Package Insert: Information for the Patient

Beloken 1 mg/ml Injectable Solution

metoprolol tartrate

Read this entire package insert carefully beforeyou receive this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

Contents of the package and additional information

The active ingredient is metoprolol tartrate, which belongs to a group of medicines called beta-blockers. These medicines reduce the effect of hormones produced by stress on some parts of the body. In this way, metoprolol is able to act on blood vessels and the heart by reducing blood pressure and heart rate.

This medicine is used in adults for the treatment of:

• Abnormal heart rhythms, especially rapid heartbeats (supraventricular tachycardia).
• Treatment of hemodynamically stable patients with defined or suspected acute myocardial infarction. (Early intervention in the acute phase, prior to oral therapy).

Do not use Beloken 1 mg/ml

• if you are allergic to metoprolol or any of the other components of this medication (listed in section 6).
• if you have uncompensated heart failure, conduction disorder, or acute myocardial infarction.
• if you have ever experienced very slow or irregular heartbeats or circulatory insufficiency.

Beloken 1 mg/ml is not recommended for use in children.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Beloken:

• if you experience signs/symptoms of low blood sugar levels (hypoglycemia).
• if you have health problems such as asthma or breathing difficulties, circulatory disorders, heart problems, kidney problems, or thyroid problems.
• if during treatment with this medication your heart rate slows down further.
• if you have ever been informed that you have pheochromocytoma (a tumor in the adrenal glands).
• if you have very low blood pressure or severely impaired circulation.
• if you have uncontrolled heart failure.
• if you are allergic to insect bites, food, or other substances.

Inform your doctor about any health problems you have had in the past.

If you are an athlete, note that this medication contains a component that may result in a positive analytical control for doping.

If you have not informed your doctor about any of the above situations or have any doubts, consult with your doctor or pharmacist before starting treatment with this medication.

Use of Beloken 1 mg/ml with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication. Some medications may affect the action of other medications.

Especially inform your doctor if you are using any of the following medications, as you may need to adjust the dose of one or more medications:

• Medications used in cardiac and vascular treatments (such as digitalis/digoxin, calcium antagonists (verapamil or diltiazem), antiarrhythmic agents (quinidine or amiodarone), ganglionic blockers, hydralazine, clonidine).
• Other medications such as monoamine oxidase inhibitors (MAOIs), inhalation anesthetics, antibiotics (rifampicin), anti-ulcer medications (cimetidine), non-steroidal anti-inflammatory drugs (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-blockers (e.g. eye drops, asthma medications), and other substances (e.g. alcohol, some hormones, such as adrenaline), oral antidiabetic medications.

Consider the following:

• If you take clonidine and Beloken 1 mg/ml together and need to stop taking clonidine, you should stop taking metoprolol several days before stopping clonidine.
• If you are taking oral antidiabetic medications, your doctor may need to adjust the dose.

• The blood levels of this medication may be increased if administered with antiarrhythmic agents, antihistamines, antidepressants, antipsychotics, non-steroidal anti-inflammatory drugs, alcohol, or hydralazine.
• The blood levels of this medication may be decreased by rifampicin.
• The administration of this medication with antiarrhythmic agents (quinidine or amiodarone) increases the effect of these medications.
• The effects of this medication may be increased when administered with calcium antagonists (verapamil or diltiazem). Avoid co-administration of these medications.
• The effects of this medication may be decreased when administered with adrenaline or indomethacin.

Beloken 1 mg/ml with alcohol

Consuming alcohol may increase the levels of metoprolol in the blood, increasing the effect of the medication. Avoid taking alcohol with this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before being administered this medication.

Beta-blockers, including metoprolol, may harm the fetus and cause premature birth.

Inform your doctor if you are breastfeeding, as Beloken 1 mg/ml may cause adverse effects in the infant, such as slowed heart rate.

Driving and operating machinery

Some patients may feel tired or dizzy when taking Beloken. If this happens, do not drive or operate tools or machinery.

Beloken 1 mg/ml contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 5 ml of injectable solution (one ampoule); it is essentially "sodium-free".

Metoprolol intravenous injection is used in acute situations where rapid action is required and should only be administered byexperienced personnelwho can provide more information.

Your doctor will inform you of the duration of your treatment with this medication. Do not discontinue treatment unless your doctor instructs you to do so.

Treatment of hemodynamically stable patients with defined or suspected acute myocardial infarction. (Early intervention in the acute phase, prior to oral therapy):In the acute phase and as soon as possible after the patient's arrival at the hospital, 5 mg of metoprolol will be administered intravenously as a bolus. With a 2-minute interval, a second and third injection of 5 mg will be repeated, depending on the patient's hemodynamic status. (See "Before using Beloken 1 mg/ml").

Patients who have tolerated the total intravenous dose of 15 mg will be administered oral metoprolol succinate or tartrate 50 mg tablets 4 times a day for 48 hours, 15 minutes after the last injection.

Patients who do not tolerate the total intravenous dose of 15 mg will start oral treatment with caution, beginning with a lower dose.

