Leaflet: Information for the User

Adrenalina Ethypharm 1 mg/ml injectable solution

Epinephrine

Read this leaflet carefully before you start using the medicine, because 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 nurse.
• This medicine has been prescribed only for you, and you must not give it 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 Ethypharm is and for what it is used

2. What you need to know before receiving Adrenalina Ethypharm

3. How to use Adrenalina Ethypharm

4. Possible side effects

5. Storage of Adrenalina Ethypharm

6. Contents of the pack and additional information

Epinephrine belongs to a group of medicines known as sympathomimetic agents.

Epinephrine injection may be used for emergency treatment of severe allergic reactions or cardiac arrest.

No use Adrenalina Ethypharm if:

•is allergic (hypersensitive) to adrenaline or any of the components of this medication (listed in section 6).

•Adrenaline injections should not be applied in areas such as the fingers of the hands or feet, the ears, the nose, the genitals, or the buttocks, as it could affect blood flow to these areas.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Adrenalina Ethypharm if:

• is elderly
• has any heart problems, especially if it affects heart rate or suffers from chest pain
• has brain problems, such as stroke, brain damage, or vascular disease
• has an overactive thyroid, diabetes, or glaucoma (high eye pressure)
• has a pheochromocytoma (a tumor in the adrenal gland)
• has low levels of potassium in the blood or high levels of calcium in the blood
• has a tumor in the prostate gland or kidney disease
• is in shock or has lost a lot of blood
• is undergoing surgery with general anesthesia
• suffers from hypertension
• has arteriosclerosis, i.e., a narrowing and hardening of the blood vessels in the body (may advise you, your doctor).

If you or your child suffer from any of the above conditions, inform your doctor before this medication is administered.

Other medications and Adrenalina Ethypharm

Inform your doctor or nurse if you are taking, have taken recently, or may take other medications, including over-the-counter medications.

Many medications can interact with Adrenalina Ethypharm and significantly alter its effects. These substances include:

• monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants such as imipramine or amitriptyline, both used to treat depression

• cardiac glycosides such as digoxin, used for heart failure

• guanetidine, used for rapid blood pressure control
• diuretics, such as hydrochlorothiazide or furosemide
• general anesthetics by inhalation, such as halothane
• medications to increase or decrease blood pressure, including beta-blockers, e.g. propranolol, atenolol, bisoprolol, or fentolamine
• antidiabetic agents, such as insulin or oral hypoglycemic agents (e.g. glipizide)
• aminophylline and theophylline (medications to help breathe)
• corticosteroids (medications used to treat inflammatory conditions in the body, such as asthma or arthritis)
• antihistamines (e.g. diphenhydramine) for allergy treatment
• medications used to treat mental illnesses, such as chlorpromazine, perphenazine, or fluphenazine
• medications used to treat hypothyroidism
• oxytocin (used to induce labor and control bleeding after delivery)
• cough or cold remedies (sympathomimetics).

If you are already taking one of these medications, consult your doctor before Adrenalina Ethypharm is administered..

Pregnancy and breastfeeding

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

Adrenaline should only be used during pregnancy and breastfeeding if your doctor considers it essential.

Driving and operating machinery

You should not drive or operate machinery if Adrenalina Ethypharm has been administered..

Adrenalina Ethypharm contains metabisulfito de sodio and sodium chloride

This medication contains sodium metabisulfite, which can cause allergic reactions (hypersensitivity) in some people, leading to breathing difficulties or fainting. It is more likely that people with a history of asthma or allergies (hypersensitivities) will experience these problems.

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

Anaphylaxis

Your doctor will administer Adrenalina Ethypharm by intramuscular (IM) injection; however, in case of an emergency, a diluted injection may be administered intravenously (IV).

Adrenaline injections MUST NOT be applied in areas such as the fingers of the hands or feet, the ears, the nose, the genitals, or the buttocks, as it could affect blood flow to these areas. If repeated injections are required, your doctor must change the injection site.

It will be administered by a healthcare professional. Your doctor will decide on the most suitable dose and administration route for your case, taking into account your age and physical condition.

Adults

The usual dose is 0.5 ml. If necessary, this dose may be repeated several times at 5-minute intervals.

Geriatric patients

There are no specific dose regimens for adrenaline injection in geriatric patients, although adrenaline should be used with extreme caution.

Pediatric population

The following doses of Adrenalina Ethypharm are recommended:

If necessary, these doses may be repeated several times at 5-15 minute intervals, depending on blood pressure, pulse, and respiratory function.

