Urapidil Stragen

Package leaflet: Information for the user

URAPIDIL STRAGEN

50 mg injectable solution
urapidil
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains
important information for you.

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

Contents of this leaflet:

1. What URAPIDIL STRAGEN is and what it is used for
2. What you need to know before being administered URAPIDIL STRAGEN
3. How to use URAPIDIL STRAGEN
4. Possible side effects
5. How to store URAPIDIL STRAGEN
6. Contents of the pack and other information

1. What URAPIDIL STRAGEN is and what it is used for

URAPIDIL STRAGEN contains the active substance Urapidil.
URAPIDIL STRAGEN belongs to the group of medicines known as alpha-blockers. The action of this
medicine is located in the blood vessels (e.g. arteries and veins). It reduces blood pressure by
relaxing the walls of the blood vessels.
URAPIDIL STRAGEN is used for the treatment of severe cases of high blood pressure:

• in emergency situations when blood pressure is high, with organ damage that rapidly endangers life;
• during and/or after surgical procedures.

2. What you need to know before using URAPIDIL STRAGEN

Do not use URAPIDIL STRAGEN

• if you are allergic to urapidil or to any of the other ingredients of this medicine (listed in section 6);
• if you have a known heart condition called aortic stenosis or a known blood vessel condition called cardiac shunt (except for cardiac shunts in dialysis patients).

Warnings and precautions
Before using URAPIDIL STRAGEN, your doctor must check whether:

• you have had diarrhoea or vomiting (or any other cause of reduced body fluids);
• your blood sodium levels are decreased.

Other medicines and URAPIDIL STRAGEN
Inform your doctor if you are taking, or have recently taken, any other medicines.
Tell your doctor before using this medicine if you are taking any of the following medicines, as they may interact with URAPIDIL STRAGEN i.v. and this could alter their effectiveness or make side effects more likely:

• Alpha-blocking agents used for urinary problems caused by prostate disease;
• Any medicine that lowers blood pressure;
• Baclofen (used to treat muscle spasms);
• Cimetidine (used to inhibit stomach acid production);
• Imipramine and neuroleptics (used to treat depression);
• Corticosteroids (anti-inflammatory agents, sometimes called “steroids”).

URAPIDIL STRAGEN and alcohol
Be cautious if you drink alcohol during treatment with URAPIDIL STRAGEN, as it may enhance the effect of urapidil.
Pregnancy and breastfeeding
The use of URAPIDIL STRAGEN i.v. during pregnancy is not recommended. There are insufficient data to assess the safety of urapidil use in pregnant women.
If you develop high blood pressure during pregnancy and require treatment with this medicine, blood pressure reduction should be gradual and must always be monitored by a doctor.
There are no data regarding the passage of urapidil into breast milk. For safety reasons, breastfeeding is not recommended during treatment with URAPIDIL STRAGEN.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Driving and using machines
The use of URAPIDIL STRAGEN may affect your ability to drive or operate machinery, especially:

• at the beginning of treatment or when treatment is changed;
• if you consume alcoholic beverages at the same time.

If you feel unwell, it is not advisable to drive or use machinery until symptoms have resolved.
URAPIDIL STRAGEN contains propylene glycol. This ingredient may cause symptoms similar to those of alcohol.
URAPIDIL STRAGEN contains less than 23 mg of sodium per vial, meaning it is essentially “sodium-free”. This means you may use it even if you are on a low-salt diet.

3. How to take URAPIDIL STRAGEN

Take URAPIDIL STRAGEN exactly as prescribed by your doctor and,
if administered by specialized healthcare personnel.
Dosage
Your doctor will determine the appropriate dosage based on your health status.
Special patient groups

• Use in children under 18 years of age is not recommended due to lack of information on safety and efficacy.
• In elderly patients (over 65 years of age), a reduced dosage may be necessary.
• If you have liver disease (severe hepatic insufficiency), the dosage should be reduced.
• If you have kidney disease (renal dysfunction), monitoring tests may be required to control your blood circulation.
• If you have heart failure caused by impaired mechanical function, special precautions must be taken.

