Ephedrine Aguettant

Package leaflet: Information for the user

Efedrina Aguettant 3 mg/ml solution for injection in pre-filled syringe

ephedrine hydrochloride
(Hereinafter referred to in this leaflet as "Injectable Ephedrine")
Read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this 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 Iniettabile is and what it is used for

This medicinal product is used for the management of low blood pressure induced by
anaesthesia.

2. What you need to know before using Ephedrine Injectable

Do not use Ephedrine Injectable:

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

Warnings and precautions
Talk to your doctor before using Ephedrine Injectable:

• if you have diabetes;
• if you have heart disease or any cardiac condition, including angina;
• if you have weakened blood vessel walls leading to the formation of bulges (aneurysm);
• if you have high blood pressure;
• if you have narrowing or blockages in your blood vessels (occlusive vascular disorders);
• if you have overactivity of the thyroid gland (hyperthyroidism);
• if you have known or suspected conditions such as glaucoma (increased eye pressure) or benign prostatic hyperplasia (enlargement of the prostate gland);
• if you are about to undergo surgery requiring administration of an anesthetic;
• if you are currently taking or have taken within the last 14 days a monoamine oxidase inhibitor, a medicine used to treat depression.

For athletes: using this medicine without a therapeutic indication constitutes doping and may result in a positive anti-doping test.
Other medicines and Ephedrine Injectable
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
This is particularly important for the following medicines:

• methylphenidate, used for the treatment of “attention deficit/hyperactivity disorder (ADHD)”;
• indirect stimulants of the sympathetic nervous system such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants), phenylephrine (a medicine used for the treatment of hypotension);
• direct stimulants acting on alpha receptors of the sympathetic nervous system (oral and/or nasal use), used among others for the treatment of hypotension or nasal congestion;
• medicines used to treat depression;
• ergot alkaloids, a type of medicine used as vasoconstrictors (narrowing of blood vessels) or for their dopaminergic action (increasing dopamine-related activity in the brain);
• linezolid, indicated for the treatment of infections;
• guanethidine and related medicines, used for the treatment of high blood pressure;
• sibutramine, a medicine used as an appetite suppressant;
• inhaled anesthetics such as halothane;
• medicines used for the treatment of asthma, such as theophylline;
• corticosteroids, a type of medicine used to reduce swelling in various conditions;
• medicines for epilepsy;
• doxapram, a medicine used for the treatment of respiratory problems;
• oxytocin, a medicine used during labor;
• reserpine, methyldopa, and related medicines, used to treat high blood pressure.

Pregnancy and breastfeeding
Ephedrine should be avoided or used with caution and only if necessary during pregnancy.
Depending on your condition and following your doctor’s recommendation, breastfeeding should be discontinued for several days after administration of ephedrine.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before receiving this medicine.
Laboratory tests
This medicine contains an active substance that may lead to positive results in anti-doping controls.
Ephedrine Injectable contains sodium
This medicine contains 33.9 mg of sodium (a main component of table salt) in each 10 ml pre-filled syringe. This corresponds to 1.7% of the maximum daily recommended dietary intake for an adult.

3. How to use Ephedrine Injectable

Ephedrine Injectable will be administered to you by a doctor or nurse into a vein (intravenous route).
The doctor will determine the correct dose for you and when and how the injection should be
administered.
Recommended doses:
Adults and elderly
You will be given a slow intravenous injection of 3 to 6 mg (up to a maximum of 9 mg) into a vein, repeated, if necessary, every 3-4 minutes up to a maximum total dose of 30 mg.
The total daily dose should be less than 150 mg/24 hours.
Use in children and adolescents

• Children under 12 years.

The injectable solution in pre-filled syringes containing 3 mg/ml ephedrine hydrochloride is not recommended in children under 12 years of age due to insufficient data on efficacy, safety and dosage recommendations.

• Children over 12 years. Dosage and method of administration are the same as in adults.

Patients with renal or hepatic impairment
No dose adjustments are recommended for patients with renal or hepatic disease.
If you have any doubts 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, which require immediate medical attention, are:
abnormal heart rhythm;
palpitations, high blood pressure, rapid heartbeat;
chest pain, slowing of the heartbeat, low blood pressure;
heart failure (cardiac arrest);
cerebral haemorrhage;
fluid accumulation in the lungs (pulmonary edema);
increased eye pressure (glaucoma);
difficulty urinating;

Other side effects that may occur during treatment with this medicine are listed below.
Common (may affect up to 1 in 10 people):
confusion, feeling anxious, depression;
nervousness, irritability, restlessness, weakness, insomnia, headache, sweating;
shortness of breath;
nausea, vomiting.

Not known (frequency cannot be estimated from the available data):
effects on blood coagulation;
allergic reaction;
changes in personality or in the way things are perceived or thought about, feelings of fear;
tremor, excessive production of saliva;
decreased appetite;
decrease in blood potassium levels, changes in blood glucose levels.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Injectable Ephedrine

Keep this medicine out of the sight and reach of children.
This medicine must not be administered after the expiry date stated on the carton
and on the label affixed to the syringe. The doctor or nurse will check the expiry date.
Store the blister in the outer carton to protect the medicine from light.
Unused medicine or waste material must be disposed of in accordance with
local regulations.

6. Package contents and other information

What Efedrina Iniettabile contains

• The active substance is ephedrine hydrochloride. Each ml of 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, monohydrate citric acid, sodium citrate, and water for injectable preparations; hydrochloric acid or sodium hydroxide may also be present (for pH adjustment).

Description of the appearance of Efedrina Iniettabile and contents of the pack
Efedrina Iniettabile is a clear, colourless liquid. It is supplied in a 10 ml pre-filled syringe made of polypropylene, with a polypropylene cap and a tamper-evident seal, individually packaged in a transparent blister.
Pre-filled syringes are available in packs containing 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

Responsible manufacturer for batch release:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON
France
or
LABORATOIRE AGUETTANT
Lieu-dit “Chantecaille”
07340 CHAMPAGNE
France

Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).