A low-volume syringe should be used.

Cardiac arrest (cardiopulmonary resuscitation)

Adults

1 mg intravenously every 3-5 minutes.

Pediatric population

10 micrograms/kg intravenously or intraosseously. The maximum single dose is 1 mg.

If you believe you have been given too much Adrenalina Ethypharm

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.

Since this medication will be administered in a hospital, it is unlikely that you will receive too little or too much; however, speak with your doctor or nurse if you have any doubts.

Like all medications, Adrenalina Ethypharmmay cause side effects, although not everyone will experience them.

If you experience any of the following side effects, discontinue use of the medication and inform your doctor immediately:

• allergic reactions, although severe allergic reactions are rare

• difficulty breathing, swelling of the eyelids, face, or lips, hives, or itching (especially if it affects the entire body).

Other side effects (unknown: cannot be estimated from available data):

• headache
• dizziness
• anxiety, fear, or agitation sensations
• shakiness
• insomnia, confusion, irritability
• abnormal behavior or mood
• dry mouth or excessive saliva production
• weakness or sweating
• changes in heart rate and rhythm

• palpitations (rapid or irregular heartbeat), tachycardia (abnormally fast resting heart rate), angina (chest pain of varying intensity)

• hypertension
• coolness of the upper or lower extremities
• shortness of breath
• reduced appetite, nausea, or vomiting
• repeated injections may damage tissues at the injection site,
• fluid retention
• may cause metabolic acidosis (a blood component imbalance)
• cerebral hemorrhage
• paralysis of one side of the body
• increased blood sugar levels
• body fat decomposition
• reduced blood potassium levels
• pulmonary edema
• chest pain (acute angina)
• heart attack (acute myocardial infarction)
• pale appearance (pallor)
• syncope (fainting)
• mydriasis (pupil dilation)

In patients with Parkinson's disease, adrenaline may increase stiffness and tremors.

You may experience a mild pain, minor bruises or bleeding, or residual liquids at the injection site after receiving this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side 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 label after CAD. The expiration date is the last day of the month indicated.

Store the ampule in the outer packaging to protect it from light.

Do not store at a temperature above 25°C. Do not freeze.

Once diluted, the ready-to-use solution must be administered as soon as possible.

Do not administer Adrenalina Ethypharm if it has already been used or shows visible signs of damage.

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

Composition of Adrenaline Ethypharm

• The active ingredient is epinephrine (adrenaline) (as tartrate acid), 1 mg per ml.
• The other components are sodium chloride, sodium metabisulphite, and water for injection. It may be possible to add hydrochloric acid and sodium hydroxide to adjust the acidity.

Appearance of the product and contents of the package

Adrenaline Ethypharm is a colourless, clear solution supplied in a pack with 10 glass ampoules, each of which contains 0.5, 1, 2, 5 or 10 ml.

Only some sizes of packaging may be marketed.

Holder of the marketing authorisation and manufacturer responsible:

Holder of the marketing authorisation:

Ethypharm

194 Bureaux de la Colline, Building D

92213 Saint-Cloud CEDEX

France

Manufacturer responsible:

ETHYPHARM,

Chemin de la Poudrière, GRAND QUEVILLY,
76120,France

Or

ETHYPHARM,

Industrial Zone of Saint-Arnoult,
CHATEAUNEUF EN THYMERAIS,

28170,France

This medicinal product has marketing authorisation in the Member States of the EEA with the following names:

Last review date of this leaflet:July 2024

Other sources of information

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

The following information is intended only for healthcare professionals:

Preparation and handling:

Do not use Adrenaline Ethypharm 1mg/ml injectable solutionif you detect that it has discoloured.

Repeated local administration may cause necrosis at the injection site.

The best point for intramuscular injection is in the anterolateral area, in the middle third of the thigh. The needle used for injection should be long enough to ensure that the adrenaline reaches the muscle.

Injection into the muscles of the fingers of the hands and feet, the ears, the nose, the genitals or the buttocks should be avoided due to the risk of tissue necrosis.

Prolonged administration may cause metabolic acidosis, renal necrosis or tachyphylaxis.

Use of adrenaline injections or administer with extreme caution in patients undergoing general anaesthesia with halothane or other halogenated anaesthetics, due to the risk of developing ventricular fibrillation.

Do not mix with other medicines unless compatibility has been confirmed.

Do not use adrenaline injections during the second stage of labour.

Intravascular accidental injection may lead to cerebral haemorrhage due to the sudden increase in blood pressure.