Arrhythmias, particularly supraventricular tachycardia:Initially, 5 mg will be administered intravenously at a rate of 1-2 mg/minute. This dose may be repeated with a 5-minute interval until a satisfactory effect is achieved. A total dose of 10-15 mg generally achieves this effect.

Doses of 20 mg or more are unnecessary, as they do not provide additional therapeutic benefit.

Use in children and adolescents

Not recommended due to limited experience with Beloken in children and adolescents.

Use in elderly patients

The dose of this medication does not need to be adjusted in elderly patients.

If you estimate that the action of this medication is too strong or too weak, inform your doctor, healthcare personnel, or pharmacist.

If you are given moreBeloken 1 mg/ml than you should

If you consider that you have been given too much Beloken 1mg/ml, consult your doctor or pharmacist immediately.

In case of using a dose of this medication higher than recommended, if it is high enough, you may experience an overdose with the following symptoms: slow or irregular heart rate, difficulty breathing, swelling of ankles, sensation of palpitations, dizziness, chest pain, cold skin, weak pulse, confusion, anxiety, cardiac arrest, loss of consciousness or even coma, nausea, vomiting, blue discoloration of the skin, or hypotension (low blood pressure).

The first manifestations of an overdose may be observed between 20 minutes and 2 hours after administration of the drug. If you experience any of these symptoms, contact your doctor, pharmacist, or nearest hospital immediately.

In case of taking alcohol, antihypertensive medications, quinidine, or sedatives (barbiturates) along with metoprolol, the symptoms may worsen.

Treatment:

In case of severe hypotension and shock, plasma or plasma substitutes will be administered, and you will be kept under observation in the intensive care unit.

If the heart rate is excessively slow or irregular, atropine may be administered intravenously and/or a pacemaker may be used. If necessary, glucagon and/or dobutamine may be administered, and the administration of calcium ions may be considered. Bronchospasm may be reversed with a bronchodilator. For more information, see Technical Data Sheet.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Beloken 1 mg/mlis well tolerated and any unwanted effects that may occur are generally mild and disappear when treatment is stopped.

The following side effects have been reported in patients treated with metoprolol, although the relationship with metoprolol treatment has not been established in all cases. If you experience any of the adverse reactions described below persistently, inform your doctor.

Very common(mayaffect more than 1 in 10 people):

Common(mayaffect up to 1 in 10 people):

• dizziness, headache,
• slowing of heart rate, dizziness when changing position (rarely with loss of consciousness), cold hands and feet, palpitations,
• nausea, abdominal pain, diarrhea, constipation,
• sensation of shortness of breath when exerting oneself.

Uncommon (may affect up to 1 in 100 people):

• sensation of heat/hives/numbness, muscle cramps,
• symptoms of heart disease such as shortness of breath, weakness, and swelling of the ankles may worsen temporarily,
• during a heart attack, blood pressure may decrease excessively (cardiogenic shock), minor electrocardiogram changes without affecting heart function, swelling, chest pain,
• depression, altered concentration, drowsiness, insomnia, nightmares,
• skin rash, increased sweating,
• sensation of respiratory tract oppression,
• vomiting,
• weight gain.

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

• electrocardiogram conduction abnormalities, irregular heartbeats,
• nervousness, anxiety,
• liver problems (abnormal liver function tests),
• hair loss,
• nasal discharge due to allergic reaction,
• vision disorders, dryness and/or irritation of the eyes,
• dry mouth, tearing or eye irritation due to allergic reaction,
• impotence/sexual dysfunction.

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

• worsening of circulatory problems in the extremities in patients with severe circulatory disorders,
• joint pain,
• loss or deterioration of memory, confusion, hallucinations,
• skin reaction due to increased sensitivity to the sun, worsening of psoriasis,
• tinnitus,
• alterations in taste,
• blood disorders (decrease in platelet count in the blood)
• hepatitis.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the ampoules in the original packaging until they are used.

Composition of Beloken 1 mg/ml

• The active ingredient is metoprolol tartrate 5 mg.

• The other components (excipients) are: sodium chloride, injection water, c.s.p. 5 ml.

Aspect of the product and content of the container

Beloken 1 mg/ml is presented in a container of 5 glass ampoules of 5 mg (1 mg/ml).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milano

Italy

Responsible for manufacturing:

Cenexi

52 Rue Marcel et Jacques Gaucher

94120 Fontenay Sous Bois

France

or

CIT S.r.l.

Via Primo Villa, 17

20875 Burago di Molgora (MB)

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Casen Recordati, S.L.

Autovía de Logroño, km 13,300

50180 Utebo - Zaragoza

Spain

Last review date of this leaflet: January 2021

This information is intended solely for doctors or healthcare professionals:

MODE OF ADMINISTRATION

Figure 1 Figure 2

1) The ampoule has a mark below the blue dot (Figure 1).

2) Place the thumb on the blue dot and break the ampoule at the neck (Figure 2).

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/