Ephedrini hidrohloridum Sintetica

Leaflet attached to the packaging: patient information

Ephedrini hydrochloridum Sintetica, 50 mg/ml, solution for injection

Ephedrine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor. See section 4.

Table of contents of the leaflet

• 1. What is Ephedrini hydrochloridum Sintetica and what is it used for
• 2. Important information before using Ephedrini hydrochloridum Sintetica
• 3. How to use Ephedrini hydrochloridum Sintetica
• 4. Possible side effects
• 5. How to store Ephedrini hydrochloridum Sintetica
• 6. Contents of the packaging and other information

1. What is Ephedrini hydrochloridum Sintetica and what is it used for

Ephedrini hydrochloridum Sintetica contains the active substance ephedrine hydrochloride.
Ephedrine is a sympathomimetic and stimulates the heart, but it is not a cardiac glycoside. Ephedrini hydrochloridum Sintetica is a solution for injection in an ampoule used to treat low blood pressure during general and regional anesthesia, both spinal and epidural, in adults and adolescents (over 12 years of age).
This product must be used only by or under the supervision of an anesthesiologist.

2. Important information before using Ephedrini hydrochloridum Sintetica

When not to use Ephedrini hydrochloridum Sintetica

Warnings and precautions

Before starting treatment with Ephedrini hydrochloridum Sintetica, discuss it with your doctor.
Care should be taken if the patient has:

• diabetes,
• high blood pressure (hypertension), irregular heartbeat (arrhythmia) or rapid heartbeat (tachycardia),
• enlarged prostate gland (prostatic hyperplasia),
• uncontrolled and uncontrolled excessive activity of the thyroid gland (uncontrolled hyperthyroidism),
• coronary artery disease, angina pectoris,
• weakening of the blood vessel wall leading to the formation of an aneurysm,
• narrowing and (or) blockage of blood vessels (arteriosclerosis);
• glaucoma (increased eye pressure)
• chronic anxiety and psychiatric disorders. Ephedrine should be used with caution if there have been heart diseases in the medical history.

Consult a doctor if any of the above warnings apply to the patient or have applied in the past.

Children

This medicinal product should be avoided in children under 12 years of age due to the lack of sufficient data on efficacy and safety.

Ephedrini hydrochloridum Sintetica and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well as medicines the patient plans to take, including those available without a prescription.
This is especially important in the case of the following medicines:

• methylphenidate, used to treat so-called attention deficit hyperactivity disorder (ADHD);
• indirect sympathomimetic stimulants, such as phenylpropanolamine or pseudoephedrine (medicines used for rhinitis) and phenylephrine (a medicine used to treat low blood pressure);
• alpha-adrenolytics (e.g. phentolamine) and beta-adrenolytics used to control blood pressure;
• medicines used to treat depression;
• inhalation anesthetics, such as halothane;
• clonidine, guanethidine and related medicines used to treat hypertension;
• sibutramine, a medicine used to suppress appetite;
• ergot alkaloids, medicines used as vasoconstrictors or due to their dopaminergic effect (increasing dopamine-dependent brain activity);
• linezolid, used to treat infections;
• reserpine and methyldopa and related medicines used to treat hypertension.
• medicines used to treat asthma, such as theophylline;
• medicines that change the pH of urine;
• corticosteroids, medicines used to treat inflammatory and allergic reactions;
• atropine, a medicine used to treat certain types of chemical poisoning and pesticide poisoning, as well as certain types of bradycardia;
• antiepileptic drugs;
• oxytocin, a medicine used during childbirth;
• aminophylline or other xanthines, medicines used to treat respiratory disorders;
• cardiac glycosides used to treat heart failure.

Pregnancy, breastfeeding and fertility

Pregnancy
This medicine should be used during pregnancy only if necessary.
The patient should consult a doctor before using any medicine.
Breastfeeding
Although there is a lack of detailed data in this regard, it is assumed that ephedrine passes through the placenta and into breast milk. Breastfeeding should be discontinued for two days after administration.
The patient should consult a doctor before using any medicine.

Driving and using machines

Not applicable.

3. How to use Ephedrini hydrochloridum Sintetica

Method of administration
In the form of intravenous injection.
Dosage:
Ephedrine should be administered in the smallest effective dose for the shortest possible time.
Adults and adolescents:Slow intravenous injection of 5 mg (up to 10 mg), if necessary, repeated every 3-4 minutes. The total dose administered within 24 hours must not exceed 150 mg.
Children: The safety and efficacy of ephedrine in children under 12 years of age have not been established.
Data are not available.
Elderly patients:
As for adults, starting with 5 ml in a bolus. For very elderly patients, a higher dose may be necessary.

Using a higher dose of Ephedrini hydrochloridum Sintetica than recommended

In case of overdose, the following are observed: migraines, nausea, vomiting, high blood pressure (hypertension), rapid heartbeat (tachycardia), fever, paranoid psychosis, hallucinations, ventricular and supraventricular arrhythmia, respiratory depression, seizures, and coma.
In case of any further doubts about the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Ephedrini hydrochloridum Sintetica, the following side effects may occur:

Very common (may affect more than 1 in 10 people):

• -episodes of glaucoma with closed-angle glaucoma in patients with anatomical predispositions

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

• -insomnia, nervousness

Uncommon (may affect up to 1 in 100 people):

• tremors, sweating
• rapid heartbeat (tachycardia), feeling of heartbeat (palpitations)
• nausea, vomiting
• inability to urinate (acute urinary retention)
• migraine

Rare (may affect up to 1 in 1000 people):

• anxiety
• heart rhythm disorders, high blood pressure (hypertension), chest pain (precordial pain)

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

• changes in blood coagulation parameters (primary hemostasis)
• allergy (hypersensitivity reaction)
• irritability
• confusion, depression
• muscle weakness
• skin rash

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor 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 Ephedrini hydrochloridum Sintetica

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box and ampoule after: EXP.
The expiry date refers to the last day of the month.
Do not freeze.
This medicinal product does not require any special storage conditions.
The product does not contain preservatives and should be used immediately after opening.
Do not use this medicine if you notice any particles or sediment in the ampoule.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ephedrini hydrochloridum Sintetica contains

The active substance is ephedrine hydrochloride.
Each 1 ml ampoule contains 50 mg of ephedrine hydrochloride.
The other ingredients are sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.

What Ephedrini hydrochloridum Sintetica looks like and what the pack contains

This medicinal product is a solution for injection. The solution is clear, colorless, and free of visible particles.
Ephedrini hydrochloridum Sintetica 50 mg/ml solution for injection is supplied in 2 ml colorless glass type I ampoules with a break point (OPC), in a cardboard box.
The cardboard box contains 10 ampoules of 1 ml solution for injection.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany

Manufacturer

Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

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Qualitative and quantitative composition

1 ml of solution for injection contains 50 mg of ephedrine hydrochloride.
1 ampoule of 1 ml solution contains 50 mg of ephedrine hydrochloride.

Indications

Treatment of hypotension caused by spinal or epidural anesthesia and during general anesthesia in adults and adolescents (over 12 years of age).

Dosage and method of administration

Ephedrine should be administered in the smallest effective dose for the shortest possible time.
Adults and adolescents:Slow intravenous injection of 5 mg (up to 10 mg), if necessary, repeated every 3-4 minutes. The total dose administered within 24 hours must not exceed 150 mg.
Children: The safety and efficacy of ephedrine in children under 12 years of age have not been established.
Data are not available.

Elderly patients:
As for adults, starting with 5 ml in a bolus. For very elderly patients, a higher dose may be necessary.
Method of administration
Ephedrine must be used only by an anesthesiologist or under their supervision by intravenous injection.

Overdose

Symptoms
In case of overdose, the following are observed: migraines, nausea, vomiting, hypertension, tachycardia, fever, paranoid psychosis, hallucinations, ventricular and supraventricular arrhythmia, respiratory depression, seizures, and coma.
Treatment
To treat overdose and control central nervous system stimulation and seizures, diazepam can be administered in doses of 0.1 to 0.2 mg/kg. A dose of 10 to 20 mg can be administered as a single slow intravenous injection.
To treat agitation, hallucinations, and hypertension, chlorpromazine should be administered.
To treat severe hypertension, phentolamine or another alpha-adrenergic receptor antagonist can be administered.
To treat hypertension or severe tachyarrhythmia, the use of a beta-adrenolytic, such as propranolol, may be beneficial.

Incompatibilities

Do not mix this medicinal product with other medicinal products, as compatibility studies have not been performed.

Special precautions for disposal and preparation of the medicinal product for administration

Instructions for use:
The ampoule is intended for single use only.
Discard the ampoule after use. DO NOT REUSE.
The contents of an unopened and undamaged ampoule are sterile and should not be opened before use.
The product should be visually inspected before administration to detect any particles or discoloration.
Only a clear, colorless solution without particles or sediment should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

To obtain full information on the use of the medicine, consult the

Summary of Product Characteristics.