Betaloc

Leaflet attached to the packaging: information for the user

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

Betaloc, 1 mg/ml (5 mg/5 ml), solution for injection

Metoprolol tartrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on 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 tell 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 taking Betaloc
• 3. How to take Betaloc
• 4. Possible side effects
• 5. How to store Betaloc
• 6. Contents of the packaging 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 contractility of the heart muscle, and consequently leads to a decrease in blood pressure.

Indications for use of Betaloc:

• Treatment of tachycardias, especially supraventricular ones.
• 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 analgesic medications from the opioid group.
• The use of Betaloc in acute myocardial infarction reduces mortality.

2. Important information before taking Betaloc

When not to take Betaloc

• 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 (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 cardiac 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.

Warnings and precautions

Before starting treatment with Betaloc, you should discuss it with your doctor. You should inform your doctor if you have:

• asthma, wheezing, or other similar respiratory disorders or allergic reactions, such as to insect bites, food, or other substances. If you have ever had an asthma attack or wheezing, you should not take this medicine without consulting your 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 of one or both legs when walking),
• diabetes (your doctor may recommend changing the doses of your antidiabetic medications),
• hyperthyroidism - Betaloc may mask the symptoms,
• pheochromocytoma,
• psoriasis.

You should inform your doctor, even if the above warnings concern situations that occurred in the past.

Before planned anesthesia, you should inform your dentist or anesthesiologist about treatment with Betaloc.

Betaloc and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

In particular, you should inform your doctor or nurse about taking any of the following medicines:

• clonidine (used to treat high blood pressure or migraine). If you are being treated with clonidine and Betaloc, you should not stop taking clonidine without consulting your doctor. If it is necessary to stop taking clonidine or Betaloc, your doctor will tell you how to do it,
• terbinafine, propafenone, and diphenhydramine,
• blood pressure-lowering medicines (dihydropyridine derivatives, such as amlodipine, tricyclic antidepressants),
• medicines that block sympathetic ganglia, 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 (it may be necessary to change their doses),
• lidocaine (a local anesthetic),
• ergotamine derivatives (medicines used to treat migraines).

You should also inform your doctor about any worrying reactions that occurred after taking other medicines.

Using Betaloc with food, drink, and alcohol

You should inform your doctor or nurse about consuming alcohol before taking 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 you are pregnant, think you may be pregnant, or plan to have a child, you should inform your doctor before taking 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 harm and premature birth.

If a woman being 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

You should check how you react to Betaloc, as it may cause dizziness or fatigue that affects your 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 - see the "Other sources of information" section.

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, you should consult the characteristics of the medicinal product of the diluent used.

3. How to take 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 your 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.

A 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 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 the heart rate 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 sweaty and cold.

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 case 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 you feel that the action of Betaloc is too strong or too weak, you should consult your doctor.

Stopping treatment with Betaloc

You should not stop treatment with beta-adrenolytics on your own or change the dose of the medicine.

If you have any further doubts about the use of this medicine, you should consult your 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; you should immediately inform your doctor, 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 (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhea,
• constipation,
• feeling of coldness in the hands and feet.

Uncommon (may affect up to 1 in 100 people)

• depression,
• insomnia,
• nightmares,
• concentration disorders,
• drowsiness,
• feeling of burning, tingling, or numbness (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,
• paleness, 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 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 edema (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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, 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 181C

PL-02 222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

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

By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Betaloc

Keep the medicine out of sight and reach of children.

Store in a temperature below 25°C, in the original packaging.

Do not use this medicine 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.

You should ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging 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 purified water.

What Betaloc looks like and what the packaging contains

5 ampoules of 5 ml each.

An ampoule made of colorless glass in a cardboard box.

To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali 1, 20148 Milan

Italy

Manufacturer:

CENEXI

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 Romania, the country of export: 7137/2014/01

Parallel import authorization number: 272/20

Date of approval of the leaflet: 20.06.2022

[Information about the trademark]