Urapidil kalceks

Patient Information Leaflet

Urapidil Kalceks, 25 mg, solution for injection/infusion
Urapidil Kalceks, 50 mg, solution for injection/infusion
Urapidilum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet Contents

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

1. What Urapidil Kalceks is and what it is used for

Urapidil Kalceks contains the active substance urapidil. Urapidil is a blood pressure-lowering medicine (antihypertensive) belonging to a group of medicines known as "alpha-blockers". This medicine acts on blood vessels (i.e. arteries and veins) and reduces blood pressure by decreasing vascular tone.

This medicine is used in adults:

• in emergency situations of high blood pressure (e.g. sudden, severe high blood pressure known as "hypertensive crisis");
• in the treatment of severe to very severe hypertension or in treatment-resistant hypertension;
• to reduce 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 medicine (listed in section 6);
• if the patient has aortic stenosis (narrowing of the main artery) or vascular abnormalities known as arteriovenous fistula (with the exception of arteriovenous fistula in dialysed patients);
• if the patient is breastfeeding.

Warnings and precautions
If blood pressure drops too quickly, it may cause slowing of the heartbeat or cardiac arrest.
Before taking this medicine, discuss the following with your doctor or nurse if any of the
following apply to the patient, as special caution is required:

• if the patient has had diarrhoea or vomiting (or other conditions causing reduced fluid volume in the body);
• in patients with heart failure due to mechanical damage, such as valve narrowing (aortic or mitral stenosis);
• in patients with pulmonary artery obstruction (pulmonary embolism);
• in patients with heart disorders caused by pericarditis (pericardial disease);
• in patients with liver function disorders;
• in patients with moderate to severe kidney function impairment;
• in elderly patients;
• in patients concurrently taking cimetidine (a drug that inhibits gastric acid production). If the patient is unsure whether any of the above apply, they should consult their doctor or nurse.

If the patient is undergoing cataract surgery (clouding of the lens), they should inform the
ophthalmologist before surgery that they are currently taking or have previously taken urapidil. This is because urapidil may cause complications during surgery, which can be prevented if the specialist is prepared in advance.
If another antihypertensive medicine has been administered before urapidil, the doctor will wait an appropriate amount of time for the previously administered medicine to take effect. The doctor will reduce the dose of urapidil. A too rapid decrease in blood pressure may lead to slowing or arrest of the heartbeat.
Children
This medicine must not be used in children and adolescents.
Urapididil Kalceks with other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Before using this medicine, inform your doctor or nurse if the patient is taking any of the following medicines, as they may interact with Urapidil Kalceks, altering the effect of the medicines or increasing the likelihood of adverse effects:

• alpha-blockers (used in the treatment of urinary disorders related to prostate disease);
• any medicines that lower blood pressure;
• cimetidine (used to inhibit gastric acid production);
• barbiturates (medicines used in the treatment of epilepsy).

Urapidil Kalceks and alcohol
Alcohol may enhance the effect of this medicine.
Pregnancy, breastfeeding and fertility
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.
There are insufficient data to assess the safety of urapidil use in pregnant women.
This medicine must not be used during pregnancy unless it is clinically necessary. If high blood pressure occurs during pregnancy and treatment with this medicine is required, blood pressure reduction should be gradual and always under medical supervision.
It is unknown whether the medicine passes into human milk. For safety reasons, this medicine must not be used during breastfeeding.
This medicine is not recommended for women of childbearing potential who are not using contraception.
Animal studies have shown that urapidil affects fertility. However, the significance of this effect in humans is unknown.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery, particularly at the start of treatment, when the dose is increased, when treatment is changed, or when combined with alcohol.
Urapidil Kalceks contains propylene glycol (E1520) and sodium
Propylene glycol:

• This medicine contains 500 mg of propylene glycol per 5 ml of solution and 1,000 mg of propylene glycol per 10 ml of solution, equivalent to 100 mg/ml.
• If the patient is pregnant or breastfeeding, this medicine should not be administered unless prescribed by a doctor. The doctor may perform additional monitoring during treatment with this medicine.
• If the patient has liver or kidney disease, this medicine should not be taken unless prescribed by a doctor. The doctor may perform additional monitoring during treatment with this medicine.
• Propylene glycol contained in this medicine may cause symptoms similar to those after alcohol consumption and may increase the likelihood of adverse effects. Sodium:
• The medicine contains less than 1 mmol (23 mg) of sodium per ml; therefore, the medicine is considered "sodium-free".

