Ephedrine hydrochloride aguettant

Patient Information Leaflet

Ephedrinum Hydrochloricum Aguettant, 3 mg/ml, solution for injection in ampoule-syringe
Ephedrine hydrochloride
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Ephedrinum Hydrochloricum Aguettant is and what it is used for
2. Important information before using Ephedrinum Hydrochloricum Aguettant
3. How to use Ephedrinum Hydrochloricum Aguettant
4. Possible side effects
5. How to store Ephedrinum Hydrochloricum Aguettant
6. Contents of the pack and other information

1. What Ephedrinum Hydrochloricum Aguettant is and what it is used for

This medicine is used to manage low blood pressure caused by anaesthesia.

2. Important information before using Ephedrinum hydrochloricum

Aguettant
When not to use Ephedrinum hydrochloricum Aguettant:

• if the patient is allergic to ephedrine hydrochloride or any of the other components of this medicine (listed in section 6);
• if the patient is taking another sympathomimetic agent, such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used in the treatment of nasal congestion) or methylphenidate (a medicine used in the treatment of attention deficit hyperactivity disorder (ADHD));
• if the patient is taking an alpha-sympathomimetic medicine (medicines used in the treatment of low blood pressure);
• if the patient is taking or has taken within the last 14 days non-selective monoamine oxidase inhibitors (medicines used in the treatment of depression).

Warnings and precautions
Before using Ephedrinum hydrochloricum Aguettant, discuss with your doctor:

• if the patient has diabetes;
• if the patient has heart disease or any other heart condition, including angina pectoris;
• if the patient has weakening of the blood vessel wall leading to aneurysm formation;
• if the patient has high blood pressure;
• if the patient has narrowing and/or blockage of blood vessels (peripheral vascular disease);
• if the patient has overactivity (hyperthyroidism) of the thyroid gland;
• if the patient has or is suspected of having glaucoma (increased pressure in the eye) or benign prostatic hyperplasia (enlarged prostate);
• if the patient is due to undergo surgery requiring anaesthetic;
• if the patient is currently taking or has taken within the last 14 days any monoamine oxidase inhibitors used in the treatment of depression.

Ephedrinum hydrochloricum Aguettant and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important for the following medicines:

• methylphenidate, used in the treatment of attention deficit hyperactivity disorder (ADHD);
• indirect-acting sympathomimetic agents such as phenylpropanolamine or pseudoephedrine (medicines used in nasal congestion) and phenylephrine (a medicine used in the treatment of low blood pressure);
• direct-acting alpha-adrenergic receptor agonists (administered orally and/or intranasally), used among others in the treatment of low blood pressure and nasal congestion;
• medicines used in the treatment of depression;
• ergot alkaloids, a group of medicines used as vasoconstrictors or due to their dopaminergic activity (increasing dopamine-dependent brain activity);
• linezolid, used in the treatment of infections;
• guanethidine and related medicines, used in the treatment of high blood pressure;
• sibutramine, a medicine used to suppress appetite;
• inhaled anaesthetics, such as halothane;
• medicines used in the treatment of asthma, such as theophylline;
• corticosteroids, a group of medicines used to reduce swelling caused by various conditions;
• antiepileptic medicines;
• doxapram, a medicine used in the treatment of respiratory disorders;
• oxytocin, a medicine used during childbirth;
• reserpine and methyldopa and related medicines, used in the treatment of high blood pressure.

Pregnancy and breastfeeding
Ephedrine should be avoided during pregnancy or used with caution and only when necessary. Depending on the patient's condition and according to medical advice, breastfeeding may need to be interrupted for several days after administration of ephedrine. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor, pharmacist or nurse before using this medicine.

Laboratory tests
This medicine contains an active substance which may cause positive results in doping tests.
Ephedrinum hydrochloricum Aguettant contains sodium
This medicine contains 33.9 mg of sodium (main component of table salt) in each 10 ml pre-filled syringe. This corresponds to 1.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ephedrinum Hydrochloricum Aguettant

Ephedrinum Hydrochloricum Aguettant will be administered by a doctor or nurse as an intravenous injection.
The doctor will determine the appropriate dose for the patient, as well as the timing and method of injection.
Recommended doses:
Adults and elderly patients
The patient will receive a slow intravenous injection of 3 to 6 mg (up to a maximum of 9 mg), which may be repeated as needed every 3–4 minutes, up to a maximum total dose of 30 mg.
The total daily dose must be less than 150 mg/24 hours.
Use in children and adolescents

• Children under 12 years of age: Ephedrinum Hydrochloricum Aguettant 3 mg/ml solution for injection in pre-filled syringe is not recommended for use in children under 12 years of age due to insufficient data on efficacy, safety, and recommended dosage.
• Children from 12 years of age: Dosage and route of administration are the same as for adults.

Patients with renal or hepatic impairment:
No dose adjustment is required in patients with renal or hepatic impairment.
If you have any further questions concerning 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 requiring immediate medical attention include:

• irregular heartbeat;
• palpitations, high blood pressure, rapid heartbeat;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cessation of heart activity);
• intracranial haemorrhage;
• fluid accumulation in the lungs (pulmonary oedema);
• increased pressure in the eye (glaucoma);
• difficulty passing urine.

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, sleep problems, headache, sweating;
• shortness of breath;
• nausea, vomiting.

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

• blood clotting disorders;
• allergic reactions;
• changes in personality or thinking and emotional state, anxiety;
• tremor, excessive salivation;
• decreased appetite;
• decreased blood potassium levels, changes in blood glucose levels.

Reporting of side effects

If any side effects occur in the patient, including any side effects not listed in this leaflet, inform a doctor, pharmacist or nurse.

Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ephedrinum Hydrochloricum Aguettant

Keep the medicine out of the sight and reach of children.
The patient must not receive this medicine after the expiry date stated on the carton and on the syringe label.
The doctor or nurse will check the expiry date.
Store the blister containing the ampoule-syringe in the cardboard carton to protect it from light.
Any unused product or waste material must be disposed of in accordance with local regulations.

6. Contents of the package and other information

What Ephedrinum Hydrochloricum Aguettant contains

• The active substance is ephedrine hydrochloride. Each millilitre of injection solution contains 3 mg of ephedrine hydrochloride. Each 10 ml pre-filled syringe contains 30 mg of ephedrine hydrochloride.
• The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate and water for injections. The medicine may also contain hydrochloric acid or sodium hydroxide (for pH adjustment).

What Ephedrinum Hydrochloricum Aguettant looks like and contents of the pack
Ephedrinum Hydrochloricum Aguettant is a clear, colourless liquid. The medicine is supplied in a 10 ml polypropylene pre-filled syringe with a polypropylene plug and a tamper-evident seal, individually packed in a transparent blister.
Pre-filled syringes are available in cardboard boxes containing 1, 5, 10, 12 or 20 units. Not all pack sizes may be marketed.

Marketing Authorisation Holder
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France
or
LABORATOIRE AGUETTANT
Lieu-dit “Chantecaille”
07340 CHAMPAGNE
France

For further information about this medicine, contact the marketing authorisation holder's representative:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.