EFEDRINE Fresenius Kabi 3 mg/ml Injectable Solution

Introduction

Patient Information: Summary of Product Characteristics

Ephedrine Fresenius Kabi 3 mg/ml Solution for Injection

ephedrine hydrochloride

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.
• If you get 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 pack

1. What Ephedrine Fresenius Kabi is and what it is used for
2. What you need to know before you use Ephedrine Fresenius Kabi
3. How to use Ephedrine Fresenius Kabi
4. Possible side effects
5. Storage of Ephedrine Fresenius Kabi
6. Contents of the pack and other information

1. What Ephedrine Fresenius Kabi is and what it is used for

Ephedrine Fresenius Kabi contains the active substance ephedrine hydrochloride.

Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic medicines affect the part of the nervous system that works automatically.

This medicine is a solution for injection in an ampoule used for the treatment of arterial hypotension during general and local/regional anaesthesia, either spinal or epidural in adults and children (over 12 years).

This product should only be used by or under the supervision of an anaesthetist.

2. What you need to know before you use Ephedrine Fresenius Kabi

Your doctor will not give you Ephedrine Fresenius Kabi if:

• You are allergic to ephedrine or any of the other ingredients of this medicine (listed in section 6).
• You are taking other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used as nasal decongestants) or methylphenidate (medicine used to treat “attention deficit hyperactivity disorder (ADHD)”).
• You are taking an alpha-adrenergic agent (medicine used to treat arterial hypotension).
• You are taking or have taken in the last 14 days a non-selective monoamine oxidase inhibitor (medicine used to treat depression).

Warnings and precautions

Tell your doctor before you start using this medicine if:

• You have diabetes.
• You have any heart disease or other cardiac condition, including angina.
• You have weakness in the wall of the blood vessels that causes a bulge (aneurysm).
• You have high blood pressure.
• You have narrowing and/or blockage of the blood vessels (occlusive vascular diseases).
• You have an overactive thyroid gland (hyperthyroidism).
• You know or suspect that you may have glaucoma (increased eye pressure) or an enlarged prostate gland (prostatic hyperplasia).
• You are about to undergo surgery that requires anaesthesia.
• You are currently taking or have taken in the last 14 days any monoamine oxidase inhibitor to treat depression.

This medicine contains an active substance that may give a positive reaction in anti-doping tests.

Other medicines and Ephedrine Fresenius Kabi

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.

This information is especially important with the following medicines:

• methylphenidate, used to treat “attention deficit hyperactivity disorder (ADHD)”.
• other vasoconstrictors such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants), phenylephrine (medicine used to treat hypotension).
• alpha and beta-adrenergic blockers (oral and/or nasal use) used to treat hypotensionor nasal congestion, among others.
• medicines used to treat depression.
• ergot alkaloids, a type of medicine used to treat migraines.
• linezolid, used to treat infections.
• guanethidine and related medicines, used to treat high blood pressure.
• sibutramine, a medicine used as an appetite suppressant.
• inhalation anaesthetics, such as halothane.
• medicines used to treat asthma, such as theophylline.
• corticosteroids, a type of medicine used to relieve inflammation in 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 breast-feeding

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

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

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

Ephedrine Fresenius Kabi contains sodium

This medicine contains 3.21 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 0.16% of the maximum recommended daily intake of sodium for an adult.

This medicine contains 32.1 mg of sodium (main component of cooking/table salt) in each 10 ml ampoule. This is equivalent to 1.6% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ephedrine Fresenius Kabi

Your doctor or nurse will give you this medicine by injection into a vein (intravenously). Your doctor will decide the correct dose for you and when and how the injection should be given.

The recommended dose is:

Adults and elderly for 3 mg/ml

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/24 hours.

Use in children and adolescents

• Children under 12 years

This medicine is not recommended for use in children under 12 years of age due to insufficient data on efficacy, safety, and dosage recommendations.

• Children over 12 years

The posology 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.

