ADRENALINE B. BRAUN 1 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Adrenaline B. Braun 1 mg/ml Solution for Injection

Epinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Adrenaline B. Braun is and what it is used for
2. What you need to know before you use Adrenaline B. Braun
3. How to use Adrenaline B. Braun
4. Possible side effects
5. Storage of Adrenaline B. Braun
6. Contents of the pack and other information

1. What Adrenaline B. Braun is and what it is used for

Adrenaline B. Braun belongs to a group of medicines called cardiac stimulants, excluding cardiac glycosides: adrenergic and dopaminergic agents.

It is indicated in the following cases:

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

2. What you need to know before you use Adrenaline B. Braun

Do not use Adrenaline B. Braun:

• If you are allergic to epinephrine (adrenaline), sympathomimetics (medicines that stimulate the central nervous system) or any of the other components of this medicine (listed in section 6).
• If you suffer from:
  • Cardiac dilation, coronary insufficiency, cardiac arrhythmias or cardiac insufficiency (heart failure).
  • Organic brain damage, such as cerebral arteriosclerosis (chronic inflammation of the brain arteries with a tendency to obstruction).
  • Angle-closure glaucoma (eye condition characterized by increased intraocular pressure).
  • Hypertension, hyperthyroidism (thyroid gland disorder) or pheochromocytoma (tumor of the adrenal medulla).
  • During childbirth.

• If you have received general anesthesia with halogenated hydrocarbons (chloroform, trichloroethylene) or cyclopropane, as the combination with adrenaline may cause severe arrhythmias (alteration of heartbeats).

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

Warnings and precautions

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

Inform your doctor of any allergy or medical problem you have or have had, especially if you suffer from or have suffered from cerebrovascular insufficiency (condition of the blood vessels in the brain), heart disease (such as angina pectoris or myocardial infarction), chronic pulmonary disease or urinary difficulty due to prostatic hypertrophy (prostate disorder).

This medicine 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 points should be alternated.

If you are diabetic, you should be especially cautious due to possible adverse reactions that may appear, especially those related to metabolic disorders, as the dose should be monitored.

Interference with diagnostic tests

If you are going to have any diagnostic tests (blood or urine tests), inform your doctor that you are being treated with adrenaline, as this medicine may alter the results of blood sugar, bilirubin, cholesterol, lactates, uric acid, and insulin. In urine, adrenaline may alter the results of vanilmandelic acid and catecholamines.

Use in athletes

Athletes are informed that this medicine contains a component, epinephrine (adrenaline), which may result in a positive doping test. However, the use of epinephrine (adrenaline) is allowed when administered in combination with local anesthetics or in preparations for local use, such as nasal or ophthalmological use.

Use of Adrenaline B. Braun with other medicines

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

Adrenergic blockers (drugs that act on 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 poisoning.

If this medicine is administered in combination with digitalis glycosides (heart medicines), cardiac arrhythmias (alteration of heartbeats) may appear.

If this medicine is administered in combination with certain antidepressants or guanidine (antihypertensive agent), a sharp increase in blood pressure may occur.

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

Adrenaline B. Braun may reduce the effectiveness of hypoglycemic agents (medicines that decrease blood sugar).

If you are taking any other medicine that may cause potassium loss, such as corticosteroids (medicines used for their anti-inflammatory and immunosuppressive properties), diuretics (which facilitate urination), aminophylline (medicine used to facilitate breathing), or theophylline (anti-asthmatic, facilitating urination), your potassium levels in the blood should be monitored.

Pregnancy and lactation

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

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

This medicine is excreted in breast milk; therefore, breastfeeding should be suspended or the administration of this medicine avoided.

Adrenaline B. Braun contains sodium and sodium metabisulfite

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

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

3. How to use Adrenaline B. Braun

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

The smallest 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.

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) by intramuscular or subcutaneous route, with the intramuscular route being faster and more effective. In case of anaphylactic shock, the intramuscular route should be used, or in very severe cases, the intravenous route. If necessary, administration can be repeated at 15-20 minute intervals and subsequently 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 with special caution.

Use in children: The usual dose is 0.01 mg (0.01 ml) per kg of body weight by intramuscular or subcutaneous route, up to a maximum dose of 0.5 mg (0.5 ml). If necessary, administration can be repeated at 15-20 minute intervals and subsequently 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 by intravenous route, 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 by intravenous route, which can be repeated every 5 minutes if necessary.

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

Adrenaline B. Braun can be administered by subcutaneous, intramuscular, intracardiac, or intravenous route.

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

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

Injection of this medicine into the muscles of the buttocks should be avoided, as it may cause gas gangrene (diffuse, rapid tissue gangrene 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 Adrenaline B. Braun than you should:

Overdose of adrenaline can cause sudden increases in blood pressure and tachycardia (acceleration of heart rate), which may occur after a first phase of transient bradycardia (abnormal slowness of heart rate). Potentially fatal arrhythmias (alteration of heartbeats) 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 adverse effects on blood pressure and heart rate, some medications such as phentolamine and propranolol can be administered.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It should be noted that the appearance and severity of these effects depend on the route of administration, with the subcutaneous and intramuscular routes being those with the lowest incidence compared to the intravenous and intracardiac routes.

• Frequent (1/100 to <1>

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

Cardiovascular disorders: tachycardia, palpitations, pallor, elevated (discrete) blood pressure.

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

• Uncommon (> 1/1000 to <1>

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

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

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Adrenaline B. Braun

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

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

Do not use this medicine after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Adrenaline B. Braun

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

Each ml of medicine contains 1 mg of epinephrine (adrenaline).

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

Appearance of the product and contents of the pack

Adrenaline B. Braun is a clear, slightly yellowish aqueous solution presented in 1 ml glass ampoules. Package 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

Manufacturer:

Name: B. BRAUN MEDICAL, S.A.

Address: Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

Jaén (Jaén) – 23009 - Spain

Date of the last revision of this leaflet: November 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS). (http://www.aemps.gob.es/)

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This information is intended only for doctors or healthcare professionals:

Treatment of overdose

To correct the adverse effects on blood pressure and heart rate, some medications such as phentolamine and propranolol can be administered.

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