Method of administration
URAPIDIL STRAGEN is administered intravenously.
Duration of treatment
The duration of treatment with URAPIDIL STRAGEN must not exceed 7 days.
If you take more URAPIDIL STRAGEN than you should
The main event in case of overdose is a sudden drop in blood pressure upon standing, causing dizziness, mental confusion, or fainting (orthostatic hypotension). In this case, the patient should be placed on their back with legs raised. If symptoms persist, contact your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur during treatment. You should contact your doctor, who will decide whether to stop or continue treatment.
Common: may affect up to 1 in 10 patients: Nausea, dizziness and headache.
Uncommon: may affect up to 1 in 100 patients: Palpitations, increased or decreased heart rate, sensation of pressure or chest pain (as in angina pectoris), shortness of breath, drop in blood pressure when changing position (orthostasis), vomiting, fatigue, irregular heartbeat and sweating.
Rare: may affect up to 1 in 1,000 patients: Prolonged and painful erection, nasal congestion, skin allergic reactions (itching, unusual redness of the skin, rash).
Very rare: may affect up to 1 in 10,000 patients: Reduction in the number of platelets (blood clotting cells), restlessness.
Not known: frequency cannot be estimated based on available data: Swelling of the face, lips, tongue and throat, urticaria.
If you experience any side effect, including those not listed in this leaflet, contact your doctor.
Reporting of side effects
If you experience any side effect, contact your doctor or nurse. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store URAPIDIL STRAGEN

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 vial after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
After first opening/dilution
Physical and chemical stability has been demonstrated for 50 hours at 15–25°C.
From a microbiological standpoint, the product should be used immediately.
If not used immediately, the duration and conditions of storage are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
For single use only.
Use immediately after first opening of the vial.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What URAPIDIL STRAGEN contains
The active substance is Urapidil.
One 10 ml vial contains 50 mg of Urapidil.
The other ingredients are:
Propylene glycol (see section 2),
Disodium dihydrogen phosphate dihydrate,
Hydrochloric acid (37% w/w),
Disodium hydrogen phosphate dihydrate,
Hydrochloric acid (3.7% w/w),
Sodium hydroxide (4% w/w),
Water for injections.

Description of the appearance of URAPIDIL STRAGEN and package contents
URAPIDIL STRAGEN 50 mg is an injectable solution which may also be diluted for infusion.
Clear, colourless solution with a pH between 5.6 and 6.6.
Free from visible particles.
One carton contains 5 vials.

Marketing Authorization Holder
Stragen Nordic A/S
Helsingørsgade 8C
DK-3400 Hillerød
Denmark

Manufacturer
CENEXI
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

This medicinal product is authorized in the EEA Member States under the following names:
Germany: Urapidil Stragen i.v. 50 mg Injektionslösung
Austria: Tachyben 50 mg Injektionslösung
Bulgaria: Tахибен, 50 мг, Инжекционен разтвор
Czech Republic: Tachyben 50 mg Injekční roztok
Estonia: Tachyben, 50 mg, Süstelahus
Hungary: Uratens i.v., 50 mg, Oldatos injekció
Latvia: Tachyben, 50 mg, šķīdums injekcijai
Lithuania: Tachyben, 50 mg, Injekcinis tirpalas
Poland: Tachyben, 50 mg, Roztwór do wstrzykiwań
Portugal: Tachyben, 50 mg, Solução injetável
Romania: Tachyben, 50 mg, Soluţie injectabilă
Slovakia: Tachyben, 50 mg, Injekčný roztok

The following information is intended for healthcare professionals only:

Incompatibilities
This medicinal product must not be mixed with other medicinal products except for the solvents specified below.
The following active substances [or reconstitution/dilution solutions] must not be administered simultaneously:
alkaline infusion or injectable solutions.
This may cause cloudiness or flocculation.

Special precautions for disposal
For initial treatment, vials containing 25 mg and 50 mg of urapidil are available. These dosage strengths may also be used for intravenous infusion after dilution.
Dilution must be performed under aseptic conditions.
The solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear and colourless solutions should be used.

Preparation of diluted solution

• Intravenous infusion: Add 250 mg of urapidil to 500 ml of one of the compatible solvents.
• Syringe pump: Withdraw 100 mg of urapidil using a syringe pump and dilute to a final volume of 50 ml with one of the compatible solvents.

Compatible diluents

• Sodium chloride 9 mg/ml (0.9%) solution for infusion
• Glucose 50 mg/ml (5%)
• Glucose 100 mg/ml (10%)

Single use only
Any unused solution and the "bags/pouches" must be properly disposed of in accordance with applicable local regulations.