ADRENALINE BASIC 1 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Adrenaline Basi 1 mg/ml Solution for Injection

Epinephrine

Read all of this leaflet carefully before you are given 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, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Adrenaline Basi and what is it used for
2. What you need to know before you are given Adrenaline Basi
3. How Adrenaline Basi is given
4. Possible side effects
   1. Storage of Adrenaline Basi

1. Contents of the pack and further information

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

Adrenaline belongs to a class of medicines called adrenergic and dopaminergic agents.

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

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

Do not use Adrenaline Basi

• if you are allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you are given Adrenaline Basi if:

• you are elderly;
• you have heart problems, especially if they affect your heart rate or if you have chest pain;
• you have brain problems (e.g., stroke, brain damage, or blood vessel disease);
• you have hyperthyroidism, diabetes, or glaucoma (high pressure in the eye);
• you have pheochromocytoma (a tumor in the adrenal gland);
• you have low blood potassium levels or high calcium levels;
• you have a tumor in the prostate gland or kidney disease;
• you are in shock or have lost a lot of blood;
• you are going to have 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 tell you).

Talk to your doctor if any of these conditions apply to you before you are given this medicine.

Other medicines and Adrenaline Basi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

A large number of medicines can interact with Adrenaline Basi, which can significantly alter its effects. These medicines include:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or tricyclic antidepressants such as imipramine, amitriptyline, both used for depression;
• catechol-O-methyltransferase (COMT) inhibitors, 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 control of blood pressure;
• diuretics, such as hydrochlorothiazide, furosemide;
• inhalational general anesthetics, such as halothane;
• medicines to increase or decrease blood pressure, including beta-blockers, such as propranolol, atenolol, bisoprolol, phentolamine;
• antidiabetics such as insulin or oral hypoglycemics (e.g., glipizide);
• aminophylline and theophylline (medicines used to treat asthma);
• corticosteroids (medicines used to treat inflammatory conditions of the body such as asthma or arthritis);
• antihistamines (e.g., diphenhydramine), used to treat allergies;
• medicines used to treat mental illness such as chlorpromazine, periciazine, or fluphenazine;
• medicines used to treat hypothyroidism;
• oxytocin (used to induce labor at term and to control bleeding after delivery);
• any cough or cold remedy (sympathomimetics).

If you are already taking any of these medicines, talk to your doctor before you are given Adrenaline Basi.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Adrenaline Basi should not be used during pregnancy and childbirth.

Adrenaline is excreted in breast milk. If you are breastfeeding, talk to your doctor before you are given Adrenaline Basi.

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

Driving and using machines

It is unlikely to be applicable, as you will not be well enough to drive or use machinery.

Talk to your doctor before considering such action.

Adrenaline Basi contains sodium metabisulfite and sodium chloride

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

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

Adrenaline Basi can 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 on a low-sodium diet.

3. How Adrenaline Basi is given

Adrenaline can be injected into a muscle (intramuscularly) or into 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, ears, nose, or penis, as the blood supply to these areas may become insufficient.

Adrenaline Basi will be given to you by a trained healthcare professional. Your doctor will decide the most suitable dose and route of administration for your specific case, based on your age and physical circumstances.

If you think you have been given too much Adrenaline Basi

This is unlikely, as the injection will be given to you by a doctor or nurse.

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

Talk to your doctor if you experience any side effects, so that they can give you appropriate treatment. If you have already left the hospital, contact your nearest hospital, doctor, or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects have also been reported (frequency not known):

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adrenaline Basi

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the ampoule after EXP. The expiry date is the last day of the month stated.

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

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

Do not remove the ampoule from the box until you are ready to use it.

After dilution, the solution should be administered as soon as possible.

Only clear solutions free from particles or precipitates should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Adrenaline Basi

• The active substance is epinephrine (adrenaline) as epinephrine tartrate. Each 1 ml of this solution for injection contains 1 mg of epinephrine (adrenaline) as epinephrine tartrate.
• The other ingredients (excipients) are sodium chloride, sodium metabisulfite (E223), and water for injections.

Appearance and packaging of the product

Adrenaline Basi is a clear, sterile solution for injection, in amber glass ampoules of type I, 1 ml.

Adrenaline Basi is available in packs of 10 and 50 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

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: basi@basi.pt

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

You can obtain further information on this medicine from 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal Adrenalina Basi

Spain Adrenalina Basi 1 mg/ml solution for injection

Date of last revision of this leaflet: July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS). (http://www.aemps.gob.es/)

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Preparation and handling:

Only clear solutions free from particles or precipitates should be used.

Repeated local administration can cause necrosis at the injection site.

The best place for intramuscular injection is the anterolateral aspect of the middle third of the thigh. Injections of Adrenaline Basi into the buttocks should be avoided due to the risk of tissue necrosis.

Incompatibilities:

Do not mix Adrenaline Basi with other medicines, unless compatibility is known.

For intravenous administration, Adrenaline Basi 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%.

Posology and method of administration:

This medicine will be administered by a trained healthcare professional.

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

For intravenous administration only after dilution.

Acute anaphylaxis

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.

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 0.1 mg/ml solution (i.e., a 1:10 dilution of the ampoule contents). Further doses of adrenaline may be administered every 3-5 minutes. The maximum single dose is 1 mg.

Method of administration

Adrenaline 1 mg/ml (1:1,000) solution for injection can be administered by the intramuscular, intravenous, and intraosseous routes.

The dose should be adjusted with 50 microgram boluses based 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 dilution of the medicine before administration, see section 6.6. The undiluted adrenaline solution of 1 mg/ml should not be administered intravenously.

In case of repeated doses of adrenaline, an intravenous infusion of adrenaline with adjustment of the rate based on response and under continuous hemodynamic monitoring is recommended.