Leaflet: information for the user

Adrenalina Basi 1 mg/ml injectable solution

epinephrine

Read this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you are given Adrenalina Basi

3.How to administer Adrenalina Basi

4.Possible side effects

1. Storage of Adrenalina Basi

6.Contents of the pack and additional information

Adrenaline belongs to a class of medications known as adrenergics and dopaminergics.

Adrenalina Basi is used in life-threatening emergencies such as severe allergic reactions or cardiac arrest.

No use Adrenalina Basi

-if you are allergic to adrenaline or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before Adrenalina Basi is administered to you if:

• you are an elderly person;
• you have heart problems, especially if they affect heart rate or if you experience chest pain;
• you have brain problems (e.g., stroke, brain damage, or vascular disease);
• you have hyperthyroidism, diabetes, or glaucoma (high eye pressure);
• you have pheochromocytoma (a tumor in the adrenal gland);
• you have low blood potassium levels or high calcium levels;
• you have a prostate gland tumor or kidney disease;
• you are in shock or have lost a lot of blood;
• you are about to undergo surgery with general anesthesia;
• you have high blood pressure;
• you have atherosclerosis, which is a narrowing and hardening of the blood vessels (your doctor will inform you about this).

Speak with your doctor if any of these circumstances apply before this medication is administered to you.

Other Medications and Adrenalina Basi

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

A large number of medications can interact with Adrenalina Basi, which may significantly alter its effects. These medications include:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or tricyclic antidepressants such as imipramine, amitriptyline, both used for depression;
• catechol-O-methyltransferase inhibitors (COMT) such as entacapone, tolcapone, opicapone, used to treat Parkinson's disease symptoms;
• cardiac glycosides such as digoxin, used for heart failure;
• guanethidine, used for rapid blood pressure control;
• diuretics, such as hydrochlorothiazide, furosemide;
• inhaled general anesthetics, such as halothane;
• medications to increase or decrease blood pressure, including beta-blockers, such as propranolol, atenolol, bisoprolol, fentolamine;
• antidiabetic medications such as insulin or oral hypoglycemics (e.g., glipizide);
• aminophylline and theophylline (medications used to treat asthma);
• corticosteroids (medications used to treat inflammatory conditions of the body such as asthma or arthritis);
• antihistamines (e.g., diphenhydramine), used for allergy treatment;
• medications used to treat mental illness such as chlorpromazine, perphenazine, or fluphenazine;
• medications used to treat hypothyroidism;
• oxytocin (used to induce labor and control bleeding after delivery);
• any cough or cold remedy (sympathomimetics).

If you are already taking any of these medications, speak with your doctor before receiving Adrenalina Basi.

Pregnancy and Breastfeeding

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

Adrenalina Basi should not be used during pregnancy and delivery.

Adrenaline is excreted in breast milk. If you are breastfeeding, speak with your doctor before receiving Adrenalina Basi.

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

Driving and Operating Machinery

It is unlikely that this will be applicable, as you will not be in a fit state to drive or operate machinery.

Consult your doctor before considering this measure.

Adrenalina Basi contains sodium metabisulfite and sodium chloride

Sodium metabisulfite (a preservative) rarely may cause severe hypersensitivity reactions and bronchospasm.

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

Adrenalina Basi may be diluted in sodium chloride 0.9%, glucose 5%, glucose 5% in sodium chloride 0.9%. This fact should be taken into account in patients following a low-sodium diet.

Adrenaline can be injected into a muscle (intramuscularly) or a bone (intraosseously). It must be diluted before injection into a vein.

Adrenaline injection should not be used in areas such as the fingers of the hands or feet, the ears, the nose, or the penis, as blood flow to these areas may become insufficient.

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

If you believe you have been administered more Adrenalina Basi than you should have

It is unlikely, as the injection will be administered by a doctor or nurse.

Possible signs of overdose include restlessness, confusion, pallor, abnormally rapid heart rate at rest (tachycardia), abnormally slow heart rate (bradycardia), irregular heart rate (cardiac arrhythmias), and cardiac arrest.

Consult your doctor if you experience any adverse effects, so that they can provide you with appropriate treatment. If you have already left the medical center, contact your nearest hospital, doctor, or pharmacist.

