PATIENT INFORMATION LEAFLET

Adrenalina Level 1 mg/ml injectable solution

Epinephrine

Read this leaflet carefully before you start using 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 as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Adrenalina Level is and for what it is used

2. What you need to know before starting to use Adrenalina Level

3. How to use Adrenalina Level

4. Possible side effects

5. Storage of Adrenalina Level

6. Contents of the pack and additional information

Adrenalina Level belongs to the group of medications known as cardiac stimulants, excluding cardiac glycosides: adrenergic and dopaminergic agents. It is indicated for the following cases:

• Treatment of sudden and involuntary contraction of the airways in acute asthma attacks (sudden feeling of choking).
• Rapid relief of allergic reactions to medications or other substances.
• Emergency treatment of shock due to an allergic reaction.
• Cardiac arrest and cardiopulmonary resuscitation (physical measures must be applied first).

No use Adrenalina Level

• If you are allergic (hypersensitive) to adrenaline, sympathomimetics (medicines that stimulate the central nervous system) or any of the other components of this medication (listed in section 6).
• If you have heart dilation, coronary insufficiency, cardiac arrhythmias or heart failure (heart function failure).
• If you have organic brain injuries, such as cerebral arteriosclerosis (chronic inflammation of the brain arteries with a tendency to obstruction).
• If you have closed-angle glaucoma (eye condition characterized by increased intraocular pressure).
• If you have high blood pressure, hyperthyroidism (thyroid gland alteration) or pheochromocytoma (adrenal gland tumor).
• During childbirth.
• If you have received general anesthesia with halogenated hydrocarbons (chloroform, trichloroethylene) or cyclopropane, as the combination with adrenaline could cause severe arrhythmias (heart rhythm alteration).

However, in extreme situations, there are no absolute contraindications.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Adrenalina Level.

Be especially careful with Adrenalina Level

If you have or have had cerebrovascular insufficiency (vascular disease of the brain), heart disease (such as angina pectoris or myocardial infarction), chronic lung disease or urinary difficulties due to prostate hypertrophy (prostate alteration).

If you are taking any other medication that may cause potassium loss, such as corticosteroids (medicines used for their anti-inflammatory and immunosuppressive properties), diuretics (facilitate urination), aminophylline (medication used to facilitate breathing) or theophylline (antihistamine, facilitator of urination), your doctor should monitor your potassium levels in the blood.

If you are diabetic, you should be especially cautious of possible adverse reactions that may occur, especially related to metabolic alterations, as your dose should be monitored.

This medication can be used in elderly patients, but special caution is recommended.

Repeated administration of local injections may cause necrosis at the injection site due to vascular vasoconstriction (contraction of blood vessels). Injection sites should be alternated.

Adrenaline should be diluted before its injection for intravenous and intracardiac use (see section 3). In cases of extreme urgency, such as cardiopulmonary resuscitation (CPR) and cardiac arrest, where it is not possible to dilute the medication and it is considered necessary to administer it intravenously without dilution, directly through a catheter, it is necessary to know the compatibility of the pre-loaded syringe with the antiretrograde valve to avoid administration problems due to possible blockages of the syringe with components of the antiretrograde valve lodged in the catheter. In case of incompatibility, use an appropriate adapter between the syringe and the antiretrograde valve. Cases have been reported in which the medication could not be administered due to these incompatibility problems, with the consequent risk to the patient.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Other Medications and Adrenalina Level

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Adrenergic blockers (medicines that act at the level of neurons and modify the physiology of organs and tissues) antagonize some of the effects of adrenaline. They are used as therapy in the case of adrenaline intoxication.

If this medication is administered together with digitalis glycosides (heart medications), cardiac arrhythmias (heart rhythm alteration) may appear.

If this medication is administered together with certain antidepressants or guanidine (anti-hypertensive agent), a severe increase in blood pressure may occur.

If this medication is administered together with COMT or MAO inhibitors (medicines that act on the metabolic systems responsible for eliminating adrenaline), the effects of this medication may be potentiated to a lesser extent.

Adrenalina Level may reduce the effectiveness of hypoglycemic agents (medicines that decrease blood sugar).

Interference with Analytical Tests

If you are to undergo any analytical test (blood or urine analysis), inform your doctor that you are being treated with adrenaline, as this medication may alter the results in the blood of sugar, bilirubin, cholesterol, lactates, uric acid, and insulin. In urine, adrenaline may alter the results of vanillylmandelic acid and catecholamines.

Pregnancy and Lactation

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

Consult your doctor or pharmacist before using any medication.

If you are pregnant, you will only receive adrenaline if your doctor considers it absolutely necessary for your treatment.

This medication is excreted in breast milk, so it is recommended to suspend breastfeeding or avoid administering this medication.

Driving and Operating Machines

This is not applicable in the context of treatment with this medication.

Adrenalina Level contains sodium bisulfite (E-222) and sodium (in the form of sodium bisulfite and sodium chloride).

This medication contains less than 1 mmol of sodium (23 mg) per 1 ml, which is essentially "sodium-free".

Use in Athletes

This medication contains adrenaline, which may produce a positive result in doping control tests.

The use of adrenaline is not prohibited when it is administered in association with local anesthetics, or in local preparations, such as nasal or ophthalmic use.

Adrenalina Level will be administered by qualified medical personnel in the event of intravenous or intracardiac administration.

Adrenalina Level can be administered subcutaneously, intramuscularly, or intravenously. Only in cases of extreme gravity and if intravenous administration is not feasible, it can be administered intracardiacally. Intravenous and intracardiac routes can only be used after dilution in water for injection, sodium chloride 0.9% solution, glucose 5% solution, or glucose 5% in sodium chloride 0.9% solution, always in a hospital setting and under cardiac monitoring.

In cases of extreme urgency, such as cardiopulmonary resuscitation (CPR) and cardiac arrest where the medication cannot be diluted and it is considered essential to administer intravenously directly from the preloaded syringe without dilution, through a catheter, it is necessary to know the compatibility of the preloaded syringe with the antireturn valve to avoid administration problems due to possible blockages of the syringe with components of the antireturn valve lodged in the catheter. In case of incompatibility, use an appropriate adapter between the syringe and the antireturn valve. Cases have been reported where the medication could not be administered due to these incompatibility problems, with the consequent risk to the patient.

The lowest dose that produces relief should be used. After prolonged use, it may be necessary to increase the doses due to the development of resistance to the action of adrenaline.

This medication should not be injected intramuscularly in the buttocks, as it may cause gas gangrene (diffuse, rapid tissue necrosis under the skin with gas production) and in peripheral areas of the body, such as fingers, hands, feet, earlobe, nose, or penis.

Acute asthma attacks, allergic reactions, and anaphylactic shock

- Adults:The usual dose for the treatment ofacute asthma attacks and allergic reactions is 0.3-0.5 mg (0.3-0.5 ml) via intramuscular or subcutaneous injection, with intramuscular being the faster and more effective route.If necessary, the administration can be repeated at 15-20 minutes and then every 4 hours. In cases of anaphylactic shock, the intramuscular or, in very severe cases, intravenous route should be used, if the intravenous route is used, adrenaline should be administered in a hospital. In severe cases, the dose can be increased to 1 mg if necessary.

- Children:The usual doseis 0.01 mg (0.01 ml) per kilogram of body weight via intramuscular or subcutaneous injection up to a maximum dose of 0.5 mg (0.5 ml).If necessary, the administration can be repeated at 15-20 minutes and then every 4 hours.

This medication cannot be administered to children weighing less than 20 kg, as the minimum volume that allows dosing the syringe is 0.2 ml.

In elderly patients, the indicated doses are the same as for adults, although special caution should be exercised.

Cardiac arrest and cardiopulmonary resuscitation

In the treatment of cardiac arrest and cardiopulmonary resuscitation, the recommended dose of adrenaline is 1 mg via intravenous injection, which should be administered after dilution to 1:10,000 and can be repeated as many times as necessary every 3-5 minutes.

In children, the standard dose is 0.01 mg/kg via intravenous injection, which can be repeated every 5 minutes if necessary.

This medication cannot be administered to children weighing less than 20 kg, as the minimum volume that allows dosing the syringe is 0.2 ml.

In the event that the intravenous route is not feasible, the intracardiac route (using the same diluted solution) can be used. However, it should be noted that this route presents significant risks and should only be used in cases where the intravenous route is persistently inaccessible.

Guidelines for correct administration

Remove the removable part of the protective cap (1) located in the cone of the syringe and replace it with the needle (2). Expel the air and the syringe will be ready for use.

This syringe should be used once and destroyed. Shared use constitutes a risk of infection.

To avoid degradation by light or oxidation, it is recommended to use the product immediately after dilution.

If you use more Adrenalina Level than you should

Adrenaline overdose can cause sudden increases in blood pressure and tachycardia (rapid heart rate), which may occur after a transient phase of bradycardia (abnormal slowing of the heart rate). Arrhythmias (potentially fatal alterations of the heart rhythm) may also appear.

The duration of the adverse effects of adrenaline is brief due to its rapid inactivation in the body, so the treatment of adverse reactions is supportive. To correct the effects of adrenaline on blood pressure and heart rate, some medications such as fentolamine and propranolol can be administered. If a sudden increase in blood pressure occurs, vasodilator medications such as nitrates can be administered. Angina attacks are treated with sublingual trinitrate, while in cases of ventricular fibrillation (abnormal contraction of the heart), a defibrillator should be used.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

It is essential to note that the appearance and severity of these effects depend on the route of administration, with subcutaneous and intramuscular routes having a lower incidence compared to intravenous and intracardiac routes.

-Frequent(>1/100, <1>

Nervous system disorders: fear, anxiety, pulsating headache, respiratory difficulty, sweating, and nausea, vomiting, tremors, and dizziness.

Cardiovascular disorders: tachycardia, palpitations, pallor, and a slight increase in blood pressure.

These manifestations are not severe and disappear with rest and patient calmness.

-Rare(>1/1000, <1>

Cardiovascular disorders (heart and blood vessels): hypertension, which could lead to cerebral hemorrhage or acute heart failure with pulmonary edema (lung infiltration with fluid), angina pectoris (even with common doses in patients with coronary insufficiency), ventricular arrhythmias (heart rhythm alteration), tachycardia (acceleration of rhythm), and ventricular fibrillation (abnormal heart contraction), which can be fatal.

Difficulty urinating, necrosis at the injection site, metabolic acidosis, and renal failure have also been observed in some cases.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

No special storage conditions are required. Store in the original packaging.

Adrenaline Level must be used immediately after opening the syringe. Discard any remaining portion.

Do not use Adrenaline Level if you observe that the solution has discoloration or sedimentation.

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Adrenalina Level

• The active principle is epinephrine (adrenaline). Each milliliter of solution contains 1 milligram of epinephrine.
• The other components are sodium chloride, sodium bisulfite (E-222), chlorobutanol, hydrochloric acid (for pH adjustment) and injection water.

Appearance of the product and contents of the packaging

Adrenalina Level is a transparent, slightly yellowish aqueous solution that is presented in preloaded glass syringes of Type I with a capacity of 1 milliliter.

Packaging sizes: Boxes of 1 or 50 units.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Responsible manufacturer:

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain.

Last review date of this leaflet: July 2022

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