Runrapiq

Leaflet attached to the packaging: patient information

Runrapiq, 300 mg, powder for solution for infusion

Landiolol hydrochloride

Read the leaflet carefully before receiving the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

The full name of the medicine is Runrapiq, 300 mg, powder for solution for infusion. In this leaflet, a shorter name is used: Runrapiq.

Table of contents of the leaflet

• 1. What is Runrapiq and what is it used for
• 2. Important information before receiving Runrapiq
• 3. How to administer Runrapiq
• 4. Possible side effects
• 5. How to store Runrapiq
• 6. Contents of the pack and other information

1. What is Runrapiq and what is it used for

The active substance of Runrapiq is landiolol hydrochloride, which belongs to a group of medicines called beta-adrenergic blockers. The action of the medicine is to change an irregular or rapid heartbeat to a normal heartbeat. This medicine is used in adults to treat heart rhythm disorders when the heart beats too fast. It is used during or immediately after surgical operations or in other situations where heart rate control is required.

2. Important information before receiving Runrapiq

The doctor will NOT administer Runrapiq:

• if the patient is allergic to landiolol or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a very slow heartbeat (less than 50 beats per minute).
• if the patient has a fast or alternating fast and slow heartbeat (a condition called "sick sinus syndrome").
• if the patient has a condition called "severe heart block". Heart block is a condition where the electrical impulses that control the heartbeat are disrupted.
• if the patient has disorders of blood flow to the heart (so-called "cardiogenic shock").
• if the patient has very low blood pressure.
• if the patient has severe symptoms of heart failure.
• if the patient has high blood pressure in the lungs (pulmonary hypertension).
• if the patient has an untreated adrenal gland disease called pheochromocytoma. Pheochromocytoma is a tumor that develops in the adrenal glands and can cause a sudden increase in blood pressure, severe headache, sweating, and rapid heartbeat.
• if the patient has asthma symptoms that worsen rapidly.
• if the patient has a very high level of acids in the body (severe metabolic acidosis) that cannot be corrected.

Runrapiq must not be used if any of the above situations apply to the patient. If the patient is unsure whether any of these situations apply to them, they should discuss this with their doctor or nurse before taking the medicine.

Warnings and precautions

• Before receiving Runrapiq, discuss it with your doctor or nurse.
• Runrapiq is a powder and must be dissolved by a doctor or nurse before administration.
• Heart rate, blood pressure, and electrical activity of the heart are usually continuously monitored during treatment with this medicine.

The doctor will exercise particular caution when administering this medicine:

• if the patient has diabetes or low blood sugar levels. Landiolol may mask the symptoms of low blood sugar.
• if the patient has low blood pressure.
• if the patient has a condition called "pre-excitation syndrome" in combination with an irregular and rapid heartbeat (atrial fibrillation).
• if the patient has disorders of electrical impulse conduction that control the heartbeat (heart block).
• if the patient has conduction disorders in the heart and is receiving verapamil or diltiazem.
• if the patient has a particular type of chest pain (angina pectoris) called "Prinzmetal's angina".
• if the patient has or has had heart function disorders (such as congestive heart failure). The doctor will closely monitor the patient for any cardiac symptoms. If necessary, the doctor will discontinue treatment, reduce the dose of the medicine, or initiate special treatment.
• if the patient has heart rhythm disorders called supraventricular arrhythmias and: - if the patient has other heart diseases or - the patient is taking other heart medicines.
• if the patient has kidney disease.
• if the patient has an adrenal gland disease called pheochromocytoma that has been treated with alpha-blocker medicines.
• if the patient has respiratory tract narrowing or wheezing, such as in asthma.
• if the patient has circulation disorders, such as Raynaud's disease or pain, fatigue, and sometimes burning pain in the legs.
• if the patient has any allergies or risk of anaphylactic reactions (severe allergic reactions). Runrapiq may exacerbate allergies and make them more difficult to treat.

If any of the above situations apply to the patient (or the patient has doubts), they should discuss this with their doctor or nurse before taking the medicine.

