Ebrantil 25

Package Leaflet: Information for the Patient

Ebrantil 25, 5 mg/ml, Solution for Injection

Urapidilum

Read the package 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 or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Ebrantil 25 and what is it used for
• 2. Important information before using Ebrantil 25
• 3. How to use Ebrantil 25
• 4. Possible side effects
• 5. How to store Ebrantil 25
• 6. Contents of the pack and other information

1. What is Ebrantil 25 and what is it used for

Urapidil, the active substance of Ebrantil 25, leads to a simultaneous decrease in systolic and diastolic blood pressure by reducing peripheral resistance. The heart rate usually remains unchanged.
The cardiac output does not change under the influence of Ebrantil 25, but may increase if it was decreased as a result of increased afterload.
Ebrantil 25 is used:

• in emergency situations in the course of hypertension (e.g. hypertensive crisis), in severe and very severe hypertension, in resistant hypertension;
• in controlled blood pressure reduction in case of increased blood pressure during and/or after surgery.

2. Important information before using Ebrantil 25

When not to use Ebrantil 25

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has aortic stenosis or arteriovenous shunt (except for non-functional hemodynamic shunt for dialysis).

Warnings and precautions

Particular caution should be exercised when using Ebrantil 25:

• in patients with heart failure due to mechanical damage (e.g. aortic or mitral stenosis), pulmonary embolism, or impaired cardiac function for extracardiac reasons;
• in children, as there is no experience with the use of the medicine in this patient group;
• in patients with liver function disorders (a dose reduction of Ebrantil 25 may be necessary);
• in patients with moderate or severe kidney function disorders (a dose reduction of Ebrantil 25 may be necessary);
• in elderly patients. Due to the changed sensitivity of elderly patients, blood pressure-lowering drugs should be used initially in smaller doses;
• in patients treated simultaneously with cimetidine (see section Ebrantil 25 and other medicines).

If another blood pressure-lowering medicine was administered earlier, before administering Ebrantil 25, one should wait for the effect of the administered medicine on blood pressure to become apparent, and then adjust the dosage of Ebrantil 25 accordingly.
An excessively rapid decrease in blood pressure may lead to a slowing or cessation of heart activity.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Ebrantil 25 should not be used during pregnancy, unless the potential benefits to the mother outweigh the potential risks to the fetus.
During the use of Ebrantil 25, breastfeeding should be avoided.

Driving and using machines

Due to individual reactions to the medicine, the ability to drive vehicles and operate machines may be impaired. This may occur especially at the beginning of treatment, when increasing the dose of the medicine, changing the medicine to another one, and when consuming alcohol during the use of the medicine.

Ebrantil 25 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effect of the medicine may be enhanced by:

• concomitant use of alpha-adrenergic receptor antagonists (e.g. clonidine), vasodilators, and other blood pressure-lowering medicines;
• dehydration caused by e.g. vomiting or diarrhea;
• alcohol.

Concomitant use of cimetidine (an anti-ulcer medicine) may increase the concentration of urapidil in the serum.
Due to the lack of sufficient data on the interaction between Ebrantil 25 and angiotensin-converting enzyme inhibitors (medicines used in hypertension and heart diseases), these medicines should not be used simultaneously.
The medicine contains 500 mg of propylene glycol in 5 ml of solution for injection (1 ampoule).
Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Propylene glycol contained in this medicine may cause symptoms similar to those after alcohol consumption and increase the likelihood of side effects.
The medicine should not be used in children under 5 years of age.
The medicine should only be used on a doctor's prescription. The doctor may decide to perform additional tests on the patient taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of solution for injection (1 ampoule), which means the medicine is considered "sodium-free".

3. How to use Ebrantil 25

Emergency situations in the course of hypertension (e.g. hypertensive crisis), severe and very severe hypertension, resistant hypertension.

• 1) Intravenous injectionsof 10 to 50 mg of urapidil should be administered slowly intravenously with simultaneous blood pressure monitoring. A decrease in blood pressure usually occurs within 5 minutes after administration of the medicine. Depending on the reaction, the administration of Ebrantil 25 can be repeated.
• 2) Intravenous drip infusion or continuous infusion using an infusion pump
• To maintain the blood pressure level achieved after injection, an intravenous drip infusion of the solution should be prepared as follows: 250 mg of urapidil (10 ampoules of Ebrantil 25) should be added to 500 ml of infusion solution, e.g. 0.9% sodium chloride solution, 5% or 10% glucose solution.
• If the maintenance dose is administered using an infusion pump, 100 mg of urapidil (4 ampoules of Ebrantil 25) should be diluted in the infusion pump syringe with one of the above infusion solutions to a volume of 50 ml.

The maximum concentration of urapidil in the infusion solution should not exceed 4 mg/ml.
Administration rate:
The infusion rate depends on the individual patient's reaction to the medicine.
The recommended initial maximum administration rate is 2 mg/min.
Maintenance dose:
On average, 9 mg/h: this applies to 250 mg of urapidil added to 500 ml of infusion solution (1 mg = 44 drops = 2.2 ml).

Controlled blood pressure reduction in case of increased blood pressure during and/or after surgery.

Maintenance of blood pressure at the intended level is achieved by using a continuous intravenous drip infusion or infusion with an infusion pump after injection.

Dosing Schedule

General Instructions

• During intravenous administration of Ebrantil 25, both injections and infusions, the patient should be in a lying position.
• Single or repeated injections and infusions are possible. Injections can be followed by infusion.
• It is possible to use oral blood pressure-lowering medicine during the extragastric use of Ebrantil 25.
• Due to toxicological safety, Ebrantil 25 can be administered extragastrically for a period of up to 7 days. This period should not be extended. Extragastric treatment can be repeated in case of renewed increased blood pressure.

Using a higher dose of Ebrantil 25 than recommended

Overdose symptoms are:

• cardiovascular symptoms: dizziness, orthostatic decrease in blood pressure, and fainting;
• central nervous system symptoms: fatigue and decreased reaction speed.

In case of overdose, the doctor should be informed immediately.
Excessive decrease in blood pressure can be counteracted by placing the patient with their legs elevated and proper hydration of the body.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects listed below are the result of a sudden decrease in blood pressure. As shown by the experience to date, side effects disappear after a few minutes, even during intravenous drip infusion. Depending on their severity, it may be necessary to consider discontinuing treatment.
The following side effects may occur during the use of Ebrantil 25:

Common (more than 1 in 10 patients):

• nausea;
• headache, dizziness.

Uncommon (more than 1 in 100 patients):

• palpitations, accelerated heart rate (tachycardia), slowed heart rate (bradycardia), feeling of pressure or pain in the chest (symptoms similar to angina pectoris);
• vomiting;
• fatigue;
• irregular heartbeat;
• sudden excessive sweating;
• decrease in blood pressure when changing body position, e.g. when getting up from a lying position (orthostatic hypotension).

Rare (more than 1 in 1000 patients):

• prolonged erection (priapism);
• nasal congestion;
• allergic reactions, such as itching, redness, rash.

Very rare (less than 1 in 1000 patients):

• decrease in platelet count;
• restlessness.

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

• angioedema (a life-threatening condition characterized by limited, painless swelling, most often affecting the face, limbs, and joints, without itching), urticaria.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or nurse should be informed. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ebrantil 25

Do not store below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.

6. Contents of the pack and other information

What Ebrantil 25 contains

• The active substance of the medicine is urapidil (Urapidilum). One ampoule with 5 ml of solution for injection contains 27.35 mg of urapidil hydrochloride (equivalent to 25 mg of urapidil). 1 ml of solution for injection contains 5 mg of urapidil .
• The other ingredients are: propylene glycol, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections.

What Ebrantil 25 looks like and contents of the pack

Clear, colorless solution for injection.
The pack contains 5 ampoules of 5 ml each.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Takeda Austria GmbH
St. Peter Strasse 25
A-4020 Linz
Austria

Date of last revision of the leaflet: 06/2021

Information intended for healthcare professionals only:
Ebrantil 25 has an acidic reaction and should not be mixed with alkaline solutions for injection and infusion solutions, as this may cause clouding and precipitation.
The prepared infusion solution is chemically and physically stable for 50 hours at a temperature of 15-25°C. To maintain microbiological purity, the solution should be used immediately after preparation.
If the infusion solution is not administered immediately after preparation, the medical staff is responsible for the time and conditions of storage and administration of the infusion solution.
The infusion solution can be used within 50 hours of preparation, provided it has been prepared and stored in controlled and validated aseptic conditions.