3. How to use Urapidil Kalceks

How to use the medicine

• This medicine will be administered by trained medical personnel.
• This medicine will be given as an intravenous injection or infusion. It may be administered as a single or repeated injections or as continuous infusions. Injections may be followed (continued) by continuous infusions.
• The patient should be lying down during administration of this medicine.
• Blood pressure will be continuously monitored during treatment.

Dosage
The doctor will decide the appropriate dose according to the patient's condition.

Hypertensive crisis and severe to very severe forms of arterial hypertension or treatment-resistant hypertension
Intravenous injection
Slow intravenous injection of 10–50 mg of urapidil is administered, with continuous monitoring of blood pressure. A reduction in blood pressure can be expected within 5 minutes after injection. Depending on the arterial pressure response, the urapidil injection may be repeated.

Intravenous infusion (by drip infusion or using an infusion pump)
For continuous intravenous infusion, 250 mg of urapidil is added to 500 ml of a compatible infusion solution (0.9% sodium chloride solution or 5% or 10% glucose solution).
When using an infusion pump, draw up 100 mg of urapidil into the infusion pump and dilute to a volume of 50 ml with a compatible infusion solution (see above) (maximum 4 mg of urapidil per ml of infusion solution).
Initial infusion rate is 2 mg/min. The maintenance dose averages 9 mg/hour. The extent of blood pressure reduction will be determined based on the dose administered within the first 15 minutes. The desired blood pressure level can then be maintained with significantly lower doses.

Reduction of high blood pressure during and/or after surgery
To maintain the blood pressure level achieved by injection, continuous infusion via an infusion pump or continuous intravenous infusion is used.

By intravenous injection
Initially, 25 mg of urapidil is administered. This dose should be repeated if an adequate reduction in blood pressure has not been achieved after 2 minutes. If blood pressure reduction remains insufficient 2 minutes after the second dose, 50 mg of urapidil should be administered.
If blood pressure reduction 2 minutes after administration of the dose is adequate, the patient will then receive a maintenance dose.

Intravenous infusion (by drip or infusion pump)
Initially, up to 6 mg is administered over 1–2 minutes. The dose is then reduced.

Special patient groups
Dose reduction may be necessary in patients with hepatic and/or renal impairment.
In elderly patients, this medicine must be administered with particular caution and initially in low doses due to altered sensitivity of these patients to medicines of this class.

Duration of treatment
The duration of treatment with this medicine should not exceed 7 days.

Use of a higher than recommended dose of Urapidil Kalceks
If too high a dose of this medicine is administered, symptoms such as dizziness, feeling of emptiness in the head or fainting upon standing, fatigue, and slowed reaction time may occur. In such a case, the patient should lie on their back with legs elevated. If symptoms do not resolve, the doctor or nurse should be informed immediately.

If you have any doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
In most cases, the adverse reactions listed below were related to too rapid a decrease in blood pressure. However, previous experience shows that even during slow infusion, these reactions subside within a few minutes. The doctor will decide whether to discontinue or continue treatment, depending on the severity of the adverse reactions.

Common (may occur in up to 1 in 10 patients)
Dizziness, headache, nausea.

Uncommon (may occur in up to 1 in 100 patients)
Sleep disturbances, 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, diarrhoea, dry mouth, sweating, fatigue, irregular heartbeat.

Rare (may occur in up to 1 in 1,000 patients)
Nasal mucosal congestion, allergic reactions (itching, skin redness, rash), prolonged and painful erection.

Very rare (may occur in up to 1 in 10,000 patients)
Restlessness, increased need to urinate, worsening of urinary incontinence, decreased platelet count (blood cells involved in blood clotting).

Frequency not known (frequency cannot be estimated from available data)
Urticaria, severe allergic reaction with swelling of the face, lips, tongue and throat.

Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or nurse. This includes any adverse reactions not listed in this leaflet.
Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Urapidil Kalceks

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicinal product.

After dilution:
Chemical and physical stability has been demonstrated for 50 hours at 25°C and at 2–8°C
after dilution in 9 mg/ml (0.9%) sodium chloride or 50 mg/ml (5%) glucose, or 100 mg/ml (10%)
glucose infusion solution.
From a microbiological standpoint, the diluted solution should be used immediately. If not used
immediately, the user is responsible for the storage conditions and duration prior to use, which
should generally not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution was carried
out under controlled and validated aseptic conditions.

Do not use this medicine after the expiry date stated on the outer carton after “Expiry date (EXP)”
and on the ampoule after “EXP”. The expiry date refers to the last day of the stated month.

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

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia

This medicinal product is authorised 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 perfusión
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

Information intended exclusively for medical professionals:

Dosage
Acute hypertensive conditions (e.g. hypertensive crisis), severe to very severe forms of arterial hypertension, or treatment-resistant hypertension

• Intravenous injection: Administer 10–50 mg of urapidil slowly by intravenous injection, with continuous monitoring of blood pressure. A reduction in blood pressure can be expected within 5 minutes after injection. Depending on the patient's blood pressure response, the urapidil injection may be repeated.
• Intravenous infusion or continuous infusion using an infusion pump

Intravenous infusion (via drip or infusion pump) is used to maintain the blood pressure achieved after the initial injection. For instructions on preparing the diluted solution, see “Instructions for use and disposal” and “Preparation of diluted solution” below.
The maximum concentration of urapidil is 4 mg per ml of infusion solution.
Infusion rate
The infusion rate depends on the individual patient's blood pressure values.
Initial infusion rate: 2 mg/min.
The degree of blood pressure reduction depends on the dose administered during the first 15 minutes. Subsequently, the target blood pressure may be maintained with significantly lower doses.
Maintenance dose: average 9 mg/h, corresponding to 250 mg of urapidil added to 500 ml of infusion solution, equivalent to 1 mg = 44 drops = 2.2 ml.
Controlled reduction of arterial blood pressure in cases of elevated blood pressure during and/or after surgical procedures
To maintain the blood pressure level achieved after the initial bolus injection, continuous infusion via an infusion pump or continuous drip infusion should be used.

Dosing regimen
Intravenous injection If reduction in arterial blood pressure occurs
25 mg urapidil within 2 min.
(Blood pressure stabilized)
No change in blood pressure Continue via
after 2 min.
infusion
Intravenous injection If reduction in arterial blood pressure occurs
25 mg urapidil within 2 min.
(=5 ml injection/infusion solution)
Initially administer
No change in blood pressure 6 mg over
after 2 min.
1–2 minutes, then
If reduction in arterial blood pressure occurs
Slow intravenous injection reduce dose
50 mg urapidil
within 2 min.
(=10 ml injection/infusion solution)

Special patient populations
In patients with hepatic and/or renal disease, a dose reduction of urapidil may be necessary.
In elderly patients, antihypertensive agents must be administered with particular caution and initially at low doses due to altered sensitivity to these drugs in this population.

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

Route of administration
Intravenous administration.
Urapidil KALCEKS is administered intravenously either as an injection or as an infusion. The patient should be in a lying position. The dose may be given as a single or multiple injections, as well as by slow infusion. Injections may subsequently be combined with a slow infusion.
When clinical improvement allows, parenteral therapy may be switched to maintenance treatment with oral antihypertensive agents.
To prevent potential toxicological effects, treatment should not last longer than 7 days, which also applies to parenteral antihypertensive therapy.
In case of recurrent hypertension, parenteral treatment may be repeated.

Incompatibilities
This medicinal product must not be mixed with alkaline injection or infusion solutions, as cloudiness or flocculation may occur due to the acidic nature 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. Any unused portions must be discarded.
This medicinal product should be inspected visually before use. Only clear, particle-free solutions should be administered.

Preparation of diluted solution

• Intravenous injection: Add 250 mg of urapidil to 500 ml of one of the compatible infusion solutions (see below).
• Infusion pump: Withdraw 20 ml of the injection/infusion solution (= 100 mg urapidil) into an infusion pump and dilute to a final volume of 50 ml with a compatible infusion solution (see below).

Compatible diluents include:

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

Instructions for opening the ampoule

1. Turn the ampoule with the coloured dot facing upwards. If solution is present in the upper part of the ampoule, gently tap the ampoule with the finger so that the solution flows down into the lower part.
2. Use both hands to open the ampoule; hold the lower part of the ampoule in one hand and snap off the top part in the direction away from the coloured dot (see image below).

Any unused portions or waste material of the medicinal product must be disposed of in accordance with local regulations.