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 this medicine is administered, because it contains
important information for you.

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

Table of contents

1. What Urapidil Kalceks is and what it is used for
2. What you need to know before you are given Urapidil Kalceks
3. How Urapidil Kalceks is given
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 an antihypertensive medicine that belongs to a group of medicines called alpha-adrenolytics. It acts on blood vessels (i.e. arteries and veins) and lowers blood pressure by reducing vascular resistance.
This medicine is used in adults:

• in situations of acute high blood pressure (e.g. sudden, severe high blood pressure known as "hypertensive crisis");
• in the treatment of severe to very severe forms of arterial 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 narrowing of the main artery (aortic stenosis) or blood vessel abnormalities known as "vascular shunt" (except for arteriovenous fistula in dialysed patients);
• if the patient is breastfeeding.

Warnings and precautions
If blood pressure drops too quickly, slowing of the heartbeat or cardiac arrest may occur.
Before taking this medicine, discuss with your doctor or nurse if any of the following apply to you, 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, e.g. heart valve stenosis (aortic or mitral valve stenosis);
• in patients with pulmonary artery obstruction (pulmonary embolism);
• in patients with heart disorders caused by inflammation of the pericardium (pericardial disease);
• in patients with impaired liver function;
• in patients with moderate to severe kidney dysfunction;
• in elderly patients;
• in patients concurrently using 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 or have previously used urapidil. This is because urapidil may cause complications during surgery, which can be prevented if the specialist is adequately prepared.
If another antihypertensive medicine has been administered before urapidil, the doctor will wait an appropriate amount of time to allow the previous 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.

Urapidil 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 they plan 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-adrenolytics (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 to treat 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 absolutely necessary due to the woman's clinical condition. If high blood pressure occurs during pregnancy and treatment with this medicine is required, blood pressure reduction should be gradual and always supervised by a doctor.
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 beginning 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 solution and 1,000 mg of propylene glycol per 10 ml 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.
• If the patient has liver or kidney disease, they should not take this medicine unless prescribed by a doctor. The doctor may perform additional monitoring during treatment.
• The propylene glycol contained in this medicine may cause symptoms similar to those after alcohol consumption and may increase the risk 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 is given as an intravenous injection or intravenous infusion. It may be administered as single or repeated injections or as continuous infusions. Injections may be followed (continued) by continuous infusions.
• During administration of this medicine, the patient should remain in a lying position.
• Blood pressure will be continuously monitored throughout treatment.

Dosage
The physician will determine the appropriate dose depending on the patient's condition.

Hypertensive crisis and severe to very severe arterial hypertension or treatment-resistant hypertension

Intravenous injection
Slow intravenous injection of 10–50 mg of urapidil is given, 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 should be 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).
The 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 during 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 may 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 will be administered.
If sufficient blood pressure reduction is achieved 2 minutes after administration, 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
In patients with hepatic and/or renal impairment, dose reduction may be necessary.
In elderly patients, this medicine must be administered with particular caution and initially in small doses due to altered sensitivity of these patients to medicines in this class.

Duration of treatment
Treatment with this medicine should not last longer than 7 days.

Use of more than the 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 cases, the patient should lie flat on their back with legs elevated. If symptoms do not resolve, the physician or nurse should be notified immediately.
If you have any questions regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In most cases, the adverse reactions listed below were related to too rapid
reduction of blood pressure; however, previous experience shows that even during
slow infusion they resolve 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 no more than 1 in 10 patients)
Dizziness, headache, nausea.
Uncommon (may occur in no more than 1 in 100 patients)
Sleep disturbances, palpitations, decreased or increased heart rate, feeling of pressure
or pain behind the breastbone (as in angina pectoris), difficulty breathing, drop in
arterial blood pressure when standing up from sitting or lying position (orthostatic
hypotension), vomiting, diarrhoea, dry mouth, sweating, fatigue, irregular heartbeat.
Rare (may occur in no more than 1 in 1,000 patients)
Nasal mucosal congestion, allergic reactions (itching, redness of the skin, rash),
prolonged and painful erection.
Very rare (may occur in no more than 1 in 10,000 patients)
Anxiety, increased need to urinate, worsening of urinary incontinence, decreased platelet count (blood cells involved in the blood clotting process).
Frequency not known (frequency cannot be estimated from the available data)
Urticaria, severe allergic reaction with swelling of the face, lips, tongue and throat.
Reporting of adverse reactions
If any adverse reactions occur, you should inform your doctor or nurse.
This applies to any adverse reactions not listed in this leaflet.
Adverse reactions may also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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
Adverse reactions may also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Urapidil Kalceks

The medicine should be stored out of the sight and reach of children.
There are no special requirements for storage of 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 point of view, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage time and conditions prior to use, which generally should 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 carton and on the ampoule after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 concentrated, disodium 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). 5 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 following names in the European Economic Area countries:
Estonia, Czech Republic, Italy, Portugal: Urapidil Kalceks
Austria: Urapidil Kalceks 25 mg, 50 mg Injektions-/Infusionslösung
Germany: Urapidil Ethypharm 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 healthcare professionals:

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

• Intravenous injection: Slowly administer 10–50 mg of urapidil, 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 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. Afterwards, the target blood pressure can be maintained with significantly lower doses.
Maintenance dose: average 9 mg/h, corresponding to 250 mg urapidil added to 500 ml of infusion solution, which equals 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 by injection, continuous infusion via an infusion pump or continuous drip infusion is used.
Dosing regimen
Intravenous injection If reduction of arterial
25 mg urapidil pressure occurs
(=5 ml of injection/infusion solution) within 2 min.
Blood pressure
stabilized
no change in blood pressure
after 2 min.
continue via
infusion
Intravenous injection If reduction of arterial
25 mg urapidil pressure occurs
(= 5 ml of injection/infusion solution) within 2 min.
Initially administer
no change in blood pressure
6 mg over
after 2 min.
1–2 minutes,
then reduce dose
If reduction of arterial
Slow intravenous injection pressure occurs
50 mg urapidil
within 2 min.
(= 10 ml of injection/infusion solution)

Special patient groups
In patients with hepatic and/or renal disease, a reduction in the dose of urapidil may be necessary.
In elderly patients, antihypertensive drugs must be administered with particular caution and initially in small doses due to altered sensitivity to these drugs.
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 followed by slow intravenous infusion.
When transitioning from acute parenteral therapy, switching to maintenance therapy with oral antihypertensive agents is possible.
To prevent potential toxicological effects, treatment should not be continued for longer than 7 days—this 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 prior to use. Only clear, particle-free solutions should be administered.

Preparation of diluted solution

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

Compatible diluents:

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

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 with a finger to ensure all solution moves to the lower part.
2. Use both hands to open the ampoule: hold the lower part of the ampoule in one hand and with the other hand, snap off the top part away from the coloured dot (see image below).

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