Betaloc Zok 50

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Betaloc ZOK 50 (Betaloc ZOK)

47.5 mg, prolonged-release tablets

Metoprolol succinate
Betaloc ZOK 50 and Betaloc ZOK are different trade names for the same drug.

The contents of the leaflet should be carefully read before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Betaloc ZOK 50 and what is it used for
• 2. Important information before taking Betaloc ZOK 50
• 3. How to take Betaloc ZOK 50
• 4. Possible side effects
• 5. How to store Betaloc ZOK 50
• 6. Contents of the packaging and other information

1. What is Betaloc ZOK 50 and what is it used for

Betaloc ZOK 50 contains the active substance metoprolol, which belongs to a group of medicines called beta-blockers.
Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion.
This leads to a slowing of the heart rate (reduction of heart rate).
Betaloc ZOK 50 is used in the treatmentof:

• high blood pressure (hypertension) to lower blood pressure and reduce the risk of complications (such as heart attack or stroke) and death (including sudden death) from cardiovascular causes,
• chest pain caused by insufficient blood supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow down the heart rate,
• palpitations (awareness of heart rate) due to non-organic (functional) heart disorders,
• chronic heart failure (with symptoms such as shortness of breath and swelling of the ankles), in combination with other heart failure medicines, to increase survival, reduce hospitalization, improve left ventricular function, and improve quality of life.

Betaloc ZOK 50 is used in the preventionof:

• another heart attack or sudden death after the acute phase of a heart attack,
• migraine attacks.

Betaloc ZOK 50 is used to treat high blood pressure (hypertension) in children and adolescents from 6 to 18 years old.

2. Important information before taking Betaloc ZOK 50

When not to take Betaloc ZOK 50

• 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, such as atenolol, propranolol,
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker is implanted),
• second- or third-degree atrioventricular block,
• uncontrolled heart failure (shortness of breath, swelling of the ankles),
• bradycardia (heart rate slower than 45 beats per minute),
• very low blood pressure that may cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute heart attack, if the heart rate is less than 45 beats per minute, the PQ interval is longer than 0.24 seconds, or the systolic blood pressure is less than 100 mmHg,
• if the patient is taking (short- or long-term) drugs with positive inotropic effects, stimulating beta-adrenergic receptors.

Warnings and precautions

Before starting treatment with Betaloc ZOK 50, the doctor should be consulted. The doctor should be informed if the patient has:

• asthma, wheezing, or other respiratory disorders or allergic reactions, such as to insect bites, food, or other substances. If the patient has ever had an asthma attack or wheezing, they should not take this medicine without consulting a 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 (leg fatigue or weakness when walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism - Betaloc ZOK 50 may mask its symptoms,
• pheochromocytoma,
• psoriasis.

The doctor should be consulted, even if the above warnings refer to past situations.
Before planned anesthesia, the dentist or anesthesiologist should be informed about taking Betaloc ZOK 50.
Treatment with Betaloc ZOK 50 should not be stopped suddenly. If it is necessary to stop treatment, the medicine should be gradually discontinued, if possible, over a period of at least two weeks in decreasing doses, to half a 25 mg tablet once a day, for at least four days before completely stopping the medicine.

Betaloc ZOK 50 and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes eye drops, injectable medicines, over-the-counter medicines, including herbal medicines and dietary supplements.
Some medicines may affect the action of other medicines. The doctor should be consulted if the patient is taking any of the following medicines:

• Medicines used to treat cardiovascular diseases (such as digitalis glycosides/digoxin, calcium antagonists, antiarrhythmic medicines, sympathetic ganglion blockers, hydralazine),
• Other medicines, such as monoamine oxidase inhibitors (MAOIs), inhaled anesthetics, antibiotics (rifampicin), medicines used to treat ulcers (cimetidine), anti-inflammatory medicines (e.g., indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic receptor blockers (e.g., eye drops), and other substances (e.g., alcohol, certain hormones),
• If the patient is taking clonidine and Betaloc ZOK 50 and it is necessary to stop clonidine treatment, Betaloc ZOK 50 should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 50 can be found in the "Warnings and precautions" section.
• If the patient is taking oral antidiabetic medicines, the doctor may change their dosage.

Betaloc ZOK 50 with food, drink, or alcohol

Consuming alcohol while taking metoprolol may enhance the effect of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
Pregnancy
Betaloc ZOK 50 should not be taken by pregnant women unless the benefits of its use outweigh the risks to the fetus. In general, beta-blockers, including metoprolol, may cause fetal harm and premature birth.
If a woman taking Betaloc ZOK 50 becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK 50 should not be taken during breastfeeding unless the benefits of its use outweigh the risks to the breastfed child.

Driving and using machines

The patient should check their individual reaction to Betaloc ZOK 50, as it may cause dizziness or fatigue that impairs physical and mental performance.

Betaloc ZOK 50 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Betaloc ZOK 50

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Tablets of Betaloc ZOK 50 (or their halves) should not be chewed or crushed. The tablets (or their halves) should be swallowed with a liquid.
Available are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).
It is usually recommended to take Betaloc ZOK 50 once a day, with or without food. The doctor will inform the patient how and when to take the tablets.
Hypertension
Adults
The recommended dose of the medicine for patients with mild to moderate hypertension is 50 mg once a day. If the response to the 50 mg dose is insufficient, the doctor may increase it to 100-200 mg once a day and (or) add another antihypertensive medicine.
Children and adolescents
In children and adolescents over 6 years old, the dose depends on the child's body weight. The doctor will determine the appropriate dose.
The usual initial dose is 0.5 mg/kg body weight, not more than 50 mg, given once a day in the form of a tablet with a strength close to the estimated dose.
The doctor may increase the dose to 2 mg/kg body weight, depending on the achieved blood pressure values.
Betaloc ZOK 50 should not be taken by children under 6 years old.
Angina pectoris
The recommended dose of the medicine is 100-200 mg once a day. If necessary, the doctor may prescribe Betaloc ZOK 50 in combination with other medicines used to treat angina pectoris.
Symptomatic, chronic heart failure
The dose will be determined by the doctor. The recommended initial dose is 1 tablet of 25 mg once a day for the first 2 weeks of treatment. Patients with more severe heart failure may be prescribed half a 25 mg tablet once a day for the first week of treatment. Then the doctor will double the dose every two weeks, up to a maximum dose of 200 mg once a day or the maximum tolerated dose by the patient.
Arrhythmias
The recommended dose of Betaloc ZOK 50 is 100-200 mg once a day.
Functional heart disorders with palpitations
The recommended dose is 100 mg once a day. If necessary, the doctor may increase the dose to 200 mg once a day.
Prevention of another heart attack or sudden death after the acute phase of a heart attack
Prevention of heart attack
The recommended dose is 200 mg once a day.
Migraine prophylaxis
The recommended dose is from 100 mg to 200 mg once a day.
If the patient feels that the effect of Betaloc ZOK 50 is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Betaloc ZOK 50 than recommended

In case of taking a higher dose of Betaloc ZOK 50 than recommended, the doctor or the emergency department of the nearest hospital should be contacted immediately.
In case of significant overdose, the following symptoms may occur: slow or irregular heart rate, shortness of breath, swelling of the ankles, feeling of strong heartbeat, dizziness, fainting, pain or pressure in the chest, cool skin, weak pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missing a dose of Betaloc ZOK 50

A double dose should not be taken to make up for a missed dose.
If a dose of Betaloc ZOK 50 is missed, and it has been less than 12 hours since the planned time of taking the dose, the missed dose should be taken immediately. If the patient remembers the missed dose after 12 or more hours, the missed dose should be skipped. The next dose should be taken at the usual time.

4. Possible side effects

Like all medicines, Betaloc ZOK 50 can cause side effects, although not everybody gets them.
The following side effects may occur when taking this medicine.

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; the doctor should be informed immediately, as they may reduce the dose of the medicine or gradually discontinue it,
• 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 cold 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 the ECG (first-degree atrioventricular block),
• sudden drop in blood pressure during a heart attack (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,
• vision disorders,
• dryness and (or) irritation of the eyes,
• conjunctivitis,
• conduction disorders in the heart, arrhythmias, worsening of existing atrioventricular block,
• pallor, 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 (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 when taking this medicine:

• shortness of breath, feeling of fatigue, or swelling of the ankles (in case of heart attack). 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Betaloc ZOK 50

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 30°C.
Store 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 month stated.
Do not take this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Betaloc ZOK 50 contains

• The active substance of the medicine is metoprolol succinate.
• One tablet contains 47.5 mg of metoprolol succinate, which corresponds to 50 mg of metoprolol tartrate.
• The other ingredients of the medicine are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide (E 171).

What Betaloc ZOK 50 looks like and contents of the pack

White or almost white, round tablets with a diameter of 9 mm, with a notch on one side, marked with "A/mO" on the other side. The notch line is designed to facilitate breaking the tablet only to make it easier to swallow, and not to divide the tablet into equal doses.
HDPE bottle containing 30 tablets, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Lithuania, country of export:

Recordati Ireland Ltd
Raheens East, Ringaskiddy
Co. Cork, P43 KD30
Ireland

Manufacturer:

AstraZeneca AB
Gärtunavägen
S-151 85 Södertälje
Sweden
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 Utebo (Saragossa)
Spain
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia
Italy
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milano
Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian authorization number: LT/1/96/2252/004

Parallel import authorization number: 46/18 Date of approval of the leaflet: 13.01.2023

[Information about the trademark]