Tahiben

Leaflet accompanying the packaging: patient information

Tachyben, 25 mg, solution for injection

Tachyben, 50 mg, solution for injection

Urapidyl

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor. See section 4.

Table of contents of the leaflet:

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

1. What is Tachyben and what is it used for

Tachyben contains the active substance urapidil.
Tachyben belongs to a group of medicines called alpha blockers. These medicines work in blood vessels
(i.e., arteries and veins). They cause a decrease in blood pressure by reducing the tension of blood vessel walls.
Tachyben is used to treat sudden, severe increases in blood pressure:

• in situations of sudden increase in blood pressure threatening to damage sensitive organs;
• during and after surgical procedures.

2. Important information before using Tachyben

When not to use Tachyben:

• if the patient is allergic to urapidil or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a heart defect called aortic stenosis or vascular abnormalities called shunt (except for arteriovenous shunt in dialyzed patients).

Warnings and precautions

Before starting treatment with Tachyben, the doctor will check:

• if the patient has had diarrhea or vomiting (or other conditions that reduce the amount of fluids in the body);
• if there is a decrease in sodium levels in the blood.

Tachyben and other medicines

Please tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, as they may interact with Tachyben, changing its effectiveness or increasing the risk of side effects:

• Alpha receptor blockers used to treat urinary problems caused by prostate disease
• Any blood pressure-lowering medicines
• Baclofen (used to treat muscle spasms)
• Cimetidine (used to inhibit stomach acid production)
• Imipramine and neuroleptic medicines (used to treat depression)
• Corticosteroids (anti-inflammatory medicines, sometimes called steroids)

Tachyben and alcohol

Caution should be exercised when treating with Tachyben and drinking alcohol. This may enhance the effects of urapidil.

Pregnancy, breastfeeding, and fertility

Tachyben is not recommended for women of childbearing age who do not use effective contraception.
There is insufficient data to assess the safety of urapidil in pregnant women.
Tachyben should not be used during pregnancy, unless the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
It is not known whether Tachyben passes into breast milk. For safety reasons, breastfeeding is not recommended during treatment with Tachyben.
The effect of Tachyben on fertility is not known.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, please consult your doctor before using this medicine.

Driving and using machines

Tachyben may affect your ability to drive and use machines, especially:

• when starting treatment or changing the dose,
• when consuming alcohol and alcoholic beverages.

If you feel unwell, do not drive or operate machinery until the symptoms have resolved.

Tachyben 25 mg contains sodium

Tachyben 25 mg, solution for injection contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

Tachyben 25 mg contains propylene glycol

Tachyben, 25 mg, solution for injection contains 500 mg of propylene glycol per ampoule, which 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 the advice of a doctor.
The doctor may decide to perform additional tests on the patient taking this medicine.

Tachyben 50 mg contains sodium

Tachyben, 50 mg, solution for injection contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

Tachyben 50 mg contains propylene glycol

Tachyben, 50 mg, solution for injection contains 1000 mg of propylene glycol per ampoule, which 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 the advice of a doctor.
The doctor may decide to perform additional tests on the patient taking this medicine.

3. How to use Tachyben

Tachyben will be prescribed by your doctor and administered by your doctor or qualified medical staff.

Dosage

Your doctor will decide what dose of Tachyben is appropriate for you, depending on your condition.

Special patient groups

• Tachyben is not recommended for children and adolescents under 18 years of age due to lack of data on efficacy and safety.
• In elderly patients (over 65 years), a dose reduction may be necessary.
• If the patient has liver disease (severe liver failure), a dose reduction may be necessary.
• If the patient has kidney disease (severe renal failure), it may be necessary to perform tests to assess blood circulation.
• If the patient has heart failure due to mechanical disorders, caution should be exercised.

Method of administration

Tachyben is administered intravenously.

Duration of therapy

The duration of treatment with Tachyben should not exceed 7 days.

Use of a higher than recommended dose of Tachyben

The most likely event in case of overdose is a sudden drop in blood pressure, which, if the patient is standing, can cause dizziness, altered consciousness, or fainting (orthostatic hypotension). In such a situation, the patient should be laid on their back and their legs raised. If the symptoms do not resolve, you should contact your doctor immediately.
If you have any further questions about the use of this medicine, please ask your doctor.