Runrapiq and 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. This includes medicines that are available without a prescription, including herbal medicines and natural products. The doctor will check if other medicines the patient is taking may change the effect of Runrapiq. In particular, inform the doctor or nurse if the patient is taking any of the following medicines:

• Medicines used to treat heart rhythm disorders (e.g., diltiazem, verapamil, propafenone, dizopiramide, amiodarone, digoxin, digitalis glycosides) and high blood pressure (e.g., nifedipine).
• Medicines used to treat diabetes, including insulin and oral medicines.
• Medicines usually used during surgery to relax muscles (e.g., suxamethonium) or medicines used to reverse the effect of muscle relaxants, called cholinesterase inhibitors (e.g., neostigmine, distigmine, edrophonium). The doctor will exercise particular caution when administering Runrapiq during surgery, when the patient is receiving anesthetics and other medicines.
• Medicines known as ganglionic blockers (e.g., trimethaphan).
• Painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs).
• Floktafenine, a painkiller.
• Amisulpride, a medicine used to treat mental disorders.
• Tricyclic antidepressants (e.g., imipramine and amitriptyline).
• Barbiturates (e.g., phenobarbital used to treat epilepsy).
• Phenothiazines (e.g., chlorpromazine used to treat mental disorders).
• Medicines used to treat asthma.
• Medicines used to treat colds or nasal congestion, known as nasal decongestants.
• Medicines that may lower blood pressure (e.g., reserpine and clonidine).
• Adrenaline, used to treat allergic reactions.
• Heparin, used to thin the blood.

In case of doubts about whether any of the above situations apply to the patient, discuss this with the doctor or nurse before taking Runrapiq.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Data on the use of Runrapiq during pregnancy are limited. Due to limited experience, it is recommended to avoid using landiolol during pregnancy. If the patient is breastfeeding, they should inform their doctor. Runrapiq may pass into breast milk, so it should not be administered during breastfeeding.

3. How to administer Runrapiq

• Runrapiq is a powder and must be dissolved by a doctor or nurse before administration. The medicine is administered by infusion through a needle inserted into a vein. The dose should be chosen individually. An initial dose may be given, followed by a maintenance dose. The doctor will determine the dosing schedule and adjust the dose according to needs. The duration of treatment depends on the effect and possible side effects. The doctor will determine the duration of treatment. Runrapiq is usually not administered for more than 24 hours.
• Heart rate, blood pressure, and electrical activity of the heart are monitored when the patient receives Runrapiq.
• After achieving a stable condition, the patient may receive another heart medicine while the dose of Runrapiq is being reduced.

Dose adjustment of this medicine is usually not necessary in elderly patients. If the patient has kidney function disorders, the doctor will take appropriate precautions.

Liver function disorders

If the patient has liver function disorders, the doctor will start treatment with a lower dose.

Use in children and adolescents

Experience with the use of Runrapiq in children and adolescents is limited. The doctor will decide whether to use Runrapiq.

Administration of a higher dose of Runrapiq than recommended

If the patient thinks they have received too much Runrapiq, they should immediately inform their doctor or nurse. The doctor will take appropriate measures (the infusion may be stopped immediately, and the patient may receive supportive treatment). If the patient has received too much of the medicine, the following symptoms may occur:

• Significant drop in blood pressure (dizziness or fainting may occur)
• Very slow heartbeat
• Weak heart function
• Cardiogenic shock
• Breathing disorders
• Loss of consciousness, including coma
• Seizures (convulsions)
• Nausea
• Vomiting
• Low blood sugar levels
• High potassium levels in the blood (hyperkalemia)

Discontinuation of Runrapiq

Sudden discontinuation of Runrapiq usually does not cause a recurrence of rapid heartbeat symptoms (tachycardia). The doctor will closely monitor the patient if the administration of this medicine is discontinued. In case of any further doubts about the use of this medicine, consult the doctor or nurse.

4. Possible side effects

Like all medicines, Runrapiq can cause side effects, although not everybody gets them. Most side effects disappear within 30 minutes of stopping the administration of Runrapiq. The patient should immediately inform their doctor or nurse if they notice any of the following side effects, which may be serious. It may be necessary to stop the infusion if the doctor notices any serious changes in:

• heart rate
• blood pressure
• electrical activity of the heart

Common (may affect up to 1 in 10 people):

• Slow heartbeat
• Low blood pressure

Uncommon (may affect up to 1 in 100 people):

• Lung infection (pneumonia)
• Low sodium levels in the blood (hyponatremia)
• Reduced blood flow to the brain, headaches
• Disorders of normal blood circulation (sudden cardiac arrest), rapid heartbeat
• High blood pressure
• Fluid accumulation in the lungs
• Vomiting, nausea
• Liver disease
• Changes in blood test results
• Abnormal number of blood cells responsible for blood clotting (platelets)
• Abnormally high levels of bilirubin (a pigment produced by the breakdown of red blood cells) in the blood

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the chest tissue
• High blood sugar levels
• Stroke, seizures
• Heart attack, heart rhythm disorders, weak heart function
• Shock, heat stroke
• Breathing disorders (lung disease characterized by narrowing of the airways, making breathing difficult), lung disease, abnormally low oxygen levels in the blood
• Discomfort in the abdominal cavity, mouth discharge, bad breath
• Redness of the skin, cold sweats
• Muscle spasms
• Kidney failure, kidney damage, decreased urine output
• Fever, chills, feeling of discomfort in the chest, pain at the injection site
• Increased pressure in the pulmonary vessels
• Presence of sugar (glucose) in the urine
• Abnormal urine test results (protein in the urine, increased urea content in the urine)
• Abnormal heart test results (ECG, ultrasound)

Frequency not known (cannot be estimated from the available data):

• Skin changes at the injection site, feeling of pressure at the injection site.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 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, more information can be collected on the safety of the medicine.

