Betaloc

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Betaloc, 1 mg/ml, Solution for Injection

Metoprolol Tartrate

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Betaloc and what is it used for

Metoprolol, the active substance of Betaloc, belongs to a group of medicines called beta-adrenergic receptor blockers (beta-adrenolytics). The action of the medicine is based on blocking beta receptors in the heart, which results in a decrease in heart rate and myocardial contractility, and consequently leads to a decrease in blood pressure.

Indications for use of Betaloc:

• Treatment of tachycardias, especially supraventricular.
• Early administration of Betaloc by intravenous injection in patients with acute myocardial infarction reduces the area of infarction and the risk of ventricular fibrillation. The reduction in pain intensity after administration of the medicine may reduce the need for analgesics from the opioid group.
• The use of Betaloc in acute myocardial infarction reduces mortality.

2. Important information before using Betaloc

When not to use Betaloc

• if the patient is allergic to metoprolol tartrate or any other component of this medicine (listed in section 6).
• if the patient is allergic to other beta-adrenergic receptor blockers, such as atenolol, propranolol.
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker is implanted),
• second- or third-degree atrioventricular block (a condition that may require pacemaker implantation),
• uncontrolled heart failure (dyspnea, edema),
• bradycardia (heart rate below 45 beats per minute),
• very low blood pressure, which may cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute myocardial infarction, if heart function is slower than 45 beats per minute, the PQ interval is longer than 0.24 seconds, or systolic blood pressure is less than 100 mmHg.
• if the patient is taking (short- or long-term) drugs with inotropic effects, stimulating beta-adrenergic receptors.

Warnings and precautions

Before starting treatment with Betaloc, the doctor should be consulted. The doctor should be informed if the patient has:

• asthma, wheezing, or other similar respiratory disorders or allergic reactions, such as to insect bites, food, or other substances. If the patient has ever had an asthma attack or wheezing, they should not use this medicine without consulting a doctor,
• chest pain caused by Prinzmetal's angina,
• circulatory disorders or heart failure,
• liver disease,
• first-degree atrioventricular block (conduction disorders in the heart),
• intermittent claudication (fatigue and weakness in one or both legs while walking),
• diabetes (the doctor may recommend changing the doses of antidiabetic drugs),
• hyperthyroidism - Betaloc may mask symptoms,
• pheochromocytoma,
• psoriasis.

The doctor should be informed, even if the above warnings concern past situations.

Before planned anesthesia, the dentist or anesthesiologist should be informed about treatment with Betaloc.

Betaloc and other medicines

The doctor should be told about all medicines currently or recently taken by the patient, as well as any medicines planned for use.

In particular, the doctor or nurse should be informed about taking any of the following medicines:

• clonidine (used to treat high blood pressure or migraines). In the case of concurrent treatment with clonidine and Betaloc, clonidine should not be discontinued without consulting a doctor. If it is necessary to discontinue clonidine or Betaloc, the doctor will inform the patient how to do it,
• terbinafine, propafenone, and diphenhydramine,
• blood pressure-lowering medicines (dihydropyridine derivatives, such as amlodipine, tricyclic antidepressants),
• sympathetic ganglion blockers, sympathomimetics (which may be found in some cold medicines),
• beta-adrenolytics (e.g., in the form of eye drops, used to treat glaucoma - timolol),
• monoamine oxidase inhibitors,
• verapamil, diltiazem, nifedipine (used to treat high blood pressure and chest pain),
• quinidine, amiodarone, or digitalis glycosides (used to treat heart conditions),
• hydralazine (used to treat high blood pressure),
• cimetidine (a medicine used to treat stomach ulcers),
• rifampicin (used to treat bacterial infections),
• adrenaline (a medicine that stimulates the heart),
• indomethacin, celecoxib - pain, anti-inflammatory medicines used, for example, in the case of

arthritis,

• selective serotonin reuptake inhibitors (e.g., paroxetine, fluoxetine, and sertraline, used to treat depression),
• phenothiazine (used to treat mental disorders),
• barbiturates (sedatives and anticonvulsants),
• insulin or other antidiabetic medicines (their doses may need to be changed),
• lidocaine (a local anesthetic),
• ergotamine derivatives (medicines used to treat migraines).

The doctor should also be informed about any worrying reactions that occurred after taking other medicines.

Using Betaloc with food, drink, and alcohol

The doctor or nurse should be informed about alcohol consumption before administering Betaloc.

Alcohol may affect the action of Betaloc.

Children and adolescents

There is limited experience with the use of Betaloc in children.

Elderly patients

There is no need to change the dose in elderly patients.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should inform her doctor before using this medicine.

Pregnancy

Betaloc should not be used in pregnant women unless the benefits of its use outweigh the risks to the fetus.

Beta-adrenolytics, including metoprolol, may cause fetal damage and premature labor.

If a woman treated with Betaloc becomes pregnant, she should inform her doctor as soon as possible.

Breastfeeding

Betaloc should not be used during breastfeeding unless the benefits of its use outweigh the risks to the baby.

Driving and using machines

The patient should check their individual reaction to Betaloc, as some patients may experience dizziness or fatigue that impairs psychophysical performance.

Betaloc contains sodium

This medicine contains 17.7 mg of sodium in one 5 ml ampoule of solution for injection (1 ml contains 3.54 mg of sodium), i.e., less than 1 mmol of sodium (23 mg).

This medicine may be diluted with 0.9% sodium chloride solution or mannitol 150 mg/ml, glucose 100 mg/ml, glucose 50 mg/ml, and Ringer's solution.

The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the product.

To obtain accurate information about the sodium content in the solution used to dilute the product, the patient should consult the summary of product characteristics of the medicinal product used as the diluent.

3. How to use Betaloc

Betaloc is intended for use in a hospital and should be administered by personnel experienced in the treatment with this product.

The medicine will be administered intravenously.

The amount of medicine administered will be decided by the doctor.

The amount of medicine administered depends on the type of disease.

Dosage in case of tachycardias

Initially, 5 mg of metoprolol is administered intravenously at a rate of 1 mg to 2 mg per minute.

This dose may be repeated at 5-minute intervals until the desired clinical effect is achieved.

A total dose of 10 mg to 15 mg is usually sufficient.

Doses of 20 mg or more are unlikely to provide additional clinical benefit.

Particular caution should be exercised if metoprolol is administered intravenously to patients with systolic blood pressure below 100 mmHg.

Administration of metoprolol may further lower blood pressure.

Dosage in myocardial infarction

Betaloc by intravenous injection should be used as soon as possible after the onset of symptoms of myocardial infarction.

Treatment should be started in the cardiology department or a similar unit immediately after stabilizing the patient's hemodynamic status.

Three doses of 5 mg should be administered in bolus injections at 2-minute intervals, depending on the patient's hemodynamic status.

In patients who tolerated the total intravenous dose (15 mg), 15 minutes after the last intravenous dose, 50 mg of metoprolol tartrate should be administered orally, and the administration of 50 mg of metoprolol tartrate orally every 6 hours for 2 days should be continued.

The recommended maintenance dose of orally administered metoprolol tartrate is 100 mg twice daily (morning and evening) or 200 mg of metoprolol succinate once daily.

In patients who did not tolerate the full intravenous dose (15 mg) of Betaloc, oral treatment should be started cautiously with half the recommended oral dose.

After each dose (5 mg) of Betaloc administered intravenously, blood pressure and heart rate should be monitored.

The next dose of the product should not be administered if heart function is slower than 40/min, systolic blood pressure is less than 90 mmHg, and the PQ interval is longer than 0.26 seconds.

The next dose should also not be administered if there is an exacerbation of dyspnea or the patient's skin is cool and sweaty.