4. Possible side effects

Like all medicines, Tachyben can cause side effects, although not everybody gets them.
The following side effects may occur during treatment. You should tell your doctor about them, who will decide whether to stop or continue treatment.
Common: may affect up to 1 in 10 people:nausea, dizziness, and headaches.
Uncommon: may affect up to 1 in 100 people:palpitations, decreased or increased heart rate, feeling of pressure or pain behind the breastbone (as in angina pectoris) and difficulty breathing, drop in blood pressure when changing body position (orthostatic hypotension), vomiting, fatigue, irregular heartbeat, and sweating.
Rare: may affect up to 1 in 1,000 people:prolonged and painful erection, nasal congestion, skin allergic reactions (itching, sudden redness of the skin, rash).
Very rare: may affect up to 1 in 10,000 people:decreased platelet count (blood cells involved in blood clotting), anxiety.
Frequency not known: cannot be estimated from the available data:facial, lip, tongue, and throat swelling, hives.
If you experience any side effects not listed in this leaflet, please inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tachyben

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule after EXP.
The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
After first opening and (or) dilution:
It has been demonstrated that the 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 solution is not administered immediately after preparation, the time and conditions of storage before administration are the responsibility of the medical staff and usually should not exceed 24 hours at a temperature of 2 to 8°C, unless the solution was prepared in controlled and validated aseptic conditions.
For single use only.
Use immediately after opening the ampoule.
Medicines should not be disposed of via wastewater or household waste. Please 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

What Tachyben contains

The active substance is urapidil.
One 5 ml ampoule contains 25 mg of urapidil.
One 10 ml ampoule contains 50 mg of urapidil.
The other ingredients are:
propylene glycol (see section 2)
sodium dihydrogen phosphate dihydrate
hydrochloric acid (37% w/w)
disodium phosphate dihydrate
hydrochloric acid (3.7% w/w)
sodium hydroxide (4% w/w)
water for injections

What Tachyben looks like and contents of the pack

Tachyben 25 mg is a solution for injection, which can also be diluted for infusion.
Tachyben 50 mg is a solution for injection, which can also be diluted for infusion.
Clear, colorless solution with a pH of 5.6 to 6.6.
Without visible impurities.
The pack contains 5 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

EVER Neuro Pharma GmbH
Oberburgau 3
4866 Unterach
Austria

Manufacturer

EVER Neuro Pharma GmbH
Oberburgau 3
4866 Unterach
Austria
CENEXI
52, rue Marcel et Jacques Gaucher
94120 Fontenay Sous Bois
France

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

Austria
Tachyben 25 mg Injektionslösung
Tachyben 50 mg Injektionslösung
Czech Republic
Tachyben 25 mg Injekční roztok
Tachyben 50 mg Injekční roztok
Germany
Urapidil Stragen i.v. 25 mg Injektionslösung
Urapidil Stragen i.v. 50 mg Injektionslösung
Romania
Tachyben, 25 mg, Soluţie injectabilă
Tachyben, 50 mg, Soluţie injectabilă
Hungary
Uratens i.v., 25 mg, Oldatos injekció
Uratens i.v., 50 mg, Oldatos injekció
Italy
Urapidil Stragen i.v., 25 mg, Soluzione iniettabile
Urapidil Stragen i.v., 50 mg, Soluzione iniettabile
Date of last revision of the leaflet:14.04.2021
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Information intended for healthcare professionals only:

Incompatibilities

Do not mix the medicinal product with other medicinal products, except for those listed below.
The following active substances (or solutions for dissolution or dilution) should not be administered simultaneously:
injections and infusion solutions with an alkaline reaction.
This may cause clouding or precipitation.

Special precautions for disposal

The 100 mg ampoule can only be used for stabilizing blood pressure in the form of an infusion.
To start treatment, ampoules containing 25 mg and 50 mg of urapidil are available. These doses, after dilution, can also be used in the form of an infusion.
Dilution should be performed under aseptic conditions.
Before administration, the color and purity of the solution should be checked. Only a clear and colorless solution can be administered.
Preparation of the solution:

• Intravenous injection: 250 mg of urapidil (2 ampoules containing 100 mg of urapidil + 1 ampoule containing 50 mg of urapidil) should be added to 500 ml of one of the listed solutions.
• Syringe pump: 100 mg of urapidil should be drawn into a syringe and diluted to a volume of 50 ml with one of the listed solutions.

Solutions for dilution:

• sodium chloride solution 9 mg/ml (0.9%)
• glucose solution 50 mg/ml (5%)
• glucose solution 100 mg/ml (10%)

For single use only.
Any unused solution and packaging should be disposed of in accordance with local regulations.