digoxin (digitalis), a medicine to treat heart arrythmia and heart failure.
• if you suffer from a heart attack (myocardial infarction).
• if you suffer from chest pain (angina pectoris) and irregular heartbeat (ventricular arrhythmia) that requires treatment.

Talk to your doctor or nurse before you are given Isoprenaline:

• if you have heart problems.
• if you suffer from diabetes.
• if you are taking digoxin (digitalis) (another medicine affecting the heart).
• if you have an overactive thyroid gland. This medicine is to be avoided in cases of uncontrolled hyperthyroidism.
• if you suffer from convulsive disorders (epilepsy).
• if you have ever had a reaction to a medicine affecting the heart and circulation (belonging to the sympathomimetic amine group).
• during your treatment with this medicine, you will be monitored by ECG and your dose may be adjusted.
• if you are being treated for decreased blood volume in the body (shock), Isoprenaline can only be used after your blood volume has been restored.
• be particularly careful in cases of doses high enough to reach a heart rate of above 130 beats/minute.

Tell your doctor if you are using, have recently used or might use any other medicines.

This is particularly important if you are taking any of the following medicines:

• other cardiac or central nervous system stimulants (medicines for heart or brain).
• adrenaline (a medicine used in intensive care to treat cardiac arrest).
• digitalis (another medicine affecting the heart).
• monoamine oxidase inhibitors (MAOIs), a class of medicines used to treat depression.
• antidepressants (such as imipramine).
• sulphates, such as salicylamide (painkiller).
• entacapone (a class of medicine used for Parkinson’s disease).
• doxapram (a class of medicine used in intensive care to increase respiratory rate).
• ergotamine (a class of medicines used to treat acute migraine attacks).
• sympathomimetic vasoconstrictors (such as oxytocin).

Isoprenaline may not be administered under chloroform, cyclopropane or halothane anaesthetics or any other halogen anaesthetic.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are pregnant, this medicine may only be used if the doctor considers it absolutely necessary.

The administration of Isoprenaline during the breast-feeding period is not recommended.

This medicine contains approx. 16.5 mg sodium (main component of cooking/table salt) in each 5 ml of sterile solution. This is equivalent to approx. 0.8 % of the recommended maximum daily dietary intake of sodium for an adult.

The symptoms of overdose are nausea, headaches, extra heart beats and heart rate acceleration.

If you think you were given more Isoprenaline than you should, contact your doctor or nurse immediately.

If necessary, a plasma or complete blood transfusion may be performed.

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 at 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.

• The active substance is isoprenaline hydrochloride.
  Each ampoule with 5 ml of Isoprenaline contains 1 mg isoprenaline hydrochloride, equivalent to 0.853 mg of isoprenaline.
• The other ingredients are disodium edetate (E386), sodium chloride, sodium citrate (E331), citric acid (E330), hydrochloric acid, concentrated (E507) (for pH adjustment), water for injection.

Isoprenaline Hydrochloride 1 mg/5 ml concentrate for solution for infusion is a clear, colourless solution, practically free from visible particles.

It is supplied in clear colourless type I glass ampoules with a white fracture crack, containing 5 ml.

Packages of 5 ampoules.