Using a higher or lower dose of Betaloc than recommended

Betaloc is administered by a doctor, so it is unlikely that an overdose of metoprolol will occur.

In the event of accidental administration of a dose of the medicine higher than recommended, supportive and symptomatic treatment should be used, including monitoring of cardiovascular, respiratory, renal, and blood glucose and electrolyte levels.

Betaloc is not removed by hemodialysis.

If the patient feels that the action of Betaloc is too strong or too weak, they should consult their doctor.

Stopping treatment with Betaloc

Treatment with beta-adrenolytics should not be stopped suddenly, nor should the dose be changed.

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Betaloc can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with this medicine:

Very common (may affect at least 1 in 10 people)

• fatigue.

Common (may affect up to 1 in 10 people)

• dizziness,
• headache,
• slow heart rate; the doctor should be informed immediately, as they may reduce the dose of the medicine or gradually stop its administration,
• palpitations,
• changes in blood pressure related to changes in body position (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhea,
• constipation,
• feeling of coldness in hands and feet.

Uncommon (may affect up to 1 in 100 people)

• depression,
• insomnia,
• nightmares,
• concentration disorders,
• drowsiness,
• tingling, numbness, or burning sensation (paresthesia),
• worsening of existing heart failure,
• conduction disorders in the heart, detected in the ECG (first-degree atrioventricular block),
• sudden decrease in blood pressure during infarction (cardiogenic shock),
• bronchospasm,
• vomiting,
• skin rash,
• increased sweating,
• muscle cramps,
• joint pain,
• edema,
• weight gain.

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

• nervousness,
• anxiety disorders,
• vision disorders,
• dryness and (or) irritation of the eyes,
• conjunctivitis,
• conduction disorders in the heart, arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, and then redness of the fingers with accompanying numbness and pain (Raynaud's syndrome),
• rhinitis,
• dryness of the mucous membrane of the mouth,
• hair loss,
• erectile dysfunction (impotence),
• liver function disorders (detected in blood tests),
• positive antinuclear antibody titer (antibodies used in the diagnosis of connective tissue diseases).

Very rare (may affect up to 1 in 10,000 people)

• gangrene (tissue necrosis) in patients with severe peripheral circulation disorders,
• decreased platelet count, which may cause easy bruising,
• confusion,
• hallucinations,
• memory loss or disorders,
• taste disorders,
• tinnitus,
• worsening of intermittent claudication (leg pain while walking),
• hepatitis,
• photosensitivity,
• exacerbation of psoriasis,
• joint pain.

Conditions that may worsen

The following conditions may worsen during treatment with this medicine:

• shortness of breath, feeling of fatigue, or swelling of the legs (in the case of myocardial infarction).
• These are uncommon side effects, occurring in less than 1 in 100 people.
• psoriasis (skin disease), circulatory disorders.
• These are rare side effects, occurring in less than 1 in 10,000 people.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.

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 181C

PL-02 222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Betaloc

The medicine should be stored out of sight and reach of children.

The ampoules should be stored in the outer packaging to protect them from light.

This medicine should not be used after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their 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 Betaloc contains

The active substance of Betaloc is metoprolol tartrate.

One milliliter of the solution contains 1 mg of metoprolol tartrate.

The other ingredients are sodium chloride and water for injections.

What Betaloc looks like and contents of the pack

5 ampoules of 5 ml each.

Ampoules (OPC) made of colorless glass in a cardboard box.

For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Herbacos Recordati s.r.o.

Štrossova 239, 530 03 Pardubice, Czech Republic

Manufacturer:

Cenexi SAS

52 rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France

CIT S.r.l.

Via Primo Villa, 17, 20875 Burago di Molgora (MB), Italy

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Marketing authorization number in the Czech Republic, the country of export: 58/171/82-C

Parallel import authorization number: 210/25

Date of approval of the leaflet: 20.06.2025

[Information about the trademark]