Betaloc Zok 50

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! 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.

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. Do not pass it on 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 tell their doctor or pharmacist. 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 using Betaloc ZOK 50
• 3. How to use 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 drugs called
β-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 (reduction of heart rate).
Betaloc ZOK 50 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 function) 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 50 is used in the prevention of:

• 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 aged 6 to 18 years.

2. Important information before using Betaloc ZOK 50

When not to use Betaloc ZOK 50:

• if the patient is allergic to metoprolol tartrate or any of the other ingredients of this drug (listed in section 6);
• if the patient is allergic to other β-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 can cause fainting,
• severe peripheral circulation disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute heart attack, if the heart rate is slower 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 being administered (short- or long-term) drugs with positive inotropic effects, stimulating β-adrenergic receptors.

Warnings and precautions

Before starting treatment with Betaloc ZOK 50, you should discuss it with your doctor. You should
inform your doctor if you have:

• asthma, wheezing, or other similar 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 in one or both legs when walking),
• diabetes (your doctor may recommend changing the dose of your diabetes medication),
• hyperthyroidism - Betaloc ZOK 50 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 about your treatment with Betaloc ZOK 50.
You should not suddenly stop taking Betaloc ZOK 50. 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, down to half a 25 mg tablet per day, for at least four days before completely stopping the drug.

Betaloc ZOK 50 and other drugs

You should tell your doctor about all the drugs you are currently taking or have recently taken, as well as any 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 glycosides/digoxin, calcium antagonists, antiarrhythmic drugs, sympathetic ganglion blockers, hydralazine).
• Other drugs, such as monoamine oxidase inhibitors (MAOIs), inhaled anesthetics, antibiotics (rifampicin), drugs used to treat stomach ulcers (cimetidine), anti-inflammatory drugs (e.g., indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other β-adrenergic receptor blockers (e.g., eye drops), and other substances (e.g., alcohol, certain hormones).
• If you are 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 you are taking oral diabetes medications, your doctor may change their dosage.

Betaloc ZOK 50 with food, drink, or alcohol

Consuming alcohol while taking metoprolol may enhance its effect.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this drug.
Pregnancy
Betaloc ZOK 50 should not be used in pregnant women, unless the benefits of its use outweigh the risks to the fetus. In general, β-adrenergic blockers, including metoprolol, may cause fetal harm and premature birth.
If a woman treated with Betaloc ZOK 50 becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK 50 should not be used during breastfeeding, unless the benefits of its use outweigh the risks to the breastfed child.

Driving and using machines

You should check your individual reaction to Betaloc ZOK 50, as it may cause dizziness or fatigue that can impair your ability to drive or operate machinery.

Betaloc ZOK 50 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 50

This drug should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Tablets of Betaloc ZOK 50 (or their halves) should not be chewed or crushed. The tablets should be swallowed with a drink.
Available are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), and Betaloc ZOK 100 (95 mg).
It is usually recommended to take Betaloc ZOK 50 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 inadequate, your 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. Your 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.
Your doctor may increase the dose to 2 mg/kg body weight, depending on the achieved blood pressure values.
Betaloc ZOK 50 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, your doctor may prescribe Betaloc ZOK 50 in combination with other drugs used to treat angina pectoris.
Symptomatic, chronic heart failure
The dose will be determined by your 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, your doctor will double the dose every two weeks, up to a maximum dose of 200 mg once a day or the maximum tolerated dose.
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, your 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 100-200 mg once a day.
If you feel that the effect of Betaloc ZOK 50 is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Betaloc ZOK 50 than recommended

In case of taking a higher dose of Betaloc ZOK 50 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 50

You should not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 50, and it has been less than 12 hours since the planned time of taking that 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, Betaloc ZOK 50 can cause side effects, although not everybody gets 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,
• 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, 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 occur in less than 1 in 10,000 patients)

• 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,
• psoriasis exacerbation,
• 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 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of this drug.

5. How to store Betaloc ZOK 50

The drug 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 drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not take this drug if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 drug 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 drug 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 what the packaging contains

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 for easier swallowing, not for dividing the tablet into equal doses.
HDPE bottle containing 30 prolonged-release tablets, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, in the country of export:

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

Manufacturer:

Casen Recordati, S.L., Autovía de Logroño, km. 13,300, 50180 Utebo (Saragossa), Spain
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje, Sweden
Savio Industrial S.r.l., Via Emilia, 21, 27100 Pavia, 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
Lithuanian, export country marketing authorization number:LT/1/96/2252/004
Parallel import authorization number:32/18
Date of leaflet approval: 28.10.2022
[Information about the trademark]