5. How to store Runrapiq

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the month stated.
• There are no special precautions for storing the medicine.
• Runrapiq must be dissolved before use. The diluted medicine is stable for 24 hours at 25°C. However, the medicine should be used immediately after dilution.
• Do not use this medicine if particles or discoloration of the solution are observed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Runrapiq contains

The active substance is landiolol hydrochloride. The vial contains 300 mg of landiolol hydrochloride (in powder form), which corresponds to 280 mg of landiolol. After dissolution, 1 ml of the solution contains 6 mg of landiolol hydrochloride. The other ingredients are mannitol and sodium hydroxide (to ensure the correct pH).

What Runrapiq looks like and contents of the pack

Runrapiq is a white or off-white powder for solution for infusion. The pack size is one 50 ml vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Amomed Pharma GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria. For more information, contact the representative of the marketing authorization holder: AOP Orphan Pharmaceuticals Poland Sp. z o.o., ul. Olkuska 7, 02-604 Warsaw, Poland, Tel: +48 22 542 81 80.

Manufacturer

AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Rapibloc 300 mg Pulver zur Herstellung einer Infusionslösung, Bulgaria: Rapibloc 300 mg прах за инфузионен разтвор, Croatia: Rapibloc 300 mg prašak za otopinu za infuziju, Cyprus: Rapibloc 300 mg κόνις για διάλυμα προς έγχυση, Czech Republic: Rapibloc 300 mg prášek pro infuzní roztok, Denmark: Rapibloc 300 mg pulver til infusionsvæske, opløsning, Estonia: Raploc 300 mg infusioonilahuse pulber, Germany: Rapibloc 300 mg Pulver zur Herstellung einer Infusionslösung, Greece: Rapibloc 300 mg κόνις για διάλυμα προς έγχυση, Finland: Rapibloc 300 mg infuusiokuiva-aine, liuosta varten, France: Rapibloc 300 mg poudre pour solution pour perfusion, Hungary: Rapibloc 300 mg por oldatos infúzióhoz, Italy: Landiobloc 300 mg polvere per soluzione per infusione, Lithuania: Raploc 300 mg milteliai infuziniam tirpalui, Latvia: Raploc 300 mg pulveris infūziju šķīduma pagatavošanai, Netherlands: Rapibloc 300 mg poeder voor oplossing voor infusie, Norway: Raploc 300 mg pulver til infusjonsvæske, oppløsning, Romania: Rapibloc 300 mg pulbere pentru soluţie perfuzabilă, Slovakia: Rapibloc 300 mg prášok na infúzny roztok, Slovenia: Rapibloc 300 mg prašek za raztopino za infundiranje, Sweden: Rapibloc 300 mg pulver till infusionsvätska, lösning.

Date of last revision of the leaflet:2024-02-23

Information intended for healthcare professionals only:

This section contains practical information on administration. Please read the "Summary of Product Characteristics" to get full information on dosing and method of administration, contraindications, warnings, etc. Landiolol is intended for intravenous use in controlled conditions. Landiolol should only be administered by qualified medical personnel. The dosage of landiolol should be adjusted individually. Runrapiq must not be administered without prior dissolution. Dissolve 1 vial in 50 ml of one of the following solutions: roztwór 0,9% NaCl (9 mg/ml), roztwór 5% glukozy (50 mg/ml), roztwór Ringera, mleczanowy roztwór Ringera. The white or off-white powder dissolves completely after dissolution. Gently mix until a clear solution is obtained. The dissolved solution should be inspected for visible particles and discoloration. Only clear and colorless solutions should be used.

