Prospect: information for the user

Efedrina Aguettant 3 mg/ml, injectable solution in pre-filled syringes

Efedrine hydrochloride

(From now on “Efedrine injectable”)

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult with your doctor, pharmacist or nurse.
• This medication has been prescribed to you alone and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

1. What isEfedrine injectableand for what it is used

2. What you need to know before starting to useEfedrine injectable

3. How to useEfedrine injectable

4. Possible adverse effects

5. Conservation ofEfedrine injectable

6. Contents of the package and additional information

This medication is used for themanagementof low blood pressureinduced by anesthesia.

No use Efedrina inyectable:

• If you are allergic to hydrochloride of ephedrine or to any of the other components of this medication (listed in section 6).
• If you are taking other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine (medications used to relieve nasal congestion) or methylphenidate (medication used to treat attention deficit hyperactivity disorder (ADHD)).
• If you are taking an alpha-adrenergic agonist (medication used to treat arterial hypotension).
• If you are taking or have taken a non-selective monoamine oxidase inhibitor (medication used to treat depression) in the last 14 days.

Warnings and precautions

Consult with your doctor before starting to use Ephedrine injectable:

• If you are diabetic.
• If you have any cardiovascular disease, including angina.
• If you have weakness in the wall of blood vessels that causes a bulge (aneurysm).
• If you have high blood pressure.
• If you have vascular occlusive diseases (diseases that cause blockage of blood vessels).
• If you have an overactive thyroid gland (hyperthyroidism).
• If you know or suspect that you may have glaucoma (increased eye pressure) or benign prostatic hyperplasia (enlarged prostate gland).
• 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.

Use of Ephedrine injectable with other medications

Inform your doctor if you are using, have used recently or may need to use any other medication.

This information is especially important with the following medications:

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

Pregnancy and lactation

During pregnancy, the use of ephedrine should be avoided and used with caution, and only when necessary.

Depending on your condition, and following the doctor's recommendations, breastfeeding may be suspended for several days after administration of ephedrine.

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

Interference with diagnostic tests

This medication contains an active ingredient that may induce positive results in antidoping controls.

Ephedrine injectable contains sodium

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

Your doctor or nurse will administer this medication through a vein (intravenous route).

Your doctor will decide on the appropriate dose and when to administer the injection.

The recommended dose is:

Adults and elderly people

You will be given a slow injection of 3 to 6 mg (maximum 9 mg) through a vein, repeated as needed, 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

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

• Children over 12 years

Theposology andmethod of administration is 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 medication, consult your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The most severe adverse effects that require immediate medical attention are:

• Abnormal heart rhythm.
• Palpitations, high blood pressure, rapid heart rate.
• Chest pain, slow heart rate, low blood pressure.
• Heart failure (cardiac arrest).
• Cerebral hemorrhage.
• Pulmonary edema (fluid accumulation between the lungs).
• Increased eye pressure (glaucoma).
• Difficulty urinating.

The following are other adverse effects that may be experienced.

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

• Confusion, worry, depression;
• Nervousness, irritability, restlessness, weakness, insomnia, headache, sweating;
• Shortness of breath;
• Nausea, vomiting.

Unknown Frequency(cannot be estimated from available data):

• Affects blood coagulation.
• Allergy.
• Changes in personality or mood, fear.
• Tremor, excessive saliva production.
• Decreased appetite.
• Reduction in blood potassium levels, change in blood glucose levels.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the syringe label. Your doctor or nurse will verify this information.

Store the blister pack inside the box to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the pharmacy take-back point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ephedrine injectable

• The active ingredient is hydrochloride of ephedrine. Each milliliter of the injectable solution contains 3 mg of hydrochloride of ephedrine. Each preloaded syringe of 10 ml contains 30 mg of hydrochloride of ephedrine.

• The other components are sodium chloride, monohydrate of citric acid, 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 packaging

Ephedrine injectable is a transparent and colorless liquid. It is presented in a 10 ml polipropylene syringe preloaded with a polipropylene cap and a safety seal, individually packaged in a transparent blister.

The preloaded syringes are available in boxes of 1, 5, 10, 12 and 20 syringes.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratoire Aguettant

1, rue Alexander Fleming

69007 LYON

France

Responsible for manufacturing:

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 last review of this leaflet:December 2022.

The detailed information of this medicine is available on the website oftheSpanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).