Ephedrine Aguettant 3 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EphedrineAguettant 3 mg/ml solution for injection

ephedrine, hydrochloride

Read all of this 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.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

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

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

This medicine is an injectable solution in ampoules used for the treatment of low blood pressure during general and local/regional anesthesia, whether spinal or epidural, in adults and adolescents (over 12 years of age).

This product must be used exclusively by an anesthetist or under their supervision.

2. What you need to know before starting to use Ephedrine Aguettant

Do not use Ephedrine Aguettant if:

• you are allergic to ephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6),
• you are 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)”),
• you are taking an alpha-sympathomimetic agent (a medicine used to treat low blood pressure),
• 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 starting to use Ephedrine Aguettant if:

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

Other medicines and Ephedrine Aguettant

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

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 stimulants of the sympathetic nervous system alpha receptors (oral and/or nasal) used to treat hypotension (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 and methyldopa and related medicines, used to treat high blood pressure;
• cardiac glycosides, used to treat congestive heart failure and cardiac arrhythmias;
• quinidine, used to treat heart rhythm disorders;
• bicarbonate, used to treat metabolic acidosis or to alkalinize the urine.

Pregnancy and breastfeeding

During pregnancy, ephedrine should be avoided or used with caution, and 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 ingredient that may cause positive results in anti-doping tests.

Ephedrine Aguettant contains sodium

This medicine contains 33.5 mg of sodium (main component of table/cooking salt) per 10 ml ampoule. This corresponds to 1.7% of the maximum daily sodium intake recommended for an adult.

3. How to use Ephedrine Aguettant

Your doctor or nurse will administer this medicine through a vein (intravenous route). Your doctor will decide what the appropriate dose is and when and how 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

This medicine 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 more 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 experiences them.

The most serious adverse effects that require 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 hemorrhage;
• fluid accumulation between the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• difficulty urinating.

The following is a list of other adverse effects that may occur while using this medicine.

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

• 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 you feel or think, fear;
• tremor, excessive salivation;
• decreased appetite;
• reduction in blood potassium levels, changes in blood glucose levels.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Ephedrine Aguettant

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

Do not use this medicine after the expiry date stated on the packaging and on the label of the ampoule following EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Ephedrine Aguettant

• The active substance is ephedrine hydrochloride. Each ml of injectable solution contains 3 mg of ephedrine hydrochloride. Each 10 ml ampoule contains 30 mg of ephedrine hydrochloride.

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

Appearance of the product and contents of the pack

Ephedrine Aguettant 3 mg/ml solution for injection is a clear, colourless liquid. It is supplied in a 10 ml polypropylene ampoule.

This medicine is available in packs of 10 polypropylene ampoules.

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
Lieu-dit “Chantecaille”
07340 Champagne
France

or

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Further information on this medicine can be obtained by contacting the local representative of the Marketing Authorisation Holder:

Local Representative:

Aguettant Ibérica
Baldiri Reixac, 4-8, Torre I, 4º
08028 Barcelona, Spain

This medicine is authorised in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 08/2024.

Other sources of information

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

Information intended exclusively for healthcare professionals:

Overdose

In case of overdose, symptoms such as nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmia, hypertension, respiratory depression, seizures, and coma may occur.

Treatment

A slow intravenous injection of labetalol 50–200 mg with electrocardiographic monitoring may be administered for the treatment of supraventricular tachycardia. Marked hypokalemia (<2.8 mmol·l⁻¹) due to a transcellular shift of potassium predisposes to cardiac arrhythmia and can be corrected by infusion of potassium chloride, in addition to propranolol and correction of respiratory alkalosis, if present.

A benzodiazepine and/or a neuroleptic agent may be required to control central nervous system stimulant effects.

For severe hypertension, intravenous antihypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine.