Ephedrine Aguettant 3 mg/ml solution for injection in pre-filled syringes

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ephedrine Aguettant 3 mg/ml, solution for injection in pre-filled syringes

Ephedrine hydrochloride

(Hereinafter referred to as "Injectable Ephedrine")

Read the entire leaflet carefully before you start using 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Injectable Ephedrine is and what it is used for
2. What you need to know before using Injectable Ephedrine
3. How to use Injectable Ephedrine
4. Possible side effects
5. How to store Injectable Ephedrine
6. Contents of the pack and other information

1. What Efedrina inyectable is and what it is used for

This medicine is used for the management of low blood pressure caused by anesthesia.

2. What you need to know before using Efedrina injectable

Do not use Efedrina injectable:

• If you are allergic to ephedrine hydrochloride or to any of the other components of this medicine (listed in section 6).
• If you are concurrently taking other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used to relieve nasal congestion) or methylphenidate (a medicine used to treat “attention deficit hyperactivity disorder (ADHD)”).
• If you are taking an α-sympathomimetic agent (a medicine used to treat low blood pressure).
• If you are taking or have taken, within the last 14 days, a non-selective monoamine oxidase inhibitor (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor before using Efedrina injectable:

• If you have diabetes.
• If you have any cardiovascular disease, including angina.
• If you have weakness in the walls of your blood vessels causing a bulge (aneurysm).
• If you have high blood pressure.
• If you have stenosis and/or occlusion of blood vessels (occlusive vascular diseases).
• If you have an overactive thyroid gland (hyperthyroidism).
• If you know or suspect you may have glaucoma (increased eye pressure) or prostate enlargement (prostatic hypertrophy).
• If you are about to undergo surgery requiring anesthesia.
• If you are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor for the treatment of depression.

Use of Efedrina injectable with other medicines

Tell your doctor if you are using, have recently used, or might need to use any other medicine.

This information is especially important with the following medicines:

• methylphenidate, used to treat “attention deficit hyperactivity disorder (ADHD)”.
• indirect stimulants of the sympathetic nervous system such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants), or phenylephrine (a medicine used to treat low blood pressure).
• direct α-receptor stimulants of the sympathetic nervous system (oral and/or nasal use) used to treat low blood pressure or nasal congestion, among others.
• medicines used to treat depression.
• ergot alkaloids, a type of medicine used as vasoconstrictors (narrowing of blood vessels) or for dopaminergic action (increasing dopamine activity in the brain).
• linezolid, used to treat infections.
• guanethidine and related medicines, used to treat high blood pressure.
• sibutramine, a medicine used as an appetite suppressant.
• inhaled anesthetics, such as halothane.
• medicines used to treat asthma, such as theophylline.
• corticosteroids, a type of medicine used to reduce inflammation in a wide variety of different diseases.
• medicines for epilepsy.
• doxapram, a medicine used to treat respiratory problems.
• oxytocin, a medicine used during childbirth.
• reserpine, methyldopa, and related medicines, used to treat high blood pressure.

Pregnancy and breastfeeding

Ephedrine should be avoided during pregnancy and used with caution, only when necessary.

Depending on your condition and following your doctor’s recommendations, breastfeeding may need to be interrupted for several days after administration of ephedrine.

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

Interference with diagnostic tests

This medicine contains an active substance that may cause positive results in anti-doping controls.

Efedrina injectable contains sodium

This medicine contains 33.9 mg of sodium (main component of table/cooking salt) per 10 ml pre-filled syringe. This is equivalent to 1.7% of the maximum daily sodium intake recommended by the WHO for an adult.

3. How to use Injectable Ephedrine

Your doctor or nurse will administer this medicine into a vein (intravenous route).

Your doctor will decide the appropriate dose and when the injection should be given.

Recommended dose:

Adults and elderly patients

You will be given a slow injection of 3 to 6 mg (maximum 9 mg) into a vein, repeated if necessary every 3–4 minutes, up to a maximum of 30 mg.

The total dose must not exceed 150 mg within a 24-hour period.

Use in children and adolescents

• Children under 12 years

Ephedrine 3 mg/ml solution for injection in pre-filled syringe is not recommended for use in children under 12 years of age due to insufficient data on efficacy, safety, and dosing recommendations.

• Children over 12 years

The dosage and method of administration are the same as in adults.

Patients with kidney or liver disease

No dose adjustment is recommended for patients with kidney or liver disease.

For further information about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The most serious adverse effects requiring immediate medical attention are:

• abnormal heart rhythm.
• palpitations, high blood pressure, rapid heartbeat.
• chest pain, slow heartbeat, low blood pressure.
• heart failure (cardiac arrest).
• cerebral haemorrhage.
• fluid accumulation between the lungs (pulmonary edema).
• increased intraocular pressure (glaucoma).
• difficulty urinating.

Listed below are other adverse effects that may occur.

Frequent (may affect up to 1 in 10 people):

• confusion, anxiety, depression;
• nervousness, irritability, restlessness, weakness, insomnia, headache, sweating;
• shortness of breath;
• nausea, vomiting.

Frequency not known (cannot be estimated from available data):

• affects blood coagulation.
• allergy.
• changes in personality or in the way of feeling or thinking, fear.
• tremor, excessive salivation.
• decreased appetite.
• reduction in blood potassium levels, changes in blood glucose levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Injectable Ephedrine

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the syringe label. Your doctor or nurse will check this information.

Store the blister in the outer carton to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Injectable Ephedrine

• The active substance is ephedrine hydrochloride. Each millilitre of the injectable solution contains 3 mg of ephedrine hydrochloride. Each 10 ml pre-filled syringe contains 30 mg of ephedrine hydrochloride.

• The other components are sodium chloride, citric acid monohydrate, sodium citrate, and water for injections. It may also contain hydrochloric acid or sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the pack

Injectable ephedrine is a clear, colourless liquid. It is supplied in a 10 ml pre-filled polypropylene syringe with a polypropylene cap and a tamper-evident seal, individually packaged in a transparent blister.

Pre-filled syringes are available in cartons containing 1, 5, 10, 12 or 20 syringes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON
France

Manufacturer:

LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON
France

or

LABORATOIRE AGUETTANT
Lieu-dit “Chantecaille”
07340 CHAMPAGNE
France

Local Representative:

AGUETTANT IBERICA
C/Pau Claris, 139, Pral. 2
08009, Barcelona - Spain

Date of the most recent revision of this leaflet: December 2022.

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