Ephedrinum Hidrohloricum Aguettant

Leaflet attached to the packaging: information for the user

Ephedrinum hydrochloricum Aguettant, 3 mg/ml, solution for injection in a pre-filled syringe

Syringe
ephedrine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ephedrinum hydrochloricum Aguettant and what is it used for
• 2. Important information before using Ephedrinum hydrochloricum Aguettant
• 3. How to use Ephedrinum hydrochloricum Aguettant
• 4. Possible side effects
• 5. How to store Ephedrinum hydrochloricum Aguettant
• 6. Package contents and other information

1. What is Ephedrinum hydrochloricum Aguettant and what is it used for

This medicine is used to control low blood pressure caused by anesthesia.

2. Important information before using Ephedrinum hydrochloricum

Aguettant

When not to use Ephedrinum hydrochloricum Aguettant:

• if the patient is allergic to ephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking another indirect sympathomimetic agent, such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used in treatment of rhinitis) or methylphenidate (a medicine used in treatment of attention deficit hyperactivity disorder (ADHD));
• if the patient is taking an alpha sympathomimetic agent (medicines used in treatment of low blood pressure);
• if the patient is taking or has taken within the last 14 days non-selective monoamine oxidase inhibitors (medicines used in treatment of depression).

Warnings and precautions

Before using Ephedrinum hydrochloricum Aguettant, you should discuss it with your doctor:

• if the patient has diabetes;
• if the patient has heart disease or any other heart condition, including angina pectoris;
• if the patient has a weakness of the blood vessel wall leading to the formation of an aneurysm;
• if the patient has high blood pressure;
• if the patient has narrowing and/or blockage of blood vessels (arteriosclerosis);
• if the patient has hyperthyroidism;
• if the patient has or is suspected of having glaucoma (increased eye pressure) or prostatic hyperplasia (enlarged prostate);
• if the patient is going to have surgery that requires anesthesia;
• if the patient is currently taking or has taken within the last 14 days any monoamine oxidase inhibitors used in the treatment of depression.

Ephedrinum hydrochloricum Aguettant and other medicines

You should tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is especially important for the following medicines:

• methylphenidate, used in the treatment of attention deficit hyperactivity disorder (ADHD);
• indirect stimulants of the sympathetic nervous system, such as phenylpropanolamine or pseudoephedrine (medicines used in rhinitis) and phenylephrine (a medicine used in the treatment of low blood pressure);
• direct stimulants of alpha receptors of the sympathetic nervous system (administered orally and/or intranasally), used, among other things, in the treatment of low blood pressure and rhinitis;
• medicines used in the treatment of depression;
• ergot alkaloids, a type of medicine used as vasoconstrictors or due to their dopaminergic effect (increasing dopamine-dependent brain activity);
• linezolid, used in the treatment of infections;
• guanethidine and related medicines, used in the treatment of high blood pressure;
• sibutramine, a medicine used to suppress appetite;
• inhalation anesthetics, such as halothane;
• medicines used in the treatment of asthma, such as theophylline;
• corticosteroids, a type of medicine used to alleviate swelling caused by various reasons;
• medicines for epilepsy;
• doxapram, a medicine used in the treatment of respiratory disorders;
• oxytocin, a medicine used during childbirth;
• reserpine and methyldopa and related medicines, used in the treatment of high blood pressure.

Pregnancy and breastfeeding

Ephedrine should be avoided during pregnancy or used with caution and only when necessary.
Depending on the patient's condition and in accordance with the doctor's recommendations, breastfeeding may be suspended for a few days after administration of ephedrine.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor, pharmacist, or nurse before using this medicine.

Laboratory tests

This medicine contains an active substance that may give positive results in anti-doping tests.

Ephedrinum hydrochloricum Aguettant contains sodium

This medicine contains 33.9 mg of sodium (the main component of common salt) in each 10 ml pre-filled syringe.
This corresponds to 1.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ephedrinum hydrochloricum Aguettant

The doctor or nurse will administer Ephedrinum hydrochloricum Aguettant to the patient's vein (intravenously).
The doctor will determine the appropriate dose for the patient and the time and method of injection.

Recommended doses are:

Adults and the elderly

The patient will receive a slow injection of 3 to 6 mg (up to 9 mg) into the vein, which will be repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

Use in children and adolescents

• Children under 12 years of age Ephedrinum hydrochloricum Aguettant, 3 mg/ml, solution for injection in a pre-filled syringe is not recommended for use in children under 12 years of age due to the lack of sufficient data on efficacy, safety, and recommended dose.
• Children from 12 years of age The dosing and method of administration are the same as for adults.

Patients with renal or hepatic impairment:

There is no need to adjust the dose in patients with renal or hepatic impairment.
If you have any further doubts about the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects that will require immediate medical attention include:

• abnormal heart rhythm;
• palpitations, high blood pressure, rapid heartbeat;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• intracranial hemorrhage;
• fluid accumulation in the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• difficulty urinating.

Other side effects that may occur when taking this medicine are listed below.
Frequent(may occur in up to 1 in 10 patients):

• confusion, feeling of unease, depression;
• nervousness, irritability, anxiety, weakness, sleep problems, headache, sweating;
• shortness of breath;
• nausea, vomiting.

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

• blood coagulation disorders;
• allergy;
• changes in personality or way of thinking or feeling, anxiety;
• tremors, excessive salivation;
• decreased appetite;
• low potassium levels in the blood, changes in blood glucose levels.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ephedrinum hydrochloricum Aguettant

The medicine should be stored out of sight and reach of children.
The patient should not receive this medicine if the expiry date on the carton and syringe label has passed.
The doctor or nurse will check the expiry date.
Store the blister with the pre-filled syringe in the carton to protect it from light.
Any unused product or waste should be disposed of in accordance with local regulations.

6. Package contents and other information

What Ephedrinum hydrochloricum Aguettant contains

• The active substance is ephedrine hydrochloride. Each milliliter of the solution for injection contains 3 mg of ephedrine hydrochloride. Each 10 ml pre-filled syringe contains 30 mg of ephedrine hydrochloride.
• The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate, and water for injections. The medicine may also contain hydrochloric acid or sodium hydroxide (to adjust the pH).

What Ephedrinum hydrochloricum Aguettant looks like and what the pack contains

Ephedrinum hydrochloricum Aguettant is a clear and colorless solution. The medicine is supplied in a 10 ml pre-filled syringe made of polypropylene with a polypropylene stopper and a tamper-evident system, packaged individually in a transparent blister.
The pre-filled syringes are available in cartons of 1, 5, 10, 12, and 20. Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet: 12/2022

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.