Label: information for the user

Adrenalina B. Braun 1 mg/ml injectable solution

Epinephrine

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Adrenalina B. Braun and how is it used

2. What you need to know before starting to use Adrenalina B. Braun

3. How to use Adrenalina B. Braun

4. Possible adverse effects

5. Storage of Adrenalina B. Braun

6. Contents of the package and additional information

Adrenalina B. Braun belongs to the group of medications known as cardiac stimulants, excluding cardiac glycosides: adrenergic and dopaminergic agents.

It is indicated in 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 should be applied first).

No use Adrenalina B. Braun:

- If you are allergic to epinephrine (adrenaline), to sympathomimetics (medicines that stimulate the central nervous system) or to any of the other components of this medication (listed in section 6).

- If you have:

• Cardiac dilation, coronary insufficiency, cardiac arrhythmias or heart failure.
• Cerebral organic lesions, such as cerebral arteriosclerosis (chronic inflammation of the cerebral arteries with a tendency to obstruction).
• Angle-closure glaucoma (eye condition characterized by increased intraocular pressure).
• 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.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Adrenalina B. Braun.

Inform your doctor of any allergy or medical condition you have or have had, especially if you have or have had cerebral vascular insufficiency, heart disease (such as angina pectoris or myocardial infarction), chronic lung disease or urinary difficulty due to prostate hypertrophy.

This medication may 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.The injection sites should be alternated.

If you are diabetic, you should exercise special caution due to possible adverse reactions that may occur, especially those related to metabolic alterations, as the dose should be monitored.

Interference with diagnostic tests

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

Use in athletes

Inform athletes that this medication contains a component, epinephrine (adrenaline), which may establish a positive analytical result for doping control. However, the use of epinephrine (adrenaline) is permitted when administered associated with local anesthetics, or in local preparations, such as nasal or ophthalmic use.

Use ofAdrenalina B. Braun withother medications

Inform your doctor or pharmacist if you are taking, have taken recentlyor may have to take anyother 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 concurrently with digitalis glycosides (heart medications), cardiac arrhythmias may appear.

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

If this medication is administered concurrently 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 B. Braun may reduce the efficacy of hypoglycemic agents (medicines that decrease blood sugar).

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 respiration), or theophylline (antihistamine, facilitator of urination), your potassium levels in the blood should be monitored.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this 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, therefore, breastfeeding should be suspended or the administration of this medication should be avoided.

Adrenalina B. Braun contains sodium and sodium metabisulfite

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it containssodium metabisulfite.

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

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

Acute asthma attacks, allergic reactions, and anaphylactic shock.

Use in adults: The usual dose for the treatment of acute 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. In case of anaphylactic shock, the intramuscular or, in very severe cases, intravenous route should be used. If necessary, the administration can be repeated at 15-20 minutes and then every 4 hours. In severe cases, the dose can be increased up to 1 mg if necessary.

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

Use in children: The usual dose is 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.

Cardiac arrest and cardiopulmonary resuscitation

Use in adults: 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.

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

Adrenalina B. Braun will be administered by qualified healthcare personnel.

Adrenalina B. Braun can be administered via subcutaneous, intramuscular, intracardiac, or intravenous routes.

Only in cases of extreme gravity and if the intravenous route is not feasible, it can be administered via intracardiac. The intravenous and intracardiac routes can only be used after dilution in injectable preparations, sodium chloride 0.9% solution, 5% glucose solution, or 5% glucose solution in sodium chloride 0.9%, in a hospital setting and under cardiac monitoring.

If 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 when the intravenous route is persistently inaccessible.

The intramuscular injection of this medication should be avoided in the buttocks, as it may lead to gas gangrene (diffuse, rapid tissue necrosis under the skin with gas production) and in peripheral areas of the body, such as fingers, toes, earlobe, nose, or penis.

If you use more Adrenalina B. Braun than you should:

Adrenaline overdose can cause sudden increases in blood pressure and tachycardia, which may occur after a transient phase of bradycardia. Potentially fatal arrhythmias may also appear.

The duration of the adverse effects of adrenaline is brief due to its rapid inactivation in the body, so supportive treatment is used to correct the adverse effects on blood pressure and heart rate. Medications such as fentolamine and propranolol can be administered to correct the adverse effects on blood pressure and heart rate.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

It is worth noting 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 to <1)

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

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

These manifestations are not serious and disappear with rest and patient calm.

- Infrequent (> 1/1000 to <1)

Cardiovascular disorders (heart and blood vessels): hypertension, which could lead to cerebral hemorrhage or acute heart failure with pulmonary edema (fluid infiltration in the lungs), angina pectoris (even with common doses in patients with coronary insufficiency), ventricular arrhythmias (alteration of heartbeats), 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.

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

No special storage conditions are required. Store in the original packaging to protect it from light.

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.

The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Do not use if you see that the solution has discoloration or sedimentation.

Composition of Adrenalina B. Braun

The active ingredient of Adrenalina B. Braun is epinephrine (adrenaline).

Each ml of the medication contains 1 mg of epinephrine (adrenaline).

The other components are sodium chloride, sodium metabisulphite (E-223), hydrochloric acid (for pH adjustment) and water for injection preparations.

Appearance of the product and contents of the packaging

Adrenalina B. Braun is a transparent and slightly yellowish aqueous solution that is presented in 1 ml glass ampoules. Packaging sizes:

Boxes of 10 and 100 units.

Marketing Authorization Holder:

Name: B. BRAUN MEDICAL, S.A.

Address: Ctra. de Terrassa, 121.

Rubí(Barcelona) - 08191- Spain

Responsible for manufacturing:

Name: B. BRAUN MEDICAL, S.A.

Address: Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

Jaén (Jaén) – 23009 - Spain

Last review date of this leaflet: November 2019

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/)

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals:

Treatment of overdose

To correct the adverse effects on blood pressure and heart rhythm, some medications such as fentolamine and propranolol may be administered.

If a sudden increase in blood pressure occurs, vasodilator medications, such as nitrites, may be administered. Angina attacks are treated with sublingual trinitrate, while in cases of ventricular fibrillation (abnormal heart contraction), an electric defibrillator should be used.