Leaflet: information for the user

Isoprenaline Sulfate 0.2 mg/ml injectable solution

Isoprenalina Sulfato

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse even if they are not listed in this leaflet.

1. What is Isoprenaline Sulfate 0.2 mg/ml injectable solution and what it is used for

2. What you need to know before starting to take Isoprenaline Sulfate 0.2 mg/ml injectable solution

3. How to take Isoprenaline Sulfate 0.2 mg/ml injectable solution

4. Possible side effects

5. Storage of Isoprenaline Sulfate 0.2 mg/ml injectable solution

6. Contents of the pack and additional information

Aleudrina belongs to a group of medications known as beta-adrenergic agonists, which stimulate the frequency and force of heart contraction.

Aleudrina is used in the treatment of Morgagni-Stokes-Adams Syndrome (transient appearance of dizziness, loss of consciousness, and seizures due to sudden reduction in cerebral blood flow), bradycardia (decrease in heart rate), and cardiac blocks. It is also used in situations involving insufficient cardiac output, such as cardiogenic shock (the heart is unable to pump the necessary blood) or after cardiac surgery.

No use Aleudrina 0.2 mg/ml

• If you are allergic (hypersensitive) to isoprenaline or to any of the other components of this medication (listed in section 6).
• If you have hyperthyroidism (a metabolic disorder in which there is an excess of thyroid gland function).
• If you have had or have angina pectoris.
• If you suffer from tachyarrhythmias with increased heart rate.
• If you have decompensated heart disease (heart failure).
• If you have aortic stenosis (the aortic valve is narrowed).
• If you have had a recent myocardial infarction
• If you have tachycardia (increased heart rate), or cardiac block (the cardiac stimulus does not propagate correctly) as a result of the use of digitalis (medication for the treatment of heart failure and alterations of the heart rhythm that are obtained from digital).
• If you take other beta-1 agonists such as adrenaline, due to the risk of arrhythmias (see sectionInteraction of Aleudrina 0.2mg/ml with other medications).

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Aleudrina:

• If you are elderly
• If you are diabetic
• If you have hyperthyroidism
• If you have hypersensitivity to pharmacological stimulants, e.g. adrenaline
• If you have cardiovascular diseases such as: ischemic heart disease (not enough blood and oxygen reaches the heart), arrhythmia (disorder of the heart rhythm), or tachycardia, vascular occlusive disease (arteries narrow) including arteriosclerosis (hardening of the walls of the arteries).
• If you are being treated with digitalis
• If you are hypertensive
• If you have aneurysms (widening of the walls of the arteries)
• If you have prostate problems
• If you have narrow-angle glaucoma (disorder with increased intraocular pressure)
• If you are pregnant and the birth is near, as it inhibits uterine contractions
• If you are breastfeeding
• If you have liver disease
• If you have kidney disease
• If you have asthma
• If you have epileptic seizures.

Use with caution when administered simultaneously with monoamine oxidase inhibitors (MAOIs) (type of antidepressant medication) (see sectionUse of other medications).

If there is an increase in cardiac excitability (heart rhythm disorders) and a tendency to extrasystoles (rapid contraction of the ventricles of the heart), your doctor will prescribe a particularly cautious dosage.

Use in athletes:

Inform athletes that this medication contains isoprenaline, which may result in a positive test in doping control tests.

Interaction of Aleudrina 0.2mg/ml with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Aleudrina should not be administered simultaneously with sympathetic agonists such as adrenaline, other sympathetic amines, or tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), as their combined effect may induce arrhythmias.

Isoprenaline increases the elimination of theophylline (bronchodilator) and may potentiate hypokalemia (low potassium level), hyperglycemia (high blood sugar), tachycardia, and hypertension.

Beta-adrenergic blockers (medication that helps to lower the heart rate) such as propranolol may antagonize the effect of isoprenaline.

Aleudrina should be used with caution in patients who are administered halogenated anesthetics or cyclopropane (types of anesthetic gases), as arrhythmias may occur.

Fertility, pregnancy, lactation

No effect on fertility is known.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Due to the inhibitory effect on uterine contractions, it should be used with caution in the periods near childbirth.

The excretion of isoprenaline in breast milk is unknown, so the benefits of treatment must be weighed against the potential risk before administering this medication.

Driving and operating machinery

No, as Aleudrina is only intended for use in emergency situations.

Important information about some of the components of Aleudrina 0.2mg/ml

This medication may produce severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulphite (E 223).

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, so it is considered essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

For intravenous infusion, one vial (0.2 mg or 200 gammas of isoprenaline sulfate) is diluted in 100 ml of infusion liquid and administered at a rate of 20 drops (= 1 ml) per minute, 2 gammas of Aleudrina (equivalent to 0.002 mg of Aleudrina) are administered..

This is the dose administered when for the infusion of 1 vial, an approximate time of 1 1/2 hours is calculated.

Children:

Children are administered 1/4 to 1/2 of the adult dose.

In special situations (Stokes-Adams, shock (the heart is unable to pump the necessary blood) or collapse (sudden and severe drop in blood pressure causing respiratory failure)), where intravenous infusion cannot be performed, 1/2 to 1 vial of Aleudrina may be injected subcutaneously or more rarely intramuscularly.

In case of insufficient response, the possibility of a metabolic acidosis situation (pathology due to excess acid in tissues and blood) may be considered.

In this case, the administration of lactate or sodium bicarbonate infusions or other buffer solutions is recommended until the alkaline reserve is balanced.

If you use more Aleudrina 0.2mg/ml than you should

In exceptional cases of administration of really excessive doses, some of the following symptoms, characteristic of beta-adrenergic stimulant poisoning, may appear: facial flushing, hand tremors, restlessness, palpitations, extrasystoles (premature heartbeat), ventricular fibrillation (chaotic increase in heart rate), cardialgias (heart pain), nausea.

Deep hypotension (severe drop in blood pressure) may occur and symptoms similar to shock may develop.

Treatment:

Most toxic effects will subside upon discontinuation of treatment.

Medications blocking beta-adrenergic receptors will be used. In addition, sedatives or tranquilizers will be administered.

In case of overdose or accidental injection, consult your doctor, pharmacist, or nurse or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount injected.

Like all medications, Aleudrina can produce adverse effects, although not all people may experience them.

The main adverse reactions include tachycardia, arrhythmias, palpitations, hypotension, tremors, headache, sweating, and hot flashes. Prolonged use has been associated with parotid gland edema.

Other adverse reactions that may occur include anxiety, fear, restlessness, insomnia, confusion, irritability, headache, and psychotic states. Dyspnea, weakness, anorexia, nausea, and vomiting are also common.

In a paradoxical manner, isoprenaline has precipitated Stock-Adams attacks (Transient cardiac arrest) in some patients during normal sinus rhythm or transient atrioventricular block.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Store in refrigerator (between 2°C and 8°C)

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

Do not use Aleudrina after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aleudrina 0.2mg/ml

- The active ingredient is Isoprenaline sulfate.

- The other components (excipients) are:

Sodium metabisulphite (E 223), disodium edetate, sodium chloride, hydrochloric acid, and water for injection preparations.

Appearance of the product and content of the packaging

Clear, colorless solution.

Each 1 ml ampoule contains 0.2 mg of isoprenaline sulfate.

Holder of the marketing authorization and responsible for manufacturing

Reig Jofré Laboratory

c/ Gran Capitán 10

08970 Sant Joan Despí

Barcelona

This leaflet was approved in January 2012

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/