Metocard

Package Leaflet: Information for the Patient

Metocard, 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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Metocard and what is it used for

Metoprolol, the active substance of Metocard, belongs to a group of medicines called beta-blockers (β-adrenergic blockers). The action of the medicine is to block β-receptors in the heart, which results in a decrease in heart rate and cardiac muscle contraction, leading to a decrease in blood pressure. Metocardis used:

• to treat arrhythmias, especially supraventricular ones,
• in patients with acute myocardial infarction.

2. Important information before using Metocard

When not to use Metocard:

• if you are allergic to metoprolol tartrate, another β-blocker, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other β-adrenergic blockers, such as atenolol, propranolol.
• if you have:
• cardiogenic shock, characterized by: cold, wet, pale skin, low blood pressure, rapid and weak pulse, rapid and shallow breathing, decreased urine output,
• 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 slower than 45 beats per minute),
• very low blood pressure, which may cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis (imbalance of acid-base balance in the body),
• untreated pheochromocytoma (a benign tumor of the adrenal gland that causes high blood pressure),
• 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 you are taking (short- or long-term) drugs with inotropic action, stimulating β-adrenergic receptors.

Warnings and precautions

Before starting to use Metocard, discuss it with your doctor or nurse. Be particularly careful when using Metocard:

• 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 a doctor,
• if you have chest pain caused by Prinzmetal's angina,
• if you have circulation disorders or heart failure,
• if you have liver disease,
• if you have first-degree atrioventricular block (conduction disorders in the heart),
• if you have intermittent claudication (leg pain when walking),
• if you have diabetes (your doctor may recommend changing the doses of your diabetes medicines),
• if you have hyperthyroidism - Metocard may mask symptoms of hyperthyroidism, such as rapid heart rate, excessive sweating, tremors, increased appetite, and weight loss,
• if you have pheochromocytoma,
• if you have psoriasis.

Consult a doctor, even if the above warnings refer to situations that occurred in the past.

Children

Metocard should not be used in children.

Metocard and other medicines

Tell your doctor or nurse about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. In particular, inform your doctor or nurse if you are taking any of the following medicines:

• clonidine (used to treat high blood pressure or migraines). If you are being treated with clonidine and Metocard, do not stop taking clonidine without consulting a doctor. If it is necessary to stop taking clonidine or Metocard, your doctor will tell you how to do it.
• terbinafine (used to treat fungal infections),
• diphenhydramine (used to treat allergies),
• blood pressure-lowering medicines (dihydropyridine derivatives, e.g., amlodipine, tricyclic antidepressants),
• nerve-blocking agents, sympathomimetics (which may be found in some cold medicines),
• β-blockers (e.g., in the form of eye drops, used to treat glaucoma, e.g., timolol),
• monoamine oxidase inhibitors (used to treat depression),
• verapamil, diltiazem, nifedipine (used to treat high blood pressure and chest pain),
• quinidine, amiodarone, propafenone, or digitalis glycosides (used to treat heart conditions),
• hydralazine (used to treat high blood pressure),
• cimetidine (used to treat stomach ulcers),
• rifampicin (used to treat bacterial infections),
• adrenaline (a medicine that stimulates heart function),
• indomethacin, celecoxib (pain-relieving, anti-inflammatory medicines used, e.g., for 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 medicines (may need to change their doses),
• lidocaine (a local anesthetic),
• ergotamine derivatives (medicines used to treat migraines).

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

Anesthesia and surgery

Tell your doctor or dentist that you are taking Metocard before anesthesia or surgery, due to the possibility of excessive slowing of heart function.

Metocard with food, drink, or alcohol

Tell your doctor or nurse if you have consumed alcohol before taking Metocard. Alcohol may affect the action of Metocard.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Pregnancy Metocard should not be used in pregnant women unless the benefits of its use outweigh the risks to the fetus. If a woman being treated with Metocard becomes pregnant, she should inform her doctor as soon as possible. Breastfeeding Metocard should not be used during breastfeeding unless the benefits of its use outweigh the risks to the baby.

Driving and using machines

Taking Metocard may cause side effects such as dizziness or fatigue, which may affect your ability to drive or operate machinery.

