Betaloc Zok 100

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Betaloc ZOK 100(Betaloc ZOK)

95 mg, prolonged-release tablets

Metoprolol succinate
Betaloc ZOK 100 and Betaloc ZOK are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, 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 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Betaloc ZOK 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 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 is used in the prevention of:

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

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

2. Important information before taking Betaloc ZOK

When not to take Betaloc ZOK

• 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 below 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 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,
• 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, the patient should discuss it with their doctor. The patient should inform their doctor if they have:

• 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 their 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 pain or cramping during walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic medications),
• hyperthyroidism - Betaloc ZOK may mask its symptoms,
• pheochromocytoma,
• psoriasis.

The patient should consult their doctor, even if the above warnings apply to past situations.
Before planned anesthesia, the patient should inform their dentist or anesthesiologist about taking Betaloc ZOK.
The patient should not suddenly stop taking Betaloc ZOK. If it is necessary to stop treatment, the medicine 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 medicine.

Betaloc ZOK and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes eye drops, injectable medicines, over-the-counter medicines, herbal medicines, and dietary supplements. Some medicines may affect the action of other medicines. The patient should consult their doctor if they are taking any of the following medicines:

• Medicines used to treat cardiovascular diseases (such as digitalis glycosides/digoxin, calcium antagonists, antiarrhythmic agents, antiadrenergic agents, hydralazine),
• Other medicines, such as monoamine oxidase inhibitors (MAOIs), inhaled anesthetics, antibiotics (rifampicin), medicines used to treat stomach ulcers (cimetidine), anti-inflammatory medicines (e.g., indomethacin, celecoxib), certain antidepressant and antipsychotic medicines, 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 and it is necessary to stop clonidine treatment, Betaloc ZOK should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 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 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 they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Betaloc ZOK should not be used in pregnant women unless the benefits of its use outweigh the risks to the fetus. In general, beta-adrenergic blockers, including metoprolol, may cause fetal harm and premature birth.
If a woman taking Betaloc ZOK becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK should not be used 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, as it may cause dizziness or fatigue that impairs psychophysical performance.

Betaloc ZOK 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

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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.
The tablets of Betaloc ZOK (or their halves) should not be chewed or crushed. The tablets (or their halves) should be swallowed with a liquid.
It is usually recommended to take Betaloc ZOK 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 Betaloc ZOK for patients with mild to moderate hypertension is 50 mg once daily. If the response to the 50 mg dose is inadequate, the doctor may increase it to 100-200 mg once daily and (or) add another antihypertensive medicine.
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.
The usual initial dose is 0.5 mg/kg body weight, not more than 50 mg, given once daily 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 should not be used in children under 6 years of age.
Angina pectoris
The recommended dose of Betaloc ZOK is 100-200 mg once daily. If necessary, the doctor may prescribe Betaloc ZOK 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 daily for the first 2 weeks of treatment. Patients with more severe heart failure may be advised by their doctor to take half a 25 mg tablet once daily 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 daily or the maximum tolerated dose by the patient.
Arrhythmias
The recommended dose of Betaloc ZOK is 100-200 mg once daily.
Functional heart disorders with palpitations
The recommended dose is 100 mg once daily. If necessary, the doctor may increase the dose to 200 mg once daily.
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 daily.
Migraine prophylaxis
The recommended dose is 100-200 mg once daily.
If the patient feels that the effect of Betaloc ZOK is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Betaloc ZOK than recommended

In case of taking a higher dose of Betaloc ZOK than recommended, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital.
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, 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

The patient should not take a double dose to make up for a missed dose.
If the patient misses a dose of Betaloc ZOK and it has been less than 12 hours since the planned time of taking the dose, they should take the missed dose immediately. If the patient remembers the missed dose more than 12 hours later, they should skip the missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all medicines, Betaloc ZOK 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 patient should immediately inform their doctor, as they may reduce the dose of the medicine or gradually stop taking 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 ECG (first-degree atrioventricular block),
• severe drop in blood pressure during 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, and subsequent rubor 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 antibodies (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 during 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Betaloc ZOK

The medicine should be stored in a place that is out of sight and reach of children.
Store in a temperature below 30°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 month stated.
Do not take this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 contains

• The active substance of the medicine is metoprolol succinate.
• One tablet contains 95 mg of metoprolol succinate, which corresponds to 100 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 looks like and what the packaging contains

Betaloc ZOK 100
White or almost white, round tablets with a diameter of 10 mm, with a notch on one side, marked with "A/mS" on the other side. The notch line is intended to facilitate breaking the tablet, solely to make it easier to swallow, and not to divide the tablet into equal doses.
A HDPE bottle in a cardboard box containing 30 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milan
Italy

Manufacturer:

AstraZeneca AB
Gärtunavägen
SE - 151 85 Södertälje
Sweden
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 Utebo