The patient should be monitored as soon as possible (heart rate, blood pressure, ECG, pulse oximetry) to evaluate the response to adrenaline.

Incompatibilities

Adrenaline/epinephrine is quickly denatured by oxidising agents and alkalines, including sodium bicarbonate, halogens, nitrates, nitrites and iron, copper and zinc salts.

Dilution

For intravenous administration, Adrenaline Ethypharm should be diluted to a solution of 0.1 mg/ml (a 1:10 dilution of the contents of the ampoule) with sodium chloride 0.9% solution.

Dosage and administration

Anaphylaxis

Adrenaline Ethypharm is intended for intramuscular use.

Do not administer Adrenaline Ethypharm 1mg/ml without dilution.

The administration of adrenaline by intravenous route for the treatment of anaphylaxis requires the use of a solution of adrenaline 0.1mg/ml.

The IM route is generally preferred in the initial treatment of anaphylaxis, the IV route is generally more appropriate in the Intensive Care Unit or in the Emergency Department environment. Adrenaline Ethypharm 1mg/ml is not suitable for intravenous use. If adrenaline 0.1 mg/ml is not available, Adrenaline Ethypharm should be diluted to 0.1 mg/ml (1:10000) before intravenous use. The intravenous route for adrenaline injection should be used with extreme caution and is best reserved for specialists familiar with the intravenous use of adrenaline.

The intramuscular route is the preferred route of administration for most people who need adrenaline treatment in case of acute anaphylaxis.

The usual dose for adults is 0.5 mg (0.5 ml of adrenaline 1 mg/ml). If necessary, this dose may be repeated several times at intervals of 5 minutes, depending on blood pressure, pulse and respiratory function.

Older patients:

No established dosage regimens are available for adrenaline injections in older patients. However, in these patients, adrenaline should be used with extreme caution, as they may be more prone to the adverse cardiovascular effects of adrenaline.

Pediatric population

The following doses of Adrenaline Ethypharm are recommended:

When the patient is in a critical state and there is a real doubt about the sufficiency of circulation and absorption from the i.m. injection site, Adrenaline Ethypharm may be administered by intravenous injection (i.v.).

Adrenaline intravenous should only be administered by experienced people in the use and adjustment of vasopressors in their usual clinical practice (see section 4.4 of SPC). In the case of adrenaline intravenous, the dose should be adjusted with 50 microgram boluses according to the response. This dose can only be administered with a solution of 0.1 mg/ml (i.e. a 1:10 dilution of the contents of the ampoule). The undiluted adrenaline solution of 1 mg/ml should not be administered by i.v.

In the case of repeated doses of adrenaline, it is recommended to administer an i.v. infusion of adrenaline with adjustment of the rate according to the response in the presence of continuous haemodynamic monitoring.

Cardiopulmonary resuscitation

Adults

1 mg of adrenaline by intravenous injection repeated every 3-5 minutes.

If injected through a peripheral vein, it should be followed by a flush of at least 20 ml of sodium chloride 0.9% solution for injection (to facilitate the arrival of the medication in the central circulation).

If no venous access is available, intraosseous administration is recommended.

Pediatric population

The recommended intravenous or intraosseous dose of adrenaline in children is 10 micrograms/kg. Depending on the weight, this dose may need to be administered with a solution of 0.1 mg/ml (i.e. a 1:10 dilution of the contents of the ampoule). Further doses of adrenaline may be administered every 3-5 minutes. The maximum single dose is 1 mg.

Further doses may be repeated several times at intervals of 5-15 minutes, depending on blood pressure, pulse and respiratory function.

A low-volume syringe should be used.

Elimination

Unused medicines and residues should be disposed of in accordance with local regulations.

Overdose

Signs:

A overdose of Adrenaline Ethypharm causes severe hypertension. Accidents such as cerebral, cardiac or vascular may occur with potential fatal consequences (cerebral haemorrhage, arrhythmias such as transient bradycardia followed by tachycardia, which may lead to arrhythmia, myocardial necrosis, acute pulmonary oedema or renal insufficiency).

Treatment

The effects of adrenaline can be counteracted, depending on the patient's condition, by administering rapid-acting vasodilators, rapid-acting alpha-adrenergic receptor antagonists (e.g. fentolamine) or beta-adrenergic receptor antagonists (e.g. propranolol). However, due to the short half-life of adrenaline, it may not be necessary to administer these medicines. In the case of prolonged hypotensive reactions, it may be necessary to administer another vasopressor, such as noradrenaline.