EFEDRINA AGUETTANT 3 mg/ml INJECTABLE SOLUTION IN PRE-FILLED SYRINGES

Introduction

Package Leaflet: Information for the User

Efedrina Aguettant 3 mg/ml, Solution for Injection in Pre-filled Syringes

Ephedrine Hydrochloride

(Hereafter referred to as “Ephedrine Injectable”)

Read all of this leaflet carefully before you start using 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 experience 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 Ephedrine Injectable and what is it used for
2. What you need to know before you use Ephedrine Injectable
3. How to use Ephedrine Injectable
4. Possible side effects
5. Storage of Ephedrine Injectable
6. Contents of the pack and further information

1. What is Ephedrine Injectable and what is it used for

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

2. What you need to know before you use Ephedrine Injectable

Do not use Ephedrine Injectable:

• If you are allergic to ephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other 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 alpha sympathomimetic agent (a medicine used to treat low blood pressure).
• If you are taking or have taken in the last 14 days a non-selective monoamine oxidase inhibitor (a medicine used to treat depression).

Warnings and Precautions

Consult your doctor before using Ephedrine Injectable:

• If you are diabetic.
• If you have any cardiovascular disease, including angina.
• If you have weakness in the blood vessel walls that causes a bulge (aneurysm).
• If you have high blood pressure.
• If you have narrowing or blockage of the blood vessels (occlusive vascular disease).
• If you have an overactive thyroid gland (hyperthyroidism).
• If you know or suspect you may have glaucoma (increased eye pressure) or an enlarged prostate gland (prostatic hypertrophy).
• If you are about to undergo surgery that requires anesthesia.
• If you are currently taking or have taken in the last 14 days any monoamine oxidase inhibitor to treat depression.

Using Ephedrine Injectable with Other Medicines

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

This information is especially important with the following medicines:

• methylphenidate, used to treat Attention Deficit Hyperactivity Disorder (ADHD).
• indirect sympathomimetic stimulants such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants) or phenylephrine (a medicine used to treat low blood pressure).
• direct alpha receptor stimulants (oral and/or nasal) used to treat low blood pressureor nasal congestion, among others.
• medicines used to treat depression.
• ergot alkaloids, a type of medicine used as a vasoconstrictoror to increase dopaminergic activityin 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.
• inhalational anesthetics, such as halothane.
• medicines used to treat asthma, such as theophylline.
• corticosteroids, a type of medicine used to relieve inflammationin a wide range 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

The use of 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 be suspended for several days after administration of ephedrine.

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

Interference with Diagnostic Tests

This medicine contains an active ingredient that may cause positive results in doping tests.

Ephedrine Injectable contains Sodium

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

3. How to use Ephedrine Injectable

Your doctor or nurse will administer this medicine to you through a vein (intravenously).

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

The recommended dose is:

Adults and Elderly

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 should not exceed 150 mg in 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 due to insufficient data on efficacy, safety, and dosage recommendations.

• Children over 12 years

The dosage and method of administration are the same as for 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 Side Effects

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

The most serious side effects that require immediate medical attention are:

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

The following are other side effects that you might experience.

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

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

Frequency Not Known(cannot be estimated from the available data):

• affects blood coagulation.
• allergy.
• changes in personality or the way you feel or think, fear.
• tremor, excessive saliva production.
• decreased appetite.
• reduction in blood potassium levels, change in blood glucose levels.

Reporting of Side Effects

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

5. Storage of Ephedrine Injectable

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 syringe. Your doctor or nurse will check this.

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

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

6. Contents of the Pack and Further Information

Composition of Ephedrine Injectable

• 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. It may also contain hydrochloric acid or sodium hydroxide (for pH adjustment).

Appearance of the Product and Pack Size

Ephedrine Injectable is a clear, colorless liquid. It is provided in a 10 ml polypropylene syringe with a polypropylene cap and a security seal, packaged individually in a transparent blister.

The pre-filled syringes are available in packs of 1, 5, 10, 12, and 20 syringes.

Not all 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 Last 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/).