Runrapiq

Package leaflet: Information for the patient

Runrapiq, 300 mg, powder for solution for infusion
landiololi hydrochloridum
Please read all of this leaflet carefully before receiving this medicine, because it contains
important information for the patient.

• 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 get any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

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

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

1. What Runrapiq is and what it is used for

The active substance in Runrapiq is landiolol hydrochloride, which belongs to a group of medicines called beta-
blockers. This medicine works by changing irregular or rapid heartbeats into a normal heart rhythm.
This medicine is used in adults to treat heart rhythm disorders when the heart beats too fast.
It is used during or immediately after surgery or in other situations where control of heart rate 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).
• the patient has a very slow heartbeat (less than 50 beats per minute).
• the patient has fast or alternating fast and slow heartbeat (a disorder called "sick sinus syndrome").
• the patient has a condition known as "severe heart block". Heart block is a disorder of electrical impulse conduction that controls the heart rhythm.
• the patient has impaired blood flow to the heart (so-called "cardiogenic shock").
• the patient has very low blood pressure.
• the patient has severe symptoms of heart failure.
• the patient has high blood pressure in the lungs (pulmonary hypertension).
• the patient has untreated phaeochromocytoma (a tumour of the adrenal gland). Phaeochromocytoma develops in the adrenal glands and may cause sudden increases in blood pressure, severe headache, sweating, and rapid heartbeat.
• the patient has rapidly worsening asthma symptoms.
• the patient has severe metabolic acidosis (a high level of acids in the body) that cannot be corrected.

Runrapiq must not be used if any of the above conditions apply to the patient. If the patient is
unsure whether any of these conditions apply, discuss this with the doctor or nurse before receiving the
medicine.
Warnings and precautions

• Before receiving Runrapiq, discuss this with the doctor or nurse.
• Runrapiq is a powder and must be dissolved by a doctor or nurse before administration.
• Heart rate, blood pressure, and the heart's electrical activity 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 symptoms of low blood sugar.
• if the patient has low blood pressure.
• if the patient has a disorder called "pre-excitation syndrome" in combination with irregular and rapid heart rhythm (atrial fibrillation).
• if the patient has disorders of electrical impulse conduction that control heart rhythm (heart block).
• if the patient has disorders of electrical impulse conduction in the heart and is receiving verapamil or diltiazem.
• if the patient has a specific type of angina (chest pain) 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 may discontinue treatment, reduce the dose, or initiate special treatment.
• if the patient has supraventricular arrhythmias (heart rhythm disorders) and:
• if the patient has other heart diseases or
• the patient is taking other heart medications.
• if the patient has kidney disease.
• if the patient has phaeochromocytoma (a tumour of the adrenal gland) treated with alpha-blocking drugs.
• if the patient has airway narrowing or wheezing, as in asthma.
• if the patient has circulatory disorders such as pale fingers (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 worsen allergies and make them more difficult to treat.

If any of the above conditions apply to the patient (or if the patient has any doubts),
talk to the doctor or nurse before using the medicine.
Runrapiq and other medicines
Inform the 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 available without a prescription,
including herbal medicines and natural products. The doctor will check whether other medicines the patient
is taking could alter 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, disopyramide, amiodarone, digoxin, cardiac glycosides) and high blood pressure (e.g. nifedipine).
• Medicines used to treat diabetes, including insulin and oral antidiabetic drugs.
• Medicines usually used during surgery to relax muscles (e.g. suxamethonium) or medicines used to reverse the effect of muscle relaxants, known as cholinesterase inhibitors (e.g. neostigmine, distigmine, edrophonium). The doctor will exercise particular caution when administering Runrapiq during surgery when the patient is receiving anaesthetics and other medicines.
• Medicines known as ganglion-blocking agents (e.g. trimethaphan).
• Pain-relieving medicines such as non-steroidal anti-inflammatory drugs (NSAIDs).
• Floctafennine, which is a pain-relieving medicine.
• Amisulpride, a medicine used to treat psychiatric disorders.
• Tricyclic antidepressants (e.g. imipramine and amitriptyline).
• Barbiturates (e.g. phenobarbital used to treat epilepsy).
• Phenothiazines (e.g. chlorpromazine, used to treat psychiatric 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, which is used to treat allergic reactions.
• Heparin, which is used to thin the blood.

If in doubt whether any of the above conditions apply to the patient, talk to the doctor or nurse before
using Runrapiq.
Pregnancy and breastfeeding
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.
Data on the use of Runrapiq during pregnancy are limited. Due to limited experience, it is recommended to avoid using landiolol during pregnancy.
Inform the doctor if the patient is breastfeeding. Runrapiq may pass into human milk; therefore, 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 given as an intravenous infusion through a needle placed in the patient's vein.
• The dose should be individually adjusted. An initial dose may be given, followed by a maintenance dose. The doctor will determine the dosing regimen and adjust the dose according to individual needs.
• The duration of treatment depends on the effect and possible adverse reactions. The doctor will decide how long the treatment should last. Runrapiq is usually administered for no longer than 24 hours.
• Heart rate, blood pressure, and electrical activity of the heart are monitored while the patient is receiving Runrapiq.
• Once a stable condition is achieved, the patient may receive another heart medication while the dose of Runrapiq is being tapered down.

Dose adjustment of this medicine is usually not required in elderly patients.
If the patient has renal impairment, the doctor will take appropriate precautions.
Hepatic impairment
If the patient has hepatic impairment, the doctor will initiate 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 treatment.
Administration of a higher than recommended dose of Runrapiq
If the patient feels that they have received too high a dose of Runrapiq, the doctor or nurse should be informed immediately.
The doctor will take appropriate measures (administration of the medicine may be immediately stopped, and the patient may receive supportive treatment).
If the patient has received too high a dose of the medicine, the following symptoms may occur:

• Significant drop in blood pressure (dizziness or feeling faint may occur)
• Very slow heartbeat
• Impaired heart function
• Shock due to impaired heart function
• Breathing difficulties
• Loss of consciousness, including coma
• Seizures (convulsions)
• Nausea
• Vomiting
• Low blood sugar levels
• High blood potassium levels (hyperkalemia)

Discontinuation of Runrapiq
Sudden discontinuation of Runrapiq usually does not cause recurrence of rapid heart rate symptoms (tachycardia). The doctor will closely monitor the patient if treatment with this medicine is stopped.
If there are any further questions regarding the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions resolve within 30 minutes after completion of Runrapiq infusion.
Patients should immediately inform their doctor or nurse if any of the following adverse reactions occur, as they may be serious.
The infusion may need to be discontinued if the doctor observes any serious changes in:

• Heart rhythm
• Blood pressure
• Electrical activity of the heart

Common (may occur in up to 1 in 10 patients):

• Slow heartbeat
• Low blood pressure

Uncommon (may occur in up to 1 in 100 patients):

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

Rare (may occur in up to 1 in 1,000 patients):

• Inflammation of the tissues of the chest cavity
• High blood sugar levels
• Stroke, seizures
• Myocardial infarction (heart attack), heart rhythm disorders, impaired heart function
• Shock, hot flushes
• Breathing disorders (lung disease associated with narrowing of the airways, making breathing difficult), lung disease, abnormally low oxygen levels in the blood
• Abdominal discomfort, oral discharge, bad breath
• Skin redness, cold sweats
• Muscle spasms
• Kidney failure, kidney damage, reduced urine volume
• Fever, chills, feeling of discomfort in the chest, injection site pain
• Increased pressure in the pulmonary vessels
• Presence of sugar (glucose) in urine
• Abnormal urine test results (protein in urine, increased urine urea content)
• Abnormal heart test results (ECG, echocardiography)

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

• Skin changes at the injection site, sensation of pressure at the injection site

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

5. How to store Runrapiq

• Store the vial in the outer packaging to protect from light.
• Keep the medicine out of the 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 stated month.
• There are no special requirements for storage temperature.
• Runrapiq must be reconstituted before use. The reconstituted solution is stable for 24 hours at 25°C. However, the medicine should be used immediately after reconstitution.
• Do not use this medicine if particles or discoloration of the solution are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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), equivalent to 280 mg of landiolol. After reconstitution, 1 ml of solution contains 6 mg of landiolol
hydrochloride.
The other components are: mannitol and sodium hydroxide (to adjust pH).

What Runrapiq looks like and contents of the pack
Runrapiq is a white or off-white powder for solution for infusion.
Pack size: one 50 ml vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amomed Pharma GmbH
Leopold-Ungar-Platz 2,
1190 Vienna,
Austria
For further information, please contact the representative of the Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals Poland Sp. z o.o.
ul. Puławska 145
02-715 Warsaw, Poland
Tel: +48 22 245 43 95

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

This medicinal product is authorised in the European Economic Area countries 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

Information intended exclusively for healthcare professionals:

This section contains practical administration information. Please refer to the "Summary of Product Characteristics" for complete information on dosage and administration methods, contraindications, warnings, etc.

Landiolol is intended for intravenous use under controlled conditions. Landiolol should only be administered by qualified medical personnel. Landiolol dosage must be individually adjusted.

Runrapiq must not be administered without prior dilution.

Dissolve 1 vial in 50 mL of one of the following solutions:

• 0.9% NaCl solution (9 mg/mL)
• 5% glucose solution (50 mg/mL)
• Ringer's solution
• Ringer's lactate solution

White or almost white powder dissolves completely upon reconstitution. Gently mix until a clear solution is obtained. The reconstituted solution should be inspected visually for particulate matter and discoloration. Only clear and colorless solutions should be used.

Infusion is usually initiated at a rate of 10–40 micrograms/kg body weight/min, allowing heart rate reduction within 10–20 minutes.

