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1. URASAP 25 mg/5 ml injectable solution for intravenous use, 50 mg/10 ml injectable solution for intravenous use, 100 mg/20 ml injectable solution for intravenous use
   1. What is URASAP and what is it used for
   2. What you need to know before using URASAP
   3. How to use URASAP
   4. Possible side effects
   5. How to store URASAP
   6. Package contents and other information
2. Urasap 50 mg/10 ml injectable solution) with 500 ml of a compatible infusion solution

URASAP 25 mg/5 ml injectable solution for intravenous use, 50 mg/10 ml injectable solution for intravenous use, 100 mg/20 ml injectable solution for intravenous use

Urapidil
Generic medicine

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is URASAP and what is it used for

Urasap contains the active ingredient urapidil
Urasap belongs to a group of medicines called alpha blockers. The site of action of this
medicine is located in the blood vessels (e.g. arteries or veins). It reduces blood
pressure by relaxing the walls of the vessels.
Urasap is used for:

• hypertensive emergencies (e.g. a dangerous increase in blood pressure)
• severe to extremely severe forms of high blood pressure
• high blood pressure that cannot be treated otherwise
• controlled reduction of blood pressure in patients with high blood pressure during or after surgical procedures.

2. What you need to know before using URASAP

Do not take URASAP

• if you are allergic to urapidil or any of the other ingredients of this medicine (listed in section 6).
• in patients with a narrowing of the main artery (aortic isthmus stenosis) and an abnormal connection between an artery and a vein (arteriovenous shunt - exception: hemodynamically ineffective dialysis shunt).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Urasap.

Before using URASAP your doctor must consider:

• If you have had diarrhea or vomiting (or any other cause that has determined a reduction of fluids in your body)
• If the amount of sodium in your blood has decreased.

Be careful with URASAP especially

• if you have mechanical heart failure, e.g. caused by a narrowing of the heart valves (aortic valve stenosis or mitral valve stenosis), if you have pulmonary embolism or limited heart function caused by a pericardial disease (affecting the sac surrounding the heart)
• in children (0-18 years), as there is not enough data available
• in patients with liver dysfunction
• in patients with moderate to severe kidney dysfunction
• in elderly patients
• in patients receiving cimetidine (a medicine used to reduce stomach acidity) (see section “Other medicines and URASAP”). In each of these cases, contact your doctor.

If Urasap is administered as an additional treatment for high blood pressure:
Sufficient time must be given for the previous antihypertensive drug to produce its
effect. The doctor will consequently select a lower dose of Urasap. If
the lowering of blood pressure is too rapid, bradycardia (slow heartbeat) or a
heart attack may occur.
The antihypertensive effect of Urasap may be amplified by the following factors:

• dehydration, which can be caused by diarrhea or vomiting
• alcohol use.

Other medicines and URASAP
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking any of the following medicines that may interact with Urasap
because this may alter their effectiveness or increase the likelihood of side
effects:

• Alpha-blockers, used as well as antihypertensives also for urinary problems caused by prostate affections. Any drug that reduces blood pressure
• Baclofen (used for the treatment of muscle spasms)
• Cimetidine (used to inhibit stomach acid production)
• Imipramine and neuroleptics (used to treat depression)
• Corticosteroids (anti-inflammatory drugs, also called steroids).

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The use of Urasap during pregnancy is not recommended
However, if an increase in blood pressure occurs during pregnancy and it is
necessary to use Urasap, the reduction in pressure must be gradual and always monitored
by the doctor.
Urasap should not be administered during breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.

Driving and using machines
Do not drive vehicles and do not use tools or machinery, as your reaction ability may be
impaired. This occurs particularly at the beginning of treatment, when increasing the dosage
or following a change from another drug, as well as when interacting with alcohol.
If you feel unwell, it is not advisable to drive or use machinery until the symptoms have
disappeared.

URASAP contains propylene glycol
This medicine contains 100 mg of propylene glycol per ml of solution.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor.
Propylene glycol in this medicine may give effects that occur when drinking alcohol and may
increase the likelihood of side effects.
Do not use this medicine in children under 5 years of age.
Use this medicine only if recommended by your doctor. The doctor may perform further checks
during therapy.

URASAP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially
sodium-free.

3. How to use URASAP

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Urasap is administered to you by the doctor, who will decide the most appropriate dosage for you and the
duration of treatment needed.
Urasap is administered intravenously as an injectable solution or infusion, with the
patient lying down. Both single or repeated injections and long-term intravenous infusions are possible. Injections can be combined with a subsequent long-term infusion. In
overlap with injections or infusion during acute therapy, it is possible to switch to maintenance therapy with oral antihypertensive drugs in the form of tablets,
capsules or similar.
A treatment duration of 7 days is safe and should not be exceeded.

How often and how much URASAP should be used?
For marked and critical increases in blood pressure (hypertensive emergency), severe and
extremely severe forms of hypertension and hypertension refractory to therapy

• 1) Intravenous injection:10-50 mg of urapidil are administered by slow intravenous injection, along with constant blood pressure monitoring. The blood pressure lowering effect is expected within 5-10 minutes of the injection. Depending on the response to blood pressure, the Urasap injection can be repeated.
• 2) Slow intravenous infusion (fleboclisis) or continuous infusion using an infusion pump (dosing pump used for the continuous administration of drugs intravenously):In order to maintain the blood pressure levels achieved with the injection, slow infusion solutions are reconstituted as described in section 5.

Administration rate:
The infusion rate should be based on the individual blood pressure response.
Recommended initial rate: 2 mg/minute.
Maintenance dose: 9 mg/hour on average: when 250 mg of urapidil are added to 500 ml
of infusion solution, 1 mg is equivalent to 2.2 ml = 44 drops.
Controlled reduction of blood pressure in patients with increased blood pressure during or
after surgery
To maintain the blood pressure levels achieved with the injection, a slow
infusion (fleboclisis) or a continuous infusion using an infusion pump is established.
Dosage schedule:
Intravenous injection of
25 mg of urapidil
(= 5 ml of injectable solution)
if the pressure
decreases after 2 min
Stabilization of the
pressure
by infusion
Initially, up to
6 mg over 1-2
minutes,
followed by a
reduction of the
dose
none
after 2 min blood pressure
response
Intravenous injection of
25 mg of urapidil
(= 5 ml of injectable solution)
if the pressure
decreases after 2 min
none
after 2 min blood pressure
response
Special patient groups

Use in children and adolescents
Use in children and adolescents under the age of 18 is not recommended due to
lack of safety and efficacy data.
A dose reduction may be necessary in elderly patients.
If you suffer from renal or hepatic dysfunction, the dose must be reduced.
If you suffer from heart failure caused by mechanically induced functional damage, special precautions must be taken.

If you are given too much URASAP
An increase in undesirable effects may occur as a result of an overdose, e.g.:

• related to circulation: dizziness, ringing in the ears, black spots in the eyes (orthostatic syndrome), collapse
• related to the central nervous system: fatigue and slowed reflexes (see also section 4. Possible side effects).

Treatment in case of overdose:
An excessive drop in blood pressure can be corrected by raising the legs and administering
infusion solutions capable of stabilizing blood circulation (volume restoring agents). If these measures are inadequate, vasodilators can be administered by slow intravenous injection, while monitoring blood pressure. The
administration of catecholamines is necessary in very rare cases (e.g., adrenaline 0.5-1 mg diluted
to 10 ml with isotonic saline solution).
If you have further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects listed below gets serious, or if you notice any side effects not listed here, please tell your doctor or pharmacist.

Common(may affect up to 1 in 10 people): dizziness, headache, nausea;

Uncommon(may affect up to 1 in 100 people): palpitations, fast or slow heartbeat (tachycardia or bradycardia), feeling of pressure or pain in the chest (symptoms similar to angina pectoris), shortness of breath (dyspnea), decrease in blood pressure when changing position, e.g. when getting up from a lying position (orthostatic dysregulation), sudden sweating, fatigue, vomiting, irregular heartbeat.

Rare(may affect up to 1 in 1,000): blocked nose, allergic symptoms (itching, redness of the skin, rash), persistent erection (priapism);

Very rare(may affect up to 1 in 10,000): agitation, sleep disorders, involuntary loss of urine (urinary incontinence, involuntary loss of urine during the night (nocturnal enuresis), blood clotting problems (decreased platelet count);
Frequency not known (the frequency cannot be estimated on the basis of the available data): swelling of the face, mouth, tongue, or throat (angioedema), itchy rash (urticaria).
In most cases, the side effects listed are due to an excessive drop in blood pressure. However, experience has shown that they disappear within a few minutes, even during long-term infusion.
Depending on the severity of the side effects, a decision will need to be made about whether to discontinue treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store URASAP

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 label and on the packaging
after Exp. The expiry date refers to the last day of that month.

Storage conditions
Do not store at a temperature above 30°C.

Notes on validity after opening or reconstitution
The chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at 25°C. From
a microbiological point of view, the ready-to-use preparation must be used
immediately. If not used immediately, the storage times and conditions after
opening are the responsibility of the user.
For the opened vial, a validity of 24 hours has been demonstrated when stored at 2-8°C.
For single use only
Use immediately after first opening of the vials.
Do not dispose of any medicine in the drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What URASAP contains

• The active ingredient is urapidil. 1 ml of injectable solution contains 5 mg of urapidil.
• The other ingredients are: propylene glycol, disodium phosphate dihydrate, monosodium phosphate, water for injections and (for pH adjustment): 36% hydrochloric acid, sodium hydroxide.

Description of the appearance of URASAP and package contents
Urasap injectable solution for intravenous use is a clear and colorless solution contained in
glass vials with pre-break points (transparent glass type I conforming to the requirements of the
European Pharmacopoeia).
Urasap is available in the following presentations:
“25 mg/5 ml injectable solution for intravenous use”, 1 vial of 5 ml (= 25 mg of urapidil)
“50 mg/10 ml injectable solution for intravenous use”, 5 vials of 10 ml (= 50 mg of urapidil)
“100 mg/20 ml injectable solution for intravenous use”, 5 vials of 20 ml (= 100 mg of urapidil).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AIC Holder:
INCA-Pharm S.r.l.
Via Marittima, 38 – 03100 Frosinone

Manufacturer responsible for batch release:
Haupt Pharma Wülfing GmbH
Bethelner Landstrasse, 18 – 31028 Gronau/Leine, Germany

The following information is intended for healthcare professionals only:

Incompatibilities
This medicine must not be mixed with other medicines except for the compatible solvents
listed below.
Urasap must not be mixed with other injectable solutions or alkaline infusion solutions,
as clouding or flocculation may occur due to the acidic properties of the
Urasap solution.

Special precautions for use:
The 100 mg vials can only be used to stabilize blood pressure for
infusion.
For initiating treatment, vials containing 25 mg and 50 mg of urapidil are available.
Dilution must be carried out under aseptic conditions.
Before administration, visually inspect the solution and check for
particles and color changes. Use only clear and colorless solutions.
Preparation of the diluted solution:

• Intravenous infusion: dilute 200-250 mg of urapidil (4-5 vials of Urasap 50 mg/10 ml injectable solution or 2 vials of Urasap 100 mg/20 ml injectable solution + 1 vial of

Urasap 50 mg/10 ml injectable solution) with 500 ml of a compatible infusion solution

compatible (see below).

• When using an infusion pump for continuous infusion, draw 20 ml of the injectable solution (= 100 mg of urapidil, corresponding to 2 vials of Urasap 50 mg/10 ml injectable solution or 1 vial of Urasap 100 mg/20 ml injectable solution) into the pump syringe and dilute to a volume of 50 ml with a compatible infusion solution (see below). The maximum compatible concentration of urapidil is 4 mg/ml.

Compatible solvents for dilution:
Sodium chloride solution, 5% or 10% glucose solution.
For single use only.
Unused medicine and waste materials derived from it must be disposed of in accordance with
current local regulations.