Betaloc

Package leaflet: Information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Betaloc, 1 mg/ml, solution for injection
Metoprolol tartrate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Betaloc is and what it is 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 Betaloc is and what it is used for

Metoprolol, the active substance in Betaloc, belongs to a group of medicines called β-adrenergic receptor blockers (β-blockers). The drug works by blocking β-receptors located in the heart, resulting in reduced heart rate and myocardial contractility, and consequently leads to a reduction in arterial blood pressure.
Indications for the use of Betaloc:

• Treatment of tachycardias, particularly supraventricular tachycardias.
• Early intravenous administration of Betaloc in patients with acute myocardial infarction reduces the infarct area and the risk of ventricular fibrillation. Reduction in pain intensity after administration may reduce the need for opioid analgesics.
• Administration 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-adrenergic receptor blocking drugs, e.g. atenolol, propranolol,
• if the patient has:
  • cardiogenic shock,
  • sick sinus syndrome (unless a cardiac pacemaker has been implanted),
  • second- or third-degree atrioventricular block (a condition which may be treated by implanting a pacemaker),
  • uncontrolled heart failure (shortness of breath, swelling around the ankles),
  • bradycardia (slowed heart rate below 45 beats per minute),
  • very low blood pressure which may cause fainting,
  • severe peripheral arterial circulatory disorders,
  • metabolic acidosis,
  • untreated phaeochromocytoma,
  • suspected acute myocardial infarction if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 s, or systolic blood pressure is less than 100 mmHg.
• if the patient is receiving (short- or long-term) drugs with beta-adrenergic stimulating inotropic action.

Warnings and precautions
Before starting treatment with Betaloc, discuss this with your doctor. Inform your doctor if the patient has:

• bronchial asthma, wheezing or other similar breathing disorders, or allergic reactions, e.g. to insect venom, food or other substances. If the patient has ever had an asthma attack or wheezing – do not use this medicine without consulting a doctor,
• chest pain caused by Prinzmetal's angina,
• circulatory disorders or heart failure,
• liver disease,
• first-degree heart block (conduction disturbances in the heart),
• intermittent claudication (tiring and weakening of one or both legs when walking),
• diabetes (your doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc may mask symptoms,
• phaeochromocytoma,
• psoriasis.

Inform your doctor even if the above warnings relate to conditions that occurred in the past.
Before planned anaesthesia, inform your dentist or anaesthesiologist that you are being treated with Betaloc.

Betaloc and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
In particular, inform your doctor or nurse if the patient is taking any of the following medicines:

• clonidine (used to treat high blood pressure or migraine). When being treated simultaneously with clonidine and Betaloc, do not stop taking clonidine without consulting your doctor. If it becomes necessary to discontinue clonidine or Betaloc, your doctor will inform you how to do so,
• terbinafine, propafenone and diphenhydramine,
• medicines that lower blood pressure (dihydropyridine derivatives, e.g. amlodipine, tricyclic antidepressants),
• ganglion-blocking agents, sympathomimetics (may be present, among others, in some cold remedies),
• beta-blockers (e.g. eye drops used, among others, in glaucoma treatment – 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 diseases),
• hydralazine (used to treat high blood pressure),
• cimetidine (a medicine used in peptic ulcer disease),
• rifampicin (used in bacterial infections),
• adrenaline (a medicine stimulating the heart),
• indomethacin, celecoxib – pain-relieving, anti-inflammatory medicines, used e.g. in joint inflammation,
• selective serotonin reuptake inhibitors (e.g. paroxetine, fluoxetine and sertraline, used to treat depression),
• phenothiazines (used to treat psychiatric disorders),
• barbiturates (sedative and anticonvulsant medicines),
• insulin or other antidiabetic medicines (dose adjustment may be necessary),
• lidocaine (a local anaesthetic),
• ergotamine derivatives (medicines used to treat migraine).

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

Taking Betaloc with food, drink and alcohol
Inform your doctor or nurse about alcohol consumption before taking Betaloc. Alcohol may affect the action of Betaloc.

Children and adolescents
Experience with the use of Betaloc in children is limited.

Elderly patients
There is no need to change the dose in elderly patients.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should inform her doctor before using this medicine.

Pregnancy
Betaloc should not be used during pregnancy unless the benefits of its use outweigh the risks to the fetus. Beta-blockers, including metoprolol, may cause fetal harm and premature delivery.
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 breastfed infant.

Driving and operating machinery
Check the patient's individual response after taking Betaloc, as some patients may experience dizziness or fatigue which may impair psychophysical performance.

Betaloc contains sodium
This medicine contains 17.7 mg of sodium in one 5 ml ampoule of injection solution (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 originating from the diluent should be taken into account when calculating the total sodium content in the prepared diluted product. For accurate information regarding the sodium content in the solution used to dilute the product, refer to the summary of product characteristics of the diluent used.

3. How to use Betaloc

Beteloc is intended for hospital use and should be administered by personnel experienced in treating patients with this product.
The medicine will be given intravenously.
The dose will be determined by the doctor and depends on the type of condition being treated.

Dosage for tachycardia
Initially, 5 mg of metoprolol should be 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 higher are unlikely to provide additional clinical benefit.
Extreme caution should be exercised when administering metoprolol intravenously to patients with systolic blood pressure below 100 mmHg. Administration of metoprolol may further reduce arterial blood pressure.

Dosage in myocardial infarction
Beteloc for intravenous injection should be administered as soon as possible after the onset of symptoms of myocardial infarction. Treatment should begin immediately on a cardiology ward or similar unit, once the patient's hemodynamic status has stabilized. Administer three doses of 5 mg as intravenous bolus injections, given 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, administer 50 mg of metoprolol tartrate orally, followed by continued administration of 50 mg of metoprolol tartrate orally every 6 hours for 48 hours.
The recommended maintenance dose of oral 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 initiated cautiously, starting with half the recommended oral dose.
After each dose (5 mg) of intravenous Betaloc, monitor arterial blood pressure and heart rate. Do not administer the next dose if the heart rate is less than 40 beats per minute, systolic blood pressure is below 90 mmHg, or the PQ interval is longer than 0.26 s. The next dose should also not be given if there is worsening dyspnea or if the patient's skin becomes cold and clammy.

Use of a higher or lower than recommended dose of Betaloc
Since Betaloc is administered by a physician, overdose of metoprolol is unlikely. In the event of accidental administration of a higher-than-recommended dose, supportive and symptomatic treatment should be initiated, including monitoring of cardiovascular, respiratory, and renal function, as well as blood glucose and electrolyte levels. Metoprolol is not removed by hemodialysis.
If you feel that the effect of Betaloc is too strong or too weak, consult your doctor.

Discontinuation of Betaloc treatment
Do not stop treatment with β-adrenolytics 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below is a list of adverse reactions that may occur during treatment with this medicine.

Very common (may occur in at least 1 out of 10 patients)

• fatigue

Common (may occur in less than 1 out of 10 patients)

• dizziness,
• headache,
• slowed heart rate; inform your doctor immediately, as they may need to reduce the dose or gradually discontinue the medicine,
• palpitations,
• changes in blood pressure related to changes in body position (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhoea,
• constipation,
• cold sensation in hands and feet.

Uncommon (may occur in less than 1 out of 100 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling, or numbness sensation (paraesthesiae),
• worsening of existing heart failure,
• disturbances in cardiac conduction observed on ECG (first-degree atrioventricular block),
• sudden drop in blood pressure during myocardial infarction (cardiogenic shock),
• bronchospasm,
• vomiting,
• skin rash,
• excessive sweating,
• muscle cramps,
• chest pain,
• oedema,
• weight gain.

Rare (may occur in less than 1 out of 1,000 patients)

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or eye irritation,
• conjunctivitis,
• disturbances in cardiac conduction, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, bluish discoloration, followed by redness of fingers with associated numbness and pain (Raynaud's syndrome),
• rhinitis,
• dryness of oral mucosa,
• hair loss,
• erectile dysfunction (impotence),
• liver function disorders (detected in blood tests),
• positive antinuclear antibody titre (antibodies used in diagnosing connective tissue diseases).

Very rare (may occur in less than 1 out of 10,000 patients)

• gangrene (tissue necrosis) in patients with severe peripheral circulatory disorders,
• reduced platelet count, which may lead to easy bruising,
• confusion,
• hallucinations,
• loss or disturbances of memory,
• taste disturbances,
• tinnitus,
• worsening of intermittent claudication (leg pain during 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, fatigue, or swelling around the ankles (in case of heart attack). These are uncommon adverse reactions, occurring in less than 1 out of 100 people.
• psoriasis (skin disease), circulatory disorders. These are rare adverse reactions, occurring in less than 1 out of 10,000 people.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide 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 below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the carton and label on the ampoule following: EXP. The expiry date refers to the last day of the stated 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 is metoprolol tartrate. One millilitre of solution contains 1 mg of metoprolol tartrate.
Other components 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 colourless glass in a cardboard box.

For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, 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

Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorisation number in Romania, country of export: 7137/2014/01
Parallel import authorisation number: 47/22

Information for healthcare professionals

Other sources of information
Detailed information on Betaloc, injection solution, 1 mg/ml, including information intended for healthcare professionals, is available in the Summary of Product Characteristics on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl.