URAPIDIL 25 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Urapidil KALCEKS, 25 mg, Solution for Injection/Infusion
3. Urapidil KALCEKS, 50 mg, Solution for Injection/Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
4. What is Urapidil KALCEKS and What is it Used For
5. Important Information Before Using Urapidil KALCEKS
   1. When Not to Use Urapidil KALCEKS
   2. Warnings and Precautions
   3. Children
   4. Urapidil KALCEKS and Other Medications
   5. Urapidil KALCEKS with Alcohol
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Using Machines
   8. Urapidil KALCEKS Contains Propylene Glycol and Sodium
6. How to Use Urapidil KALCEKS
   1. How to Use the Medication
   2. Dosage
   3. Special Patient Groups
   4. Treatment Duration
   5. Using More Than the Recommended Dose of Urapidil KALCEKS
7. Possible Side Effects
   1. Reporting Side Effects
8. How to Store Urapidil KALCEKS
9. Contents of the Package and Other Information
   1. What Urapidil KALCEKS Contains
   2. What Urapidil KALCEKS Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:
   5. Date of Last Revision of the Package Leaflet: 09/2022
   6. Dosage
   7. Scheme of Administration
   8. Special Patient Groups
   9. Children and Adolescents
   10. Method of Administration
   11. Incompatibilities
   12. Instructions for Use and Disposal

Package Leaflet: Information for the User

Urapidil KALCEKS, 25 mg, Solution for Injection/Infusion

Urapidil KALCEKS, 50 mg, Solution for Injection/Infusion

Urapidil

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Package Leaflet

• 1. What is Urapidil KALCEKS and What is it Used For
• 2. Important Information Before Using Urapidil KALCEKS
• 3. How to Use Urapidil KALCEKS
• 4. Possible Side Effects
• 5. How to Store Urapidil KALCEKS
• 6. Contents of the Package and Other Information

1. What is Urapidil KALCEKS and What is it Used For

Urapidil KALCEKS contains the active substance urapidil. Urapidil is a blood pressure lowering medication (antihypertensive agent) that belongs to a group of medications called "alpha-adrenergic receptor blockers". This medication works on blood vessels (i.e., arteries and veins). It lowers blood pressure by reducing the tension of blood vessels. This medication is used in adults:

• in cases of sudden high blood pressure (e.g., sudden, severe high blood pressure called "hypertensive crisis");
• to treat severe to very severe hypertension or resistant hypertension;
• to lower high blood pressure during and after surgical procedures.

2. Important Information Before Using Urapidil KALCEKS

When Not to Use Urapidil KALCEKS

• if the patient is allergic to urapidil or any of the other ingredients of this medication (listed in section 6);
• if the patient has narrowing of the main artery (aortic stenosis) or vascular abnormalities called "vascular shunt" (except for arteriovenous shunt in dialyzed patients);
• if the patient is breastfeeding.

Warnings and Precautions

If blood pressure drops too quickly, it may cause a decrease in heart rate or cardiac arrest. Before taking this medication, discuss with your doctor or nurse if any of the following points apply to you, as special caution is recommended:

• if the patient has had diarrhea or vomiting (or other conditions that reduce fluid in the body);
• in patients with heart failure due to mechanical damage, e.g., narrowing of the heart valve (aortic or mitral stenosis);
• in patients with pulmonary embolism;
• in patients with heart rhythm disorders caused by pericarditis (pericardial disease);
• in patients with liver disorders;
• in patients with moderate to severe kidney disorders;
• in elderly patients;
• in patients taking cimetidine (a medication that inhibits stomach acid production) at the same time. If you are not sure if any of the above applies to you, consult your doctor or nurse.

If the patient is having eye surgery for cataracts (lens clouding), they should inform the ophthalmologist before surgery that they are taking or have taken urapidil. This is because urapidil may cause complications during surgery that can be prevented if the specialist is prepared in advance. If urapidil is administered after another blood pressure lowering medication, the doctor will wait long enough for the previously administered medication to take effect. The doctor will reduce the dose of urapidil. Too rapid a drop in blood pressure may lead to a decrease in heart rate or cardiac arrest.

Children

This medication should not be used in children and adolescents.

Urapidil KALCEKS and Other Medications

Tell your doctor or nurse about all medications you are taking or have recently taken, as well as any medications you plan to take. Before using this medication, inform your doctor or nurse if you are taking any of the following medications, as they may interact with Urapidil KALCEKS, changing the effect of the medications or increasing the risk of side effects:

• alpha-adrenergic receptor blockers (used to treat urinary disorders related to prostate disease);
• any blood pressure lowering medications;
• cimetidine (used to inhibit stomach acid production);
• barbiturates (medications used to treat epilepsy).

Urapidil KALCEKS with Alcohol

Alcohol may enhance the effect of this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medication. There is insufficient data to assess the safety of urapidil in pregnant women. This medication should not be used during pregnancy unless necessary due to the woman's clinical condition. If high blood pressure occurs during pregnancy and treatment with this medication is necessary, blood pressure lowering should be gradual and always controlled by a doctor. It is not known whether the medication passes into breast milk. For safety reasons, this medication should not be used during breastfeeding. This medication is not recommended for women of childbearing age who do not use contraception. Animal studies have shown that urapidil affects fertility. However, the significance of this effect in humans is unknown.

Driving and Using Machines

This medication may affect your ability to drive and use machines, especially when starting treatment, increasing the dose, changing treatment, or in combination with alcohol.

Urapidil KALCEKS Contains Propylene Glycol and Sodium

Propylene Glycol:

• This medication contains 500 mg of propylene glycol per 5 ml of solution and 1,000 mg of propylene glycol per 10 ml of solution, which corresponds to 100 mg/ml.
• If you are pregnant or breastfeeding, do not use this medication unless your doctor recommends it. Your doctor may perform additional checks during treatment with this medication.
• If you have liver or kidney disease, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks during treatment with this medication.
• Propylene glycol in this medication may cause symptoms similar to those after alcohol consumption and increase the risk of side effects. Sodium:
• The medication contains less than 1 mmol (23 mg) of sodium per ml, which means the medication is considered "sodium-free".

3. How to Use Urapidil KALCEKS

How to Use the Medication

• This medication will be administered by medical personnel.
• This medication will be administered by injection or intravenous infusion. It may be administered as a single or multiple injections or as a continuous infusion. Injections may be combined (continued) with continuous infusions.
• During administration of this medication, the patient should be in a lying position.
• During treatment, the patient's blood pressure will be constantly monitored.

Dosage

The doctor will decide on the appropriate dose based on the patient's condition. Hypertensive crisis and severe to very severe hypertension or resistant hypertension Intravenous Injection10-50 mg of urapidil is administered slowly - with constant blood pressure monitoring. A decrease in blood pressure can be expected within 5 minutes after injection. Depending on the response of blood pressure, the injection of urapidil can be repeated. Intravenous Infusion (as a drip or using an infusion pump)In the case of continuous intravenous infusion, 250 mg of urapidil is added to 500 ml of compatible infusion solution (0.9% sodium chloride or 5% or 10% glucose solution). In the case of using an infusion pump, 100 mg of urapidil is drawn into the infusion pump and diluted to a volume of 50 ml with a compatible infusion solution (see above) (maximum 4 mg of urapidil per ml of infusion solution). The initial infusion rate is 2 mg/min. The maintenance dose is approximately 9 mg/hour. The degree of blood pressure reduction will be determined based on the dose administered during the first 15 minutes. The desired blood pressure level can then be maintained with significantly lower doses. Reducing high blood pressure during and after surgery To maintain the blood pressure level achieved by injection, a continuous infusion is used with an infusion pump or continuous intravenous infusion. By Intravenous InjectionInitially, 25 mg of urapidil is administered. This dose will be repeated if sufficient blood pressure reduction is not achieved after 2 minutes. If the blood pressure reduction is still insufficient after 2 minutes after the second dose, 50 mg of urapidil will be administered. If the blood pressure reduction is sufficient after 2 minutes after administration of the dose, the patient will receive a maintenance dose. Intravenous Infusion (by drip or infusion pump)Initially, up to 6 mg will be administered over 1-2 minutes, then the dose will be reduced.

Special Patient Groups

In patients with liver and/or kidney disease, it may be necessary to reduce the dose. In elderly patients, this medication must be administered with special caution, initially in small doses, due to the changed sensitivity of these patients to medications from this group.

Treatment Duration

The treatment duration with this medication should not exceed 7 days.

Using More Than the Recommended Dose of Urapidil KALCEKS

In case of administration of too high a dose of this medication, dizziness, feeling of emptiness in the head, or fainting when standing up, fatigue, and slowed reaction time may occur. In such a case, the patient should lie down with their legs elevated. If the symptoms do not disappear, the doctor or nurse should be notified immediately. In case of any doubts related to the use of this medication, consult a doctor or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everybody gets them. In most cases, the side effects listed below were related to too rapid a decrease in blood pressure; however, experience to date shows that even during slow infusion, they usually disappear within a few minutes. The doctor will decide whether to discontinue or not discontinue treatment, depending on the severity of the side effects. Frequent(may occur in up to 1 in 10 patients) Dizziness, headache, nausea. Uncommon(may occur in up to 1 in 100 patients) Sleep disorders, palpitations, decreased or increased heart rate, feeling of pressure or pain behind the breastbone (as in angina pectoris), breathing difficulties, drop in blood pressure when standing up from a sitting or lying position (orthostatic hypotension), vomiting, diarrhea, dry mouth, sweating, fatigue, irregular heartbeat. Rare(may occur in up to 1 in 1,000 patients) Nasal congestion, allergic reactions (itching, redness, rash), prolonged and painful erection. Very Rare(may occur in up to 1 in 10,000 patients) Anxiety, increased need to urinate, severe incontinence, decreased platelet count (blood cells involved in blood clotting). Frequency Not Known(frequency cannot be estimated from available data) Hives, severe allergic reaction with swelling of the face, lips, tongue, and throat.

Reporting Side Effects

If you experience any side effects, tell your doctor or nurse. This includes any side effects not listed in this leaflet. Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C PL-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. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Urapidil KALCEKS

Store the medication out of sight and reach of children. There are no special recommendations for storing the medicinal product. After dilution It has been shown that the chemical and physical stability is maintained for 50 hours at 25°C and 2-8°C after dilution in 9 mg/ml (0.9%) sodium chloride or 50 mg/ml (5%) or 100 mg/ml (10%) glucose solution for infusion. From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage time and conditions before use, which should not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution took place in controlled and validated aseptic conditions. Do not use this medication after the expiration date stated on the carton and on the ampoule after "EXP". The expiration date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Urapidil KALCEKS Contains

• The active substance is urapidil. 1 ml of solution contains 5 mg of urapidil. Each 5 ml ampoule contains 25 mg of urapidil. Each 10 ml ampoule contains 50 mg of urapidil.
• The other ingredients are: hydrochloric acid, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, propylene glycol, sodium hydroxide (for pH adjustment), water for injections.

What Urapidil KALCEKS Looks Like and Contents of the Package

Ampoules made of colorless glass type I, with a capacity of 5 ml or 10 ml with a break point (one point cut). 5 ampoules are packed in a blister pack. The whole is packed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS Krustpils iela 71E LV-1057 Rīga Latvia

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Estonia, Czech Republic, Italy, Portugal Urapidil Kalceks Austria Urapidil Kalceks 25 mg, 50 mg Injektions-/Infusionslösung Germany Urapidil Kalceks 25 mg, 50 mg Injektions-/Infusionslösung Spain Urapidil Kalceks 5 mg/ml solución inyectable y para perfusion France URAPIDIL KALCEKS 25 mg/5 ml, solution injectable/pour perfusion URAPIDIL KALCEKS 50 mg/10 ml, solution injectable/pour perfusion Hungary Urapidil Kalceks 25 mg, 50 mg oldatos injekció vagy infúzió Latvia Urapidil Kalceks 25 mg, 50 mg šķīdums injekcijām/infūzijām Netherlands Urapidil Kalceks 25 mg, 50 mg oplossing voor injectie/infusie Poland Urapidil KALCEKS Romania Urapidil Kalceks 25 mg, 50 mg soluție injectabilă/perfuzabilă Slovakia Urapidil Kalceks 25 mg, 50 mg injekčný/infúzny roztok

Date of Last Revision of the Package Leaflet: 09/2022

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Information Intended for Healthcare Professionals Only:

Dosage

Acute Conditions in Hypertension (e.g., Hypertensive Crisis), Severe to Very Severe Hypertension or Resistant Hypertension

• Intravenous Injection10-50 mg of urapidil is administered slowly - with constant blood pressure monitoring. A decrease in blood pressure can be expected within 5 minutes after injection. Depending on the response of blood pressure, the injection of urapidil can be repeated.
• Intravenous Infusion or Continuous Infusion Using an Infusion Pump

Intravenous infusion (by drip or infusion pump) is used to maintain blood pressure at the level achieved by injection of the product. To obtain instructions for preparing the diluted solution, see "Instructions for Use and Disposal" and "Preparation of the Diluted Solution" below. The maximum amount of urapidil is 4 mg per ml of infusion solution. Rate of AdministrationThe infusion rate depends on the individual blood pressure values of the patient. The initial infusion rate is: 2 mg/min. The degree of blood pressure reduction depends on the dose administered during the first 15 minutes. The desired blood pressure level can then be maintained with significantly lower doses. Maintenance dose: approximately 9 mg/hour, which corresponds to 250 mg of urapidil added to 500 ml of infusion solution, which corresponds to 1 mg = 44 drops = 2.2 ml. Controlled Reduction of Blood Pressure in Case of Increased Blood Pressure During and After SurgeryTo maintain the blood pressure level achieved by injection, a continuous infusion is used with an infusion pump or continuous intravenous infusion.

Scheme of Administration

Intravenous Injection 25 mg of urapidil (= 5 ml of solution for injection/infusion) If blood pressure reduction occurs after 2 minutes, blood pressure is stabilized at the level achieved by infusion. Initially, administer up to 6 mg over 1-2 minutes, then reduce the dose. If no change in blood pressure occurs after 2 minutes, administer 25 mg of urapidil (= 5 ml of solution for injection/infusion) by intravenous injection. If blood pressure reduction occurs after 2 minutes, blood pressure is stabilized at the level achieved by infusion. After 2 minutes, if no change in blood pressure occurs, administer 50 mg of urapidil (= 10 ml of solution for injection) by slow intravenous injection.

Special Patient Groups

In patients with liver and/or kidney disease, it may be necessary to reduce the dose of urapidil. In elderly patients, antihypertensive medications must be administered with special caution, initially in small doses, due to the changed sensitivity of these patients to medications from this group.

Children and Adolescents

The efficacy and safety of urapidil in children and adolescents have not been established. There are no available data.

Method of Administration

Intravenous administration. Urapidil KALCEKS is administered intravenously by injection or infusion, and the patient should be in a lying position. The dose is administered as a single or multiple injections, as well as a slow infusion. Injections may be combined (continued) with slow infusions. When acute parenteral therapy is overlapped with maintenance oral antihypertensive therapy, it is possible to switch to maintenance oral therapy. To prevent toxicological effects, treatment should not be used for more than 7 days, which also applies to parenteral antihypertensive therapy. In case of recurrence of hypertension, parenteral treatment can be repeated.

Incompatibilities

This medicinal product must not be mixed with alkaline solutions for injection or infusion, as they may become cloudy or flocculent due to the acidic properties of the solution. This medicinal product must not be mixed with other medicinal products except those listed below.

Instructions for Use and Disposal

For single use only. Use immediately after opening the ampoule. All unused remnants of the medicinal product or its waste should be disposed of. This medicinal product should be visually inspected before use. Only a clear and particle-free solution can be administered. Preparation of the diluted solution

• Intravenous Injection:add 250 mg of urapidil to 500 ml of one of the compatible infusion solutions (see below).
• Infusion Pump:draw 20 ml of solution for injection/infusion (= 100 mg of urapidil) into the infusion pump and dilute to a volume of 50 ml with a compatible infusion solution (see below).

It can be diluted with:

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

Instructions for opening the ampoule

• 1) Turn the ampoule with the colored point upwards. If there is a solution in the upper part of the ampoule, gently tap with your finger to move the entire solution to the lower part of the ampoule.
• 2) Use both hands to open the ampoule; holding the lower part of the ampoule in one hand, break the upper part of the ampoule in the direction of the colored point (see picture below).

Any unused remnants of the medicinal product or its waste should be disposed of in accordance with local regulations.