Betaloc

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaloc
1 mg/ml (5 mg/5 ml), injection solution
Metoprololi tartras
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Leaflet contents

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 beta-adrenergic receptor blockers (beta-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 blood pressure.

Indications for Betaloc:

• Treatment of tachyarrhythmias, particularly supraventricular tachycardia.
• 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.
• Use 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 blockers, 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 implantation of a pacemaker),
  • uncontrolled heart failure (shortness of breath, swelling around the ankles),
  • bradycardia (slowing of the 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 function is slower 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 inotropic action stimulating beta-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc, discuss this with your doctor. You should 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 experienced an asthma attack or wheezing, this medicine should not be used 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 while walking),
• diabetes (your doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc may mask the symptoms,
• phaeochromocytoma,
• psoriasis.

You should inform your doctor even if the above warnings refer 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 take.
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). If clonidine and Betaloc are used together, do not stop taking clonidine without consulting your doctor. If it becomes necessary to discontinue clonidine or Betaloc, your doctor will advise 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 in some cold remedies),
• beta-blockers (e.g. eye drops used 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 that stimulates 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 harm the fetus and cause 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
The patient should assess their individual response after taking Betaloc, as dizziness or fatigue may occur in some patients, impairing psycho-physical performance.
Betaloc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in one 5 ml ampoule of injection solution, meaning the medicine is considered "sodium-free".
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 diluent 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 treatment with this medicine.
The medicine will be given intravenously.
The dose to be administered will be determined by the physician and depends on the type of condition being treated.

Dosage for tachyarrhythmias
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 higher are unlikely to provide additional clinical benefit.
Particular 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 been stabilized. Three intravenous bolus injections of 5 mg each should be given at 2-minute intervals, depending on the patient's hemodynamic status.
In patients who have tolerated the total intravenous dose (15 mg), 50 mg of metoprolol tartrate should be administered orally 15 minutes after the last intravenous dose, followed by continued oral administration of 50 mg metoprolol tartrate 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 Beteloc, oral treatment should be initiated cautiously, starting with half the recommended oral dose.

After each intravenous dose (5 mg) of Beteloc, arterial blood pressure and heart rate should be monitored. The next dose should not be administered 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 Beteloc
Since Beteloc is administered by a physician, overdose of metoprolol is unlikely. However, in the event of accidental administration of a higher than recommended dose, supportive and symptomatic treatment should be provided, 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 Beteloc is too strong or too weak, consult your doctor.

Stopping treatment with Beteloc
Do not discontinue treatment with beta-blockers on your own or change the dose of the medicine.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects listed below may occur during treatment with this medicine.

Very common (may affect at least 1 in 10 patients)

• fatigue.

Common (may affect less than 1 in 10 patients)

• dizziness,
• headache,
• slowing of the heart rate; inform your doctor immediately, as the dose may need to be reduced or the treatment may need to be gradually discontinued,
• palpitations,
• changes in blood pressure related to change in body position (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhoea,
• constipation,
• sensation of coldness in hands and feet.

Uncommon (may affect less than 1 in 100 patients)

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

Rare (may affect less than 1 in 1,000 patients)

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or eye irritation,
• conjunctivitis,
• disturbances in heart conduction, arrhythmias, worsening of existing atrioventricular block,
• pallor, bluish discoloration, followed by redness of fingers, accompanied by numbness and pain (Raynaud's phenomenon),
• nasal mucosal inflammation,
• dryness of the oral mucosa,
• hair loss,
• erectile dysfunction (impotence),
• liver function disturbances (detected in blood tests),
• positive antinuclear antibody titre (antibodies used in diagnosis of connective tissue diseases).

Very rare (may affect less than 1 in 10,000 patients)

• tissue necrosis (gangrene) 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, feeling of fatigue or swelling around the ankles (in case of heart attack). These are uncommon adverse effects, occurring in less than 1 in 100 people.
• psoriasis (a skin condition), circulatory disorders. These are rare adverse effects, occurring in less than 1 in 10,000 people.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store Betaloc

Keep this medicine out of 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 packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Betaloc contains
The active substance is metoprolol tartrate.
1 ml of solution contains 1 mg of metoprolol tartrate.
5 ml of solution contains 5 mg of metoprolol tartrate.
The 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 more detailed information, please contact the responsible entity or the 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
CIT S.r.l.
Via Primo Villa, 17
20875 Burago di Molgora (MB), Italy

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation number in Romania, country of export: 7137/2014/01
Parallel Import Authorisation number: 64/21