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

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

The following adverse effects have also been reported (unknown frequency):

• headache, dizziness;
• sensation of anxiety or fear or unease;
• trembling;
• insomnia, confusion, irritability;
• mood or behavior changes;
• dry mouth or excessive saliva production;
• weakness or sweating;
• changes in heart rhythm and speed;
• palpitations (rapid or irregular heartbeat), tachycardia (abnormally fast resting heart rate), angina (chest pain of varying intensity);
• high blood pressure;
• coldness in the arms or legs;
• difficulty breathing;
• reduced appetite, nausea, or vomiting;
• repeated injections may damage tissues at the injection site and may also cause damage to the extremities, kidneys, and liver;
• difficulty urinating, urinary retention;
• metabolic acidosis (an imbalance of certain blood components) may occur;
• increased tremors and stiffness in patients with a known condition called Parkinson's syndrome;
• intracranial hemorrhage;
• paralysis of one side of the body;
• increased blood sugar levels;
• reduced potassium levels in the blood;
• pulmonary edema.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

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

Store below 25°C. Store ampules in the outer packaging to protect them from light.

For single use only. If only part of an ampule is used, the remaining solution must be discarded.

Do not remove the ampule from the box until ready for use.

After dilution, the ready-to-use solution must be administered as soon as possible.

Only transparent, particle-free, or precipitate-free solutions should be used.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Adrenaline Base Composition

• The active principle is epinephrine (adrenaline) in the form of epinephrine tartrate (adrenaline). Each 1 ml of this injection solution contains 1 mg of epinephrine (adrenaline) in the form of adrenaline tartrate.
• The other components (excipients) are sodium chloride, sodium metabisulphite (E223) and water for injection preparations.

Appearance of the product and contents of the package

Adrenaline Base is a transparent and sterile injectable solution, in type I glass vials of amber color of 1 ml.

Adrenaline Base is available in packs of 10 and 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel.: + 351 231 920 250 | Fax: + 351 231 921 055

E-mail: [email protected]

Responsible for manufacturing

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16

3450-232 Mortágua

Portugal

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid)

This medication is authorized in the member states of the European Economic Area with the following names:

PortugalAdrenalina Basi

SpainAdrenalina Basi 1 mg/ml injectable solution

Last review date of this leaflet: July 2023

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

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Preparation and handling:

Only transparent, particle-free, or precipitate-free solutions should be used.

Repeated local administration may cause necrosis at the injection sites.

The best place for intramuscular injection is the anterolateral part of the middle third of the thigh. Injections intramuscularly in the buttocks should be avoided due to the risk of tissue necrosis.

Incompatibilities:

Do not mix Adrenaline Base with other medications, unless compatibility is known.

For intravenous administration, Adrenaline Base should be diluted to a 0.1 mg/ml solution (a 1:10 dilution of the ampoule contents) with sodium chloride 0.9%, glucose 5%, or glucose 5% in sodium chloride 0.9%.

Dosage and administration:

This medication will be administered by a trained healthcare professional.

Adrenaline Base is for intravenous, intraosseous, intramuscular, or subcutaneous administration.

For intravenous administration, only after dilution.

Acute anaphylaxis

The intramuscular (IM) route is the preferred route for most people who need to receive adrenaline for the treatment of acute anaphylaxis.

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

The best place for IM injection is the anterolateral part of the middle third of the thigh.

The needle used for injection should be long enough to ensure that the adrenaline is injected into the muscle.

The subcutaneous route is not recommended for adrenaline in the treatment of anaphylactic reactions, as it is less effective.

Adults

The usual dose is 0.5 mg (0.5 ml of adrenaline 1 mg/ml (1:1000)). If necessary, this dose can be repeated several times at intervals of 5 minutes, depending on blood pressure, pulse, and respiratory function.

Older adults:

No specific dosing regimens are recommended for the injection of adrenaline in elderly patients. However, adrenaline should be used with caution in these patients, who may be more susceptible to the cardiovascular effects of adrenaline.

Children

The following doses of Adrenaline 1 mg/ml (1:1000) injectable solution are recommended:

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

A small-volume syringe should be used.

Cardiopulmonary resuscitation

Adults

1 mg of adrenaline by intravenous or intraosseous route repeated every 3-5 minutes until spontaneous circulation is restored. If administered through a peripheral vein, it should be followed by a flush of at least 20 ml of fluid.

Children

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

Administration

Adrenaline 1 mg/ml (1:1000) injectable solution can be administered by the IM, IV, and IO routes.

The dose should be adjusted with 50 microgram boluses, depending on response. This dose can only be administered with a 0.1 mg/ml solution (i.e., a 1:10 dilution of the ampoule contents). For instructions on diluting the medication before administration, see section 6.6. The undiluted adrenaline solution of 1 mg/ml should not be administered intravenously.

For repeated doses of adrenaline, a continuous intravenous infusion of adrenaline with adjustment of the rate inresponse to hemodynamic control is recommended.