Tahiben

Package Leaflet: Information for the Patient

Tachyben, 25 mg, Solution for Injection

Tachyben, 50 mg, Solution for Injection

Urapidil

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Table of Contents of the Package 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 the blood vessels (i.e., arteries and veins). They cause a decrease in blood pressure by reducing the tension in the blood vessel walls.
Tachyben is used to treat sudden, severe increases in blood pressure:

• in situations where a sudden increase in blood pressure threatens to damage sensitive organs;
• during and after surgical procedures.

2. Important information before using Tachyben

When not to use Tachyben:

• if you are allergic to urapidil or any of the other ingredients of this medicine (listed in section 6).
• if you have a heart defect called aortic stenosis or vascular abnormalities called shunts (except for arteriovenous shunts in dialysis patients).

Warnings and precautions

Before starting treatment with Tachyben, your doctor will check:

• if you have had diarrhea or vomiting (or other conditions that cause a decrease in fluid volume in the body);
• if you have a decrease in sodium levels in the blood.

Tachyben and other medicines

Tell your doctor about all the 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

Be careful when taking Tachyben and drinking alcohol, as this may enhance the effects of urapidil.

Pregnancy, breastfeeding, and fertility

Tachyben should not be used in women of childbearing age who are not using effective contraception.
There is insufficient data to assess the safety of urapidil in pregnant women.
Tachyben should not be used during pregnancy, unless your doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
It is not known whether Tachyben passes into breast milk. As a precaution, breastfeeding should be avoided while taking 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, 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.
Your doctor may decide to perform additional tests on you while 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.
Your doctor may decide to perform additional tests on you while 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 on the appropriate dose of the medicine, depending on your condition.

Special patient groups

• Tachyben should not be used in children and adolescents under 18 years of age, due to the lack of data on efficacy and safety.
• In elderly patients (over 65 years), a dose reduction may be necessary.
• If you have liver disease (severe liver failure), a dose reduction may be necessary.
• If you have kidney disease (severe renal failure), blood circulation tests may be necessary.
• If you have heart failure caused by 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, impaired 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, contact your doctor immediately.
If you have any further questions about the use of this medicine, 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. 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 headache.
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 package leaflet, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, 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,
Jerozolimskie Avenue 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 the 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 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. 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.
No 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 package 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 pH.
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.
For the start of 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, check the color and purity of the solution. Only clear and colorless solutions can be administered.
Preparation of the solution:

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

Solutions for dilution:

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

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