EPHEDRINE HYDROCHLORIDE MONICO

Package leaflet: Information for the user

EFEDRINA CLORIDRATO MONICO 25 mg/1 ml injectable solution

Ephedrine hydrochloride
Generic medicine
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EFEDRINA CLORIDRATO MONICO is and what it is used for

EFEDRINA CLORIDRATO MONICO contains the active substance ephedrine hydrochloride, which belongs to a group of medicines called nasal decongestants.
EFEDRINA CLORIDRATO MONICO is used for:

• treating sudden and severe breathing difficulty due to narrowing of the airways (acute bronchospasm);
• treating and preventing low blood pressure that may occur during anaesthesia for various types of surgical procedures (spinal, epidural or intrathecal anaesthesia).

2. What you need to know before using EFEDRINA CLORIDRATO MONICO

Do not use EFEDRINA CLORIDRATO MONICO

• if you are allergic to ephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to certain medicines (sympathomimetic amines) used to treat nasal congestion or low blood pressure;
• if you have high eye pressure (closed-angle glaucoma);
• if you suffer from mental disorders (psychosis);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before being administered EFEDRINA CLORIDRATO MONICO.
This medicine should be administered with great caution in the following cases:

• if you experience chest pain due to heart problems (angina pectoris) or suffer from other chronic heart diseases. If you develop these symptoms during treatment, inform your doctor immediately;
• if you have an enlarged prostate (prostatic hypertrophy);
• if you are elderly;
• if you are pregnant and have high blood pressure (above 130/80);
• if you suffer from diabetes;
• if you have high blood pressure;
• if you have severe heart diseases (myocardial ischemic diseases, arrhythmias, or severe heart failure) or circulatory problems (cardiovascular disorders);
• if you suffer from thyroid problems (thyrotoxicosis).

For individuals engaged in sports, the use of this medicine without genuine therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and EFEDRINA CLORIDRATO MONICO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
This medicine must not be administered concomitantly with certain medicines similar to adrenaline used to treat nasal congestion, respiratory problems, or low blood pressure (sympathomimetic agents).
This medicine should be used with caution when taken together with the following medicines:

• alpha-blocking agents used to lower blood pressure, as they may reduce the effect of ephedrine, and beta-blockers (e.g., propranolol), as they may diminish ephedrine's effects on the heart;
• medicines used during anesthesia such as cyclopropane and halothane, as they may cause disturbances in heart rhythm (arrhythmias);
• guanethidine, a medicine used to treat high blood pressure, because ephedrine may reduce its effectiveness;
• medicines for depression such as MAO inhibitors (e.g., furazolidone, isocarboxazid, iproniazid, pargyline, phenelzine, selegiline), because they may cause an increase in blood pressure;
• procarbazine, a medicine used in cancer treatment, because it may cause an increase in blood pressure;
• sodium bicarbonate, because it reduces ephedrine elimination and may cause increased blood pressure (hypertension) and disturbances in heart rhythm (tachycardia);
• aminophylline-theophylline ethylenediamine, used for respiratory problems, because ephedrine may increase side effects (nausea, vomiting, insomnia);
• medicines used to treat irregular heartbeat (cardiac glycosides), because they may enhance the effects of ephedrine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered.
This medicine must not be administered during pregnancy unless strictly necessary, as it may cause problems in the fetus (fetal hyperactivity, irritability, and tachycardia).
Use this medicine with caution if you are breastfeeding, as it is unknown whether ephedrine passes into breast milk.

Driving and using machines
Avoid driving or operating machinery if, after taking this medicine, you experience symptoms such as nervousness, anxiety, and tremors, and, at high doses, paranoia, hallucinations, and depression.

3. How to use EFEDRINA CLORIDRATO MONICO

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition. This medicine is administered by
injection into the muscle (intramuscular), under the skin (subcutaneous), or into the vein
(intravenous).
Treatment of breathing problems (bronchospasm): the recommended dose in adults and adolescents is
12.5 to 25 mg administered intramuscularly, subcutaneously, or intravenously.
Treatment of low blood pressure caused by spinal, epidural, or intrathecal anaesthesia: the
recommended dose in adults and adolescents is 25 to 50 mg administered subcutaneously or intramuscularly, or
intravenously when a rapid effect is required.
Use in children (up to 12 years of age)
Treatment of breathing problems (bronchospasm): the recommended dose is 750 micrograms per
kg of body weight or 25 mg per m² of body surface area, administered subcutaneously or intravenously,
depending on the patient's response.
Treatment of low blood pressure caused by spinal, epidural, or intrathecal anaesthesia: the
recommended dose is 0.2–0.3 mg per kg of body weight, repeated every 4–6 hours depending on the patient's
response.
If you use more EFEDRINA CLORIDRATO MONICO than you should
If you accidentally use too much of this medicine, contact your doctor immediately or go to the nearest
hospital.
Symptoms of overdose may include: facial flushing, sweating, vomiting, changes in heart rate (tachycardia,
tachyarrhythmias), and increased blood pressure (hypertension). Treatment includes administration of an
antidote (chlorpromazine) by intramuscular or intravenous injection, and forced elimination of the medicine
from the body through the urine.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Inform your doctor immediately if you experience chest pain during treatment with this medicine, as it may be caused by heart problems (angina); however, do not stop treatment unless advised by your doctor.

The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• heart problems, such as changes in heartbeat rate (palpitations, tachycardia, ventricular arrhythmias);
• increased blood pressure;
• chest pain (precordial pain) and, in severe cases, heart attack;
• stomach disturbances, nausea, vomiting;
• loss of appetite (anorexia);
• anxiety, fear, agitation, excitement, restlessness, weakness, irritability, insomnia, tremors, paranoia, hallucinations;
• difficulty urinating (urinary retention);
• breathing difficulties, dryness of the nasal and pharyngeal mucosa;
• excessive sweating.

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EFEDRINA CLORIDRATO MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EFEDRINA CLORIDRATO MONICO contains

• The active substance is ephedrine hydrochloride. Each vial contains 25 mg of ephedrine hydrochloride.
• The other component is water for injections.

Description of the appearance of EFEDRINA CLORIDRATO MONICO and package contents
Pack containing 5 vials of 1 ml of injectable solution.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE - Italy.