Tachyben

Package leaflet: Information for the patient

Tachyben, 100 mg, concentrate for solution for infusion
Urapidyl
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet:

1. What Tachyben is and what it is 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 Tachyben is and what it is used for

Tachyben contains the active substance urapidil.
Tachyben belongs to a group of medicines called alpha-blockers. These medicines act on blood vessels (i.e. arteries and veins). They reduce blood pressure by decreasing the tone of the blood vessel walls.
Tachyben is used to treat sudden, severe high blood pressure:

• in cases of acute high blood pressure threatening damage to 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has a heart condition called aortic stenosis or vascular abnormalities known as fistula (except for arteriovenous fistula in dialysis patients).

Warnings and precautions:
Before starting treatment with Tachyben, the doctor will check:

• whether the patient has had diarrhoea or vomiting (or other conditions causing reduced fluid volume in the body);
• whether there is decreased concentration of sodium in the blood.

Tachyben with other medicines
You must 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, because they may interact with Tachyben, potentially altering its effectiveness or increasing the risk of adverse effects:

• Medicines belonging to the group of alpha-receptor blockers used to treat urinary problems caused by prostate disease;
• Any medicines that lower blood pressure;
• Baclofen (used to treat muscle spasms);
• Cimetidine (used to inhibit gastric 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 using Tachyben and consuming alcohol. Alcohol may enhance the effect of urapidil.

Pregnancy, breastfeeding and fertility
Tachyben is not recommended for women of childbearing potential who are not using an effective method of contraception.
There is insufficient data to assess the safety of urapidil use in pregnant women.
Tachyben is not recommended during pregnancy unless the physician considers that the benefit to the mother outweighs the potential risk to the foetus.
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 unknown.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Driving and operating machinery
Tachyben may affect the ability to drive and operate machinery, particularly:

• at the beginning of treatment or when the dose is changed;
• when alcohol or alcoholic beverages are consumed.

If any adverse effects occur, the patient should not drive or operate machinery until symptoms have resolved.

Tachyben 100 mg contains sodium
Tachyben 100 mg, solution for injection, contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

Tachyben 100 mg contains propylene glycol
Tachyben 100 mg, solution for injection, contains 2000 mg of propylene glycol per ampoule, which may cause symptoms similar to those after alcohol consumption and may increase the likelihood of adverse effects.

This medicine must not be used in children under 5 years of age.
This medicine should only be used on a doctor's prescription. The doctor may decide to perform additional tests in patients receiving this medicine.

3. How to use Tachyben

Tachyben will be prescribed by a doctor and administered by a doctor or qualified medical personnel.
Dosage
The doctor will decide the appropriate dose of the medicine depending on the patient's condition.
Special patient groups

• Tachyben is not recommended for use in children and adolescents under 18 years of age due to lack of data on efficacy and safety.
• In elderly patients (over 65 years of age), a dose reduction may be necessary.
• In patients with liver disease (severe hepatic impairment), a dose reduction may be necessary.
• In patients with kidney disease (severe renal impairment), tests to assess blood circulation may be required.
• In patients with heart failure caused by mechanical dysfunction, 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 when the patient is standing may cause dizziness, disturbances of consciousness or fainting (orthostatic hypotension). In such a case, the patient should be laid on their back with legs elevated. If symptoms do not resolve, contact a doctor immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment. You should inform your doctor, who will decide whether to discontinue or continue treatment.
Common: may occur in 1 out of 10 patients: nausea, dizziness, and headache.
Uncommon: may occur in 1 out of 100 patients: palpitations, decreased or increased heart rate, feeling of pressure or pain behind the breastbone (as in angina pectoris), breathing difficulties, drop in blood pressure upon changing body position (orthostatic hypotension), vomiting, fatigue, irregular heartbeat, and sweating.
Rare: may occur in 1 out of 1,000 patients: prolonged and painful penile erection (priapism), nasal mucosa congestion, skin allergic reactions (itching, sudden redness of the skin, rash).
Very rare: may occur in 1 out of 10,000 patients: decrease in platelet count (blood cells involved in blood clotting), restlessness.
Frequency not known: cannot be estimated based on available data: facial swelling, lip swelling, tongue and throat swelling, urticaria.
If any adverse symptoms occur that are not listed in this leaflet, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Tachyben

The medicine should be stored in a place inaccessible and out of sight 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 stated month.
Store below 30°C.
After first opening and (or) dilution:
The infusion solution has been shown to be chemically and physically stable for 50 hrs 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 person responsible for storage conditions and duration prior to administration is the medical personnel, and storage should generally not exceed 24 hours at a temperature of 2 to 8°C, unless the solution was prepared under controlled and validated aseptic conditions.
For single use only.
Must be used immediately after first opening of the ampoule.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Tachyben contains
The active substance is urapidil.
One 20 ml ampoule contains 100 mg of urapidil.
The other components are:
propylene glycol (see section 2.)
disodium 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 100 mg is a concentrate for solution for infusion.
A clear, colourless solution with a pH between 5.6 and 6.6.
Free from visible particles.
The pack contains 5 ampoules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Austria Urapidil EVER Pharma 100 mg Konzentrat zur Herstellung einer Infusionslösung
Czech Republic Tachyben i.v. 100 mg Koncentrát pro přípravu infuzního roztoku
Germany Urapidil Stragen i.v. 100 mg Konzentrat zur Herstellung einer Infusionslösung
Portugal Urapidilo EVER Pharma 100 mg Concentrado para solução para perfusão
Romania Tachyben, 100 mg, Concentrat pentru soluţie perfuzabilă
Slovakia Tachyben 100 mg Infúzny koncentrát

Information intended exclusively for medical professionals:

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

Special precautions for disposal
The 100 mg vial is intended exclusively for blood pressure stabilization via infusion.
For initiating treatment, vials containing 25 mg and 50 mg of urapidil are available. These doses, after dilution, may also be administered as an infusion.
Dilution must be performed under aseptic conditions.
Before administration, check the solution for discoloration and presence of particulate matter. Only clear, colorless solutions should be administered.

Preparation of the solution:

• Intravenous infusion: add 250 mg of urapidil (2 vials containing 100 mg urapidil + 1 vial containing 50 mg urapidil) to 500 ml of one of the following diluents.
• Syringe pump: draw 100 mg of urapidil into a syringe and dilute to a final volume of 50 ml with one of the following diluents.

Diluents:

• 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 portions of the solution and packaging materials must be disposed of in accordance with local regulations.