Infusion is usually started at a rate of 10-40 micrograms/kg/min, which allows the heart rate to slow down within 10-20 minutes. If rapid control of heart rate is required (within 2 to 4 minutes), an optional loading dose of 100 micrograms/kg/min may be considered for 1 minute, followed by continuous intravenous infusion at a dose of 10-40 micrograms/kg/min. In patients with heart disorders and septic shock, smaller initial doses should be used. Dosing instructions are provided in the section "Special patient populations" and in the integrated dosing schedule. Maximum dose: The maintenance dose may be increased to 80 micrograms/kg/min for a limited period (see section 5.2 of the SmPC), if the patient's cardiovascular system requires an increase in dose and can tolerate it, and if the maximum daily dose is not exceeded. The maximum recommended daily dose of landiolol hydrochloride is 57.6 mg/kg/day (e.g., infusion at a dose of 40 micrograms/kg/min for 24 hours). Experience with the use of landiolol infusion at doses >10 micrograms/kg/min for more than 24 hours is limited. Formula for continuous intravenous infusion: micrograms/kg/min to ml/hour (Runrapiq 300 mg/50 ml = 6 mg/ml): Target dose (micrograms/kg/min) x body weight (kg) / 100 = infusion rate (ml/hour). Conversion table (example):

Optional administration of a bolus to hemodynamically stable patients: Formula for conversion from 100 micrograms/kg/min to ml/hour (Runrapiq 300 mg/50 ml = 6 mg/ml): Infusion rate of the loading dose (ml/hour) for 1 minute = body weight (kg). (Example: infusion rate of the loading dose 70 ml/hour for 1 minute for a patient with a body weight of 70 kg). If side effects occur, the dose of landiolol should be reduced or the infusion stopped, and the patient should receive appropriate medical care if necessary. If the patient has received too much of the medicine, the following symptoms may occur: severe hypotension, severe bradycardia, atrioventricular block, heart failure, cardiogenic shock, sudden cardiac arrest, bronchospasm, respiratory failure, loss of consciousness, including coma, seizures, nausea, vomiting, hypoglycemia, and hyperkalemia. If an overdose occurs, landiolol administration should be stopped immediately. Switching to an alternative medicine: After achieving adequate control of heart rate and stabilization of the clinical condition, it is possible to switch to alternative medicines (such as oral antiarrhythmic medicines). When landiolol is to be replaced with an alternative medicine, the doctor should carefully review the information on the alternative medicine and its dosing. When replacing landiolol with an alternative medicinal product, the dose of landiolol can be reduced as follows:

• Within the first hour after administration of the first dose of the alternative medicine, the infusion rate of landiolol should be reduced by half (50%).

After administration of the second dose of the alternative medicine, the patient's response should be monitored, and if satisfactory control is maintained for at least one hour, the infusion of landiolol can be discontinued.

Special patient populations: Patients aged 65 and over: No dose adjustment is necessary. Patients with renal impairment: No dose adjustment is necessary. Patients with hepatic impairment: Data on the treatment of patients with hepatic impairment are limited. In patients with hepatic impairment of any degree, cautious dosing is recommended, starting with the lowest dose. Heart disorders: To achieve control of heart rate in patients with left ventricular function disorders (LVEF <40%, CI <2.5 l/min/m2, NYHA class 3-4), e.g., after cardiac surgery, during ischemia, or in septic conditions, smaller initial doses were used, starting from 1 microgram/kg/min, and increased gradually under close control of blood pressure to 10 micrograms/kg/min. Further dose increases can be considered under close control of hemodynamic parameters if necessary and well tolerated by the patient, taking into account the patient's cardiovascular system. Septic shock: In patients with septic shock, smaller doses were used to control heart rate, from 1 microgram/kg/min to a maximum of 40 micrograms/kg/min. The dose was increased in increments of 1 microgram/kg/min with a minimum interval of 20 minutes between consecutive doses under close control of blood pressure. Children and adolescents: The safety and efficacy of landiolol in children under 18 years of age have not been established. Method of administration: Runrapiq must be dissolved before administration and used immediately after opening. Do not mix Runrapiq with other medicinal products, except those mentioned in section 6.6 of the SmPC. Landiolol should be administered intravenously using a central or peripheral venous catheter and should not be administered through the same intravenous catheter as other medicines. Unlike other beta-adrenergic blockers, landiolol does not cause withdrawal tachycardia after sudden discontinuation of administration after 24 hours of continuous infusion. Nevertheless, patients should be closely monitored when the administration of landiolol is discontinued. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC. Severe bradycardia (less than 50 beats per minute). Sick sinus syndrome. Severe conduction disorders in the atrioventricular node (without a pacemaker): second- or third-degree atrioventricular block. Cardiogenic shock. Severe hypotension. Decompensated heart failure, unless related to arrhythmias. Pulmonary hypertension. Untreated pheochromocytoma. Acute asthma attack. Severe, uncorrectable metabolic acidosis.