Betaloc

Package Leaflet: Information for the User

Betaloc, 1 mg/ml, solution for injection
Metoprolol tartrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 is to block 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.
• Early administration of Betaloc by intravenous injection in patients with acute myocardial infarction reduces the area of infarction and the risk of ventricular fibrillation. Reduction of pain intensity after administration of the medicine may reduce the need for opioid analgesics.
• Use of Betaloc in acute myocardial infarction reduces mortality.

2. Important information before using Betaloc

When not to use 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 heart function is slower than 45 beats per minute, 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, discuss it with your doctor. Inform your doctor if you have:

• asthma, wheezing, or other similar respiratory disorders or allergic reactions, e.g. to insect bites, food, or other substances. If you have ever had an asthma attack or wheezing, do not use 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 dose of your diabetes medication),
• hyperthyroidism - Betaloc may mask symptoms,
• pheochromocytoma,
• psoriasis.

Inform your doctor, even if the above warnings relate to past situations.
Before planned anesthesia, inform your dentist or anesthesiologist about treatment with Betaloc.

Betaloc and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Particularly, 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, do not stop taking clonidine without consulting your doctor. If it is necessary to stop taking clonidine or Betaloc, your doctor will inform you how to do it,
• terbinafine, propafenone, and diphenhydramine,
• blood pressure-lowering medicines (dihydropyridine derivatives, e.g. amlodipine, tricyclic antidepressants),
• sympathetic ganglion blockers, sympathomimetics (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 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 diabetes medications (may need to change their dosage),
• lidocaine (a local anesthetic),
• ergotamine derivatives (medicines used to treat migraines).

Also, inform your doctor about any worrying reactions that have occurred after taking other medicines.

Using Betaloc with food, drink, and alcohol

Inform your doctor or nurse about drinking 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 are planning to have a baby, 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-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 baby.

Driving and using machines

Check your individual reaction to Betaloc, as it may cause dizziness or fatigue that can impair your ability to drive or operate machinery.

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 section "Other sources of information". 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 diluent.

3. How to use Betaloc

Betaloc is intended for use in a hospital setting 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 determined 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 benefit.
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 in intravenous injection should be used as soon as possible after the onset of symptoms of myocardial infarction. Treatment should be started in a cardiology department or similar, immediately after stabilization of the patient's hemodynamic status. Three doses of 5 mg should be administered in bolus, 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 of 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 you feel that the action of Betaloc is too strong or too weak, consult your doctor.

Stopping treatment with Betaloc

Do not stop treatment with beta-blockers or change the dose of the medicine on your own.
If you have any further questions about the use of this medicine, 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 Betaloc.

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; you should immediately inform your doctor, as he 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 hands and feet.

Uncommon (may affect less than 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 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 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 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 Betaloc:

• 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 those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Betaloc

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and label on the ampoule after: EXP. The expiry date refers to the last day of the month.
Explanation of abbreviations used on the carton and label:
"EXP" means expiry date
"Lot" means batch number.

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.
Ampoule made of colorless glass in a cardboard box.

Marketing authorization holder

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
To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
phone: +48 22 206 84 50

Date of last revision of the leaflet:

Other sources of information
Detailed information about this medicine, including information intended for healthcare professionals
only, can be found in the Summary of Product Characteristics available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
www.urpl.gov.pl.