Betaloc Zok 25

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Betaloc ZOK 25(Betaloc ZOK)
23.75 mg, prolonged-release tablets
Metoprolol succinate
Betaloc ZOK 25 and Betaloc ZOK are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Betaloc ZOK 25 and what is it used for
• 2. Important information before using Betaloc ZOK 25
• 3. How to use Betaloc ZOK 25
• 4. Possible side effects
• 5. How to store Betaloc ZOK 25
• 6. Contents of the packaging and other information

1. What is Betaloc ZOK 25 and what is it used for

Betaloc ZOK 25 contains the active substance metoprolol, which belongs to a group of drugs called beta-adrenergic blockers..
Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion.
This leads to a slowing of heart rate (reduced heart rate).
Betaloc ZOK 25 is used in the treatment of:

• 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,
• heart 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 medications, to increase survival, reduce hospitalization, improve left ventricular function, and improve quality of life.

Betaloc ZOK 25 is used in the prevention of:

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

Betaloc ZOK 25 is used to treat high blood pressure (hypertension) in children and adolescents aged 6 to 18 years.

2. Important information before using Betaloc ZOK 25

When not to use Betaloc ZOK 25:

• 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 below 45 beats per minute),
• very low blood pressure that may cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute myocardial infarction, if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 seconds, or systolic blood pressure is less than 100 mmHg,

Warnings and precautions

Before starting treatment with Betaloc ZOK 25, you should discuss it with your doctor. You should inform your doctor if you have:

• asthma, wheezing, or other respiratory disorders, or allergic reactions, such as to insect bites, food, or other substances. If you have ever had an asthma attack or wheezing, you should not use this drug without consulting your 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 (fatigue and weakness of one or both legs when walking),
• diabetes (your doctor may recommend changing the dose of your antidiabetic medication),
• hyperthyroidism - Betaloc ZOK 25 may mask its symptoms,
• pheochromocytoma,
• psoriasis.

You should consult your doctor, even if the above warnings refer to past situations.
Before planned anesthesia, you should inform your dentist or anesthesiologist that you are taking Betaloc ZOK 25.
You should not suddenly stop taking Betaloc ZOK 25. If it is necessary to stop treatment, the drug should be discontinued gradually, if possible, over a period of at least two weeks, in decreasing doses, to half a 25 mg tablet per day, for at least four days before completely stopping the drug.

Betaloc ZOK 25 and other drugs

You should tell your doctor about all the drugs you are currently taking, or have recently taken, and about the drugs you plan to take. This includes eye drops, injectable drugs, over-the-counter drugs, including herbal medicines and dietary supplements. Some drugs may affect the action of other drugs. You should consult your doctor if you are taking any of the following drugs:

• Drugs used to treat cardiovascular diseases (such as digitalis/digoxin, calcium antagonists, antiarrhythmic drugs, drugs blocking sympathetic ganglia, hydralazine).
• Other drugs, such as monoamine oxidase inhibitors (MAO), inhaled anesthetics, antibacterial drugs (rifampicin), drugs used to treat stomach ulcers (cimetidine), anti-inflammatory drugs (e.g., indomethacin, celecoxib), some antidepressant and antipsychotic drugs, antihistamine drugs, other beta-adrenergic receptor blockers (e.g., eye drops), and other substances (e.g., alcohol, some hormones).
• If you are taking clonidine and Betaloc ZOK 25 and it is necessary to stop clonidine treatment, Betaloc ZOK 25 should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 25 can be found in the "Warnings and precautions" section.
• If you are taking oral antidiabetic drugs, your doctor may change their dosage.

Betaloc ZOK 25 with food, drink, or alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor before using this drug.
Pregnancy
Betaloc ZOK 25 should not be used in pregnant women, unless the benefits of its use outweigh the risk to the fetus. In general, beta-adrenergic blockers, including metoprolol, may cause fetal harm and premature birth.
If a woman treated with Betaloc ZOK 25 becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK 25 should not be used during breastfeeding, unless the benefits of its use outweigh the risk to the breastfed child.

Driving and operating machines

You should check your individual reaction to Betaloc ZOK 25, as it may cause dizziness or fatigue that impairs psychophysical performance.

Betaloc ZOK 25 contains sodium

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

3. How to use Betaloc ZOK 25

This drug should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), and Betaloc ZOK 100 (95 mg) are available on the market.
Tablets of Betaloc ZOK 25 (or their halves) should not be chewed or crushed. Tablets (or their halves) should be swallowed with a liquid.
It is usually recommended to take Betaloc ZOK 25 once a day, with or without food. Your doctor will inform you how and when to take the tablets.
Hypertension
Adults
The recommended dose of the drug 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 drug.
Children and adolescents
In children and adolescents over 6 years of age, the dose depends on the child's body weight. The doctor will determine the appropriate dose.
Usually, the 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 25 should not be used in children under 6 years of age.
Angina pectoris
The recommended dose of the drug is 100-200 mg once a day. If necessary, the doctor may prescribe Betaloc ZOK 25 in combination with other drugs 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.
Heart rhythm disorders
The recommended dose of Betaloc ZOK 25 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 myocardial infarction or sudden death after the acute phase of myocardial infarction
myocardial infarction
The recommended dose is 200 mg once a day.
Migraine prophylaxis
The recommended dose is 100-200 mg once a day.
If you feel that the effect of Betaloc ZOK 25 is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Betaloc ZOK 25 than recommended

In case of taking a higher dose of Betaloc ZOK 25 than recommended, you should immediately consult your doctor or go to the emergency department of the nearest hospital.
In case of significant overdose of the drug, 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, cold skin, weak pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missing a dose of Betaloc ZOK 25

You should not take a double dose to make up for a missed dose.
In case of missing a dose of Betaloc ZOK 25, if it has been less than 12 hours since the planned time of taking the dose, you should take the missed dose immediately. If you remember about the missed dose after 12 or more hours, you should skip the missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all drugs, this drug may cause side effects, although not everyone will experience them.
The following side effects may occur when using this drug.

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

• fatigue.

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

• dizziness,
• headache,
• slow heart rate; you should immediately inform your doctor about this, as they may reduce the dose of the drug or gradually discontinue it,
• heart 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 occur in less than 1 in 100 patients)

• 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 occur in less than 1 in 1000 patients)

• 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, and then 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 occur in less than 1 in 10,000 patients)

• gangrene (tissue necrosis) 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 drug:

• shortness of breath, feeling of fatigue, or swelling of the ankles (in case of myocardial infarction). 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 you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 will help gather more information on the safety of the drug.

5. How to store Betaloc ZOK 25

The drug should be stored out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Do not take this drug if the packaging is damaged.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What does Betaloc ZOK 25 contain

• The active substance of the drug is metoprolol succinate.
• One tablet contains 23.75 mg of metoprolol succinate, which corresponds to 25 mg of metoprolol tartrate.
• The other ingredients of the drug are: ethyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide (E 171).

What does Betaloc ZOK 25 look like and what does the packaging contain

White or almost white, oval tablets with dimensions of 5.5 mm x 10.5 mm, with a notch on both sides, marked with "A/β" on one side. The tablet can be divided into equal doses.
PVC/Al blisters in a cardboard box.
28 pieces - 2 blisters of 14 pieces each.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, country of export:

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

Manufacturer:

Savio Industrial S.r.l.
Via Emilia, 21, 27100 Pavia, Italy
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje, Sweden
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali, 1, 20148 Milan, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Lithuania, country of export:LT/1/96/2252/002

Parallel import authorization number: 451/22 Date of leaflet approval: 28.12.2022

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