Metocard contains sodium

The medicine contains 3.6 mg of sodium per 1 ml of solution. 5 ml of solution (one ampoule) contains 18 mg of sodium. This corresponds to 0.9% of the maximum recommended daily intake of sodium in the diet for adults. The medicine may be diluted - see the section "Information intended exclusively for healthcare professionals". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, consult the patient leaflet of the diluent used. This should be considered in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to use Metocard

This medicine should always be used exactly as your doctor or nurse has told you. If you are not sure, ask your doctor or pharmacist.

Adults

• Metocard is administered by a doctor or nurse.
• The medicine is administered by injection into a vein (intravenous administration).
• The amount of medicine given will be decided by your doctor. The amount of medicine given depends on the type of disease.

Children

Metocard should not be used in children. Detailed information on dosing can be found in the section "Information intended exclusively for healthcare professionals".

Using more or less Metocard than prescribed

If you think you have been given too much Metocard, tell your doctor or nurse immediately.

Stopping Metocard treatment

Only your doctor or nurse can decide to stop Metocard treatment. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Tell your doctor if you experience any of the following or any other side effects:

Very common (affects more than 1 in 10 people)

• fatigue

Common (affects less than 1 in 10 people)

• dizziness
• headache
• slow heart rate; you should immediately inform your doctor, as they may reduce the dose or gradually stop the medicine
• 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 hands and feet

Uncommon (affects 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 an ECG (first-degree atrioventricular block)
• sudden decrease in blood pressure during a heart attack (cardiogenic shock)
• bronchospasm
• vomiting
• skin rash
• increased sweating
• muscle cramps
• joint pain
• edema
• weight gain

Rare (affects less than 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, followed by 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 (affects 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 when using this medicine:

• shortness of breath, feeling of fatigue, or swelling of the ankles (in the case of a heart attack). These are uncommon side effects, occurring in less than 1 in 100 patients.
• psoriasis (skin disease), blood circulation disorders. These are very rare side effects, occurring in less than 1 in 10,000 patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 02-222 Warsaw tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metocard

Keep the medicine out of the sight and reach of children. There are no special precautions for storing the medicine. The diluted solution can be stored for up to 12 hours at a temperature up to 25°C. Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the month. The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metocard contains

• The active substance of Metocard is metoprolol tartrate. Each 1 ml of solution contains 1 mg of metoprolol tartrate. Each ampoule contains 5 mg of metoprolol tartrate.
• The other ingredients are: sodium chloride, water for injections.

What Metocard looks like and contents of the pack

Metocard is a colorless, clear solution. The pack contains 5 ampoules of colorless glass, each containing 5 ml, in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A. ul. Pelplińska 19 83-200 Starogard Gdański tel. +48 22 364 61 01

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals

• Metocard is intended for use in a hospital setting and should be administered by personnel experienced in the use of this medicine.
• The medicine is administered intravenously.
• The amount of medicine given will be decided by your doctor. The amount of medicine given depends on the type of disease.
• Metocard is a ready-to-use solution that can also be mixed with solutions of: 0.9% sodium chloride (9 mg/ml), 15% mannitol (150 mg/ml), 10% glucose (100 mg/ml), 5% glucose (50 mg/ml), Ringer's solution. Up to 40 mg of metoprolol can be diluted in 1000 ml of solution.

Dosing

Dosing for arrhythmias

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.

Dosing for myocardial infarction

Metocard should be administered intravenously as soon as possible after the onset of symptoms of myocardial infarction. Treatment should be started in a cardiology department or a similar unit, immediately after stabilizing the patient's hemodynamic status, with an intravenous dose of 5 mg. Then, 5 mg should be administered in bolus injections at 2-minute intervals, up to a total dose of 15 mg, 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 administered orally every 6 hours for 2 days. In patients who did not tolerate the full intravenous dose (15 mg) of Metocard, oral treatment should be started cautiously with half the recommended oral dose. The recommended maintenance dose of metoprolol tartrate is 100 mg twice daily (morning and evening) or 200 mg of metoprolol succinate once daily. After each dose (5 mg) of Metocard administered intravenously, blood pressure and heart rate should be monitored. The next dose of the medicine should not be administered if the heart rate is slower than 40 beats per minute, 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 worsening of shortness of breath or the patient's skin is sweaty and cold.