Betaloc

Package Leaflet: Information for the User

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

Betaloc (Seloken), 1 mg/ml, Solution for Injection

Metoprolol Tartrate
Betaloc and Seloken are different trade names for the same medicine.

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 to a specific 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-blockers (beta-adrenergic blocking agents). The action of the medicine involves blocking beta receptors in the heart, which results in a decrease in heart rate and cardiac muscle 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 painkillers from the opioid group.
• 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 of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other beta-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 be treated with a pacemaker),
• uncontrolled heart failure (shortness of breath, swelling of the ankles),
• bradycardia (heart rate below 45 beats per minute),
• very low blood pressure, which may cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis,
• untreated pheochromocytoma of the adrenal gland,
• suspected acute myocardial infarction, if the heart rate is slower than 45 beats per minute, the PQ interval is longer than 0.24 seconds, or the systolic blood pressure is less than 100 mmHg.
• if the patient is taking (short- or long-term) drugs with inotropic action, 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 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 (leg fatigue and weakness when walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic drugs),
• hyperthyroidism - Betaloc may mask symptoms,
• pheochromocytoma of the adrenal gland,
• psoriasis.

The doctor should be informed, even if the above warnings refer to 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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). If clonidine and Betaloc are used together, clonidine should not be stopped without consulting a doctor. If it is necessary to stop taking 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-blockers (e.g., in 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 - painkillers, anti-inflammatory drugs, 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 antiepileptic drugs),
• insulin or other antidiabetic drugs (their dosage 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 drinking alcohol 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-blockers, including metoprolol, may cause fetal damage and premature birth.
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 child.

Driving and using machines

The patient should check their individual reaction to Betaloc, as some patients may experience dizziness or fatigue that impairs their physical and mental 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. For accurate information on the sodium content in the solution used to dilute the product, refer to 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.

Dosing in case of tachycardia

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.
The total dose of 10 mg to 15 mg is usually sufficient. Doses of 20 mg or more are unlikely to produce additional clinical benefits.
Particular caution should be exercised if metoprolol is administered intravenously to patients with systolic blood pressure less than 100 mmHg. Administration of metoprolol may further lower blood pressure.

Dosing 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 cardiac care unit or similar 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 50 mg of metoprolol tartrate should be continued orally every 6 hours for 2 days.
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.

Use of 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 case of accidental administration of a dose 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 it is felt that the action of Betaloc is too strong or too weak, the doctor should be consulted.

Stopping treatment with Betaloc

Treatment with beta-blockers should not be stopped suddenly, nor should the dose be changed.
In case of any further doubts about the use of this medicine, the doctor or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine 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 less than 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 administering it,
• palpitations,
• changes in blood pressure related to changes in body position (rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhea,
• constipation,
• feeling of coldness in the hands and feet.

Uncommon (may affect less than 1 in 100 people)

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

Rare (may affect less than 1 in 1000 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 subsequent redness of the fingers with accompanying numbness and pain (Raynaud's syndrome),
• rhinitis,
• dryness of the mucous membranes 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 less than 1 in 10,000 people)

• gangrene (tissue death) 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 when 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 ankles (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 Drug Safety Monitoring of 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
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Betaloc

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. 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 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 made of colorless glass in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

RECORDATI Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali, 1, 20148 Milan, Italy

Manufacturer:

CIT S.r.l., Via Primo Villa, 17, 20875 Burago di Molgora (MB), Italy
Cenexi, 52 Rue Gaucher, 94120 Fontenay Sous Bois, France

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 Italy, the country of export: 023616055

Parallel import authorization number: 147/24

Date of approval of the leaflet: 11.04.2024

[Information about the trademark]