If rapid heart rate reduction is required (within 2 to 4 minutes), consider administering an optional loading dose of 100 micrograms/kg body weight/min for 1 minute, followed by continuous intravenous infusion at 10–40 micrograms/kg body weight/min.

Lower initial doses should be used in patients with cardiac disorders and in septic shock.

Dosage instructions are provided in the section "Special patient populations" and in the integrated dosing scheme.

Maximum dose: The maintenance dose may be increased up to 80 micrograms/kg body weight/min for a limited period (see section 5.2 SmPC), if the patient's cardiovascular status requires and tolerates such an increase, and if the maximum daily dose is not exceeded. The maximum recommended daily dose of landiolol hydrochloride is 57.6 mg/kg body weight/day (e.g., infusion at 40 micrograms/kg body weight/min administered over 24 hours).

Experience with landiolol infusions at doses >10 micrograms/kg body weight/min administered for longer than 24 hours is limited.

Conversion formula for continuous intravenous infusion: micrograms/kg body weight/min to mL/hour (Runrapiq 300 mg/50 mL = 6 mg/mL):

Target dose (micrograms/kg body weight/min) × body weight (kg body weight) / 100 = infusion rate (mL/hour)

Conversion table (example):

Optional bolus administration in hemodynamically stable patients:
Conversion formula from 100 micrograms/kg body weight/min to ml/hour (Runrapiq 300 mg/50 ml = 6 mg/ml):
Loading dose infusion rate (ml/hour) over 1 minute = body weight (kg)
(Example: loading dose infusion rate of 70 ml/hour over 1 minute for a patient weighing 70 kg)

If adverse reactions occur, the landiolol dose should be reduced or infusion discontinued, and the patient should receive appropriate medical care as needed. In the event of hypotension or bradycardia, landiolol administration may be resumed at a lower dose after blood pressure or heart rate returns to acceptable levels. Particular caution is required during dose adjustment and maintenance infusion in patients with low systolic blood pressure.

In case of overdose, the following symptoms may occur: severe arterial 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.
In case of overdose, administration of landiolol should be immediately discontinued.

Switching to an alternative medication: After achieving adequate heart rate control and clinical stabilization, transition to alternative medications (such as oral antiarrhythmics) may be considered.
When replacing landiolol with alternative medications, the physician should carefully review the prescribing information and dosing recommendations for the alternative agent. When substituting landiolol with an alternative medicinal product, the landiolol dose may be reduced as follows:

• During the first hour after administering the first dose of the alternative medication, reduce the landiolol infusion rate by half (50%).

• After administering the second dose of the alternative medication, monitor the patient's response. If satisfactory control is maintained for at least one hour, landiolol infusion may be discontinued.

Special patient groups
Elderly patients (≥65 years)
No dose adjustment is necessary.

Patients with renal impairment
No dose adjustment is necessary.

Patients with hepatic impairment
Data on treatment in patients with hepatic impairment are limited. Caution is recommended in patients with any degree of hepatic impairment, starting with the lowest dose.

Cardiac dysfunction
To achieve heart rate control in patients with left ventricular dysfunction (LVEF <40%, CI <2.5 l/min/m², NYHA class 3–4), e.g., after cardiac surgery, during ischemia, or in septic conditions, lower initial doses of 1 microgram/kg body weight/min have been used, gradually increased under strict arterial pressure monitoring up to 10 micrograms/kg body weight/min. Further dose escalation may be considered under close hemodynamic monitoring if necessary and well tolerated by the patient, taking into account cardiovascular status.

Septic shock
In patients with septic shock, lower doses ranging from 1 microgram/kg body weight/min to a maximum of 40 micrograms/kg body weight/min have been used to control heart rate. Doses should be increased in increments of 1 microgram/kg body weight/min, with a minimum interval of 20 minutes between dose increases, under strict arterial pressure monitoring.

Children and adolescents
The safety and efficacy of landiolol in children under 18 years of age have not yet been established.

Method of administration
The medicinal product Runrapiq must be diluted before administration and used immediately after opening.
Do not mix the medicinal product Runrapiq with other medicinal products except those listed in section 6.6 of the SmPC.
Landiolol should be administered intravenously via central or peripheral access and should not be administered through the same intravenous line as other medications.

Unlike other beta-blockers, landiolol does not cause withdrawal tachycardia following abrupt discontinuation after 24 hours of continuous infusion. Nevertheless, patients should be closely monitored when discontinuing landiolol administration.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.
• Severe bradycardia (heart rate below 50 beats per minute)
• Sinus node disease
• Severe atrioventricular conduction disorders (without a pacemaker): second- or third-degree atrioventricular block
• Cardiogenic shock
• Severe arterial hypotension
• Decompensated heart failure not associated with cardiac arrhythmias
• Pulmonary hypertension
• Untreated pheochromocytoma
• Acute asthmatic attack
• Severe, uncorrectable metabolic acidosis