URAPIDIL 50 mg Roztwór Do Wstrzykiwań

Treść ulotki

1. URAPIDIL STRAGEN
2. urapidil
   1. What is URAPIDIL STRAGEN and what is it used for
   2. What you need to know before using URAPIDIL STRAGEN
   3. How to take URAPIDIL STRAGEN
   4. Possible side effects
   5. How to store URAPIDIL STRAGEN
   6. Contents of the pack and other information
3. URAPIDIL STRAGEN 50 mg is an injectable solution that can also be diluted for

URAPIDIL STRAGEN

50 mg injectable solution

urapidil

Generic medicine

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, ask your doctor.
• If any side effects occur, including any not listed in this leaflet, tell 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 you are given 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 is URAPIDIL STRAGEN and what is it used for

URAPIDIL STRAGEN contains the active ingredient Urapidil.
URAPIDIL STRAGEN belongs to the group of medicines called alpha blockers. The action of this
medicine is localized 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 any of the other ingredients of this medicine (listed in section 6).
• if you have a heart condition known as aortic stenosis or a blood vessel condition known as a cardiac shunt (except for cardiac shunts in patients undergoing dialysis).

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

• if you have had diarrhoea or vomiting (or any other cause of fluid loss in the body);
• if you have low sodium levels in your blood.

Other medicines and URAPIDIL STRAGEN
Tell 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-blockers used for urinary problems caused by prostate disease
• Any medicine that lowers blood pressure
• Baclofen (used to treat muscle spasms)
• Cimetidine (used to inhibit acid production in the stomach)
• Imipramine and neuroleptics (used to treat depression)
• Corticosteroids (anti-inflammatory agents, sometimes called “steroids”).

URAPIDIL STRAGEN and alcohol
Be careful if you drink alcohol during treatment with URAPIDIL STRAGEN. It may increase
the effect of Urapidil.

Pregnancy and breastfeeding
The use of URAPIDIL STRAGEN i.v. during pregnancy is not recommended. There is no
adequate information to assess the safety of using Urapidil in pregnant women.
If you experience a rise in blood pressure during pregnancy and need to be treated
with this medicine, the reduction in blood pressure should be gradual and, in any case,
should always be monitored by a doctor.
There are no data on 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 are pregnant or are planning a pregnancy, ask
your doctor for advice before taking this medicine.

Driving and using machines
The use of URAPIDIL STRAGEN may affect your ability to drive vehicles or operate
machinery, particularly:

• at the start of treatment or if the treatment is changed;
• if you are taking alcohol at the same time.

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

URAPIDIL STRAGENcontains polypropylene glycol.This ingredient can cause symptoms
similar to those of alcohol.

URAPIDIL STRAGENcontains less than 23 mg of sodium per vial,i.e. it is essentially “sodium-free”. This means that you can use it even if you are on a low-salt diet.

3. How to take URAPIDIL STRAGEN

Take URAPIDIL STRAGEN following exactly the instructions of your doctor and if,
administered by qualified healthcare professionals.

Dosage
The doctor will decide the appropriate dosagebased on your state of health.

Special patient groups

• Use in children under 18 years of age is not recommended due to a lack of information on safety and efficacy.
• For elderly people (over 65 years), a reduction in the dose may be necessary.
• If you suffer from liver disease (severe hepatic impairment), the dosage must be reduced.
• If you suffer from kidney disease (renal dysfunction), tests may be needed to monitor your blood circulation.
• If you suffer from 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 should 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
when getting up, which causes dizziness, confusion or fainting (orthostatic hypotension). In this case, the patient should be placed on their back with their legs raised. If the symptoms
persist, contact your doctor immediately.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment. You should contact your
doctor, who will decide whether to suspend 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, increase or decrease in
heart rate, feeling of pressure or pain in the chest (like angina pectoris) and difficulty
breathing, low blood pressure when changing position (orthostatic hypotension), vomiting,
fatigue, irregular heartbeat and sweating.

Rare: may affect up to 1 in 1,000 patients: prolonged and painful erection, nasal congestion,
allergic skin reactions (itching, unusual skin redness, rash).

Very rare: may affect up to 1 in 10,000 patients: reduced number of platelets (blood
cells involved in coagulation), restlessness.

Not known: frequency cannot be estimated from available data:swelling of the face, lips,
tongue and throat, urticaria.
If any side effect occurs, including those not listed in this leaflet, please
tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system,
via the national reporting system website at 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 which is stated on the package and on the vial after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
After first opening/dilution
Physical and chemical stability has been demonstrated for 50 hours at 15-25°C.
From a microbiological point of view, the product must be used immediately.
If not used immediately, storage times and conditions are the responsibility
of the user and must not exceed 24 hours between 2 and 8°C, unless the 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of URAPIDIL STRAGEN and contents of the pack

URAPIDIL STRAGEN 50 mg is an injectable solution that can also be diluted for

infusion.
Clear, colorless solution with a pH of 5.6 to 6.6.
Free from visible particles.
.
One box 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 authorised in the Member States of the EEA under the following denominations:
Germany: Urapidil Stragen i.v. 50 mg Injection solution

Austria: Tachyben 50 mg Injection solution

Bulgaria: Tахибен, 50 mg, Injection solution

Czech Republic: Tachyben 50 mg Injection solution

Estonia: Tachyben, 50 mg, Injection solution

Hungary: Uratens i.v., 50 mg, Solution for injection

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
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The following information is intended for healthcare professionals only:
Incompatibilities
This medicinal product must not be mixed with other medicinal products except with the solvents mentioned
below.
The following active substances [or solution for reconstitution/dilution] must not be
administered simultaneously:
alkaline infusion or injectable solutions.
This may cause turbidity or flocculation.

Special precautions for disposal
Vials containing 25 mg and 50 mg of urapidil are available for initial treatment. These
dosages can also be used for intravenous infusion after dilution.
Dilution takes place under aseptic conditions.
The solution must be visually inspected for the presence of particles and
color change before administration. Only clear and colorless solutions must be used.
Preparation of the 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 volume of 50 ml with one of the compatible solvents.

Compatible solvents for dilution

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

For single use only
Any unused solution and the “bags/pouches” must be disposed of appropriately in accordance with local regulations.