If you have any other questions on the use of this medicine, ask 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:

• abnormal heart rhythm;
• palpitations (feeling the heartbeat), high blood pressure, rapid heartbeat;
• heart pain, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• brain haemorrhage;
• fluid accumulation between the lungs (pulmonary oedema);
• 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;
• allergic reaction;
• changes in personality or the way you feel or think, fear;
• tremor, excessive saliva production;
• decreased appetite;
• reduction of potassium levels in the blood, 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 Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ephedrine Fresenius Kabi

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 label after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

After opening the ampoule, the product should be used immediately. However, the undiluted solution can be stored in a syringe for 72 hours at 25 °C and for 72 hours at 2 to 8 °C.

Do not use this medicine if you notice particles in the solution.

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 pack and other information

Composition of Ephedrine Fresenius Kabi

The active substance is ephedrine hydrochloride.

Each ml of solution for injection contains 3 mg of ephedrine hydrochloride.

Each 10 ml glass ampoule contains 30 mg of ephedrine hydrochloride.

• The other ingredients (excipients) are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Appearance and pack contents

Ephedrine Fresenius Kabi is a clear, colourless to pale yellow solution for injection.

Ephedrine Fresenius Kabi 3 mg/ml solution for injection is available in 10 ml glass ampoules. Pack sizes of 5 and 10 ampoules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Fresenius Kabi España, S.A.U.

C/ Marina 16-18

08005 – Barcelona

Spain

Manufacturer:

Labesfal Laboratorios Almiro S.A.

Zona Industrial Do Lagedo 3465-157 Santiago de Besteiros

Portugal

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Therapeutic indication

Treatment of hypotension due to spinal, epidural, and general anaesthesia.

Posology and method of administration

Posology 3 mg/ml

Adults

Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as necessary every 3-4 minutes up to a maximum of 30 mg. Lack of efficacy after 30 mg should lead to reconsideration of the choice of therapeutic agent. The total dose administered during 24 hours should not exceed 150 mg.

Paediatric population

In general, the use of Ephedrine Fresenius Kabi is not recommended in children due to insufficient data on efficacy, safety, and dosage recommendations.

• Children under 12 years

The safety and efficacy of ephedrine in paediatric patients under 12 years have not been established. No data are available.

• Children over 12 years

The posology and method of administration are the same as for adults.

Patients with renal or hepatic insufficiency

No dose adjustment is recommended for patients with renal or hepatic insufficiency.

Elderly patients

Same as for adults.

Method of administration

Ephedrine should only be used by or under the supervision of an anaesthetist as an intravenous injection.

For intravenous use.

Overdose

In case of overdose, nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, convulsions, and coma are observed.

The lethal dose in humans is approximately 2 g, corresponding to blood concentrations of approximately 3.5 to 20 mg/l.

Treatment

Treatment of ephedrine overdose with this product may require intensive supportive treatment. A slow intravenous injection of 50 to 200 mg of labetalol with electrocardiographic monitoring may be administered to treat supraventricular tachycardia. Marked hypokalaemia (<2.8 mmol/l) due to potassium compartment shift predisposes to cardiac arrhythmias and may be corrected by potassium chloride infusion in addition to propranolol and correcting respiratory alkalosis, when present.

A benzodiazepine and/or a neuroleptic agent may be required to control the central nervous system stimulant effects.

For severe hypertension, parenteral anti-hypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine. The choice of anti-hypertensive agent depends on availability, concomitant conditions, and the patient's clinical status.

Preparation

For single use.

Ephedrine Fresenius Kabi is compatible with:

• sodium chloride 9 mg/ml (0.9% w/v)
• glucose 50 mg/ml (5% w/v) infusion
• Ringer's lactate infusion

Shelf life

Unopened: 30 months

Shelf life after opening the ampoule:

The product should be used immediately

Shelf life of the undiluted solution when stored in a syringe:

Chemical and physical stability has been demonstrated for 72 hours at 25 °C and for 72 hours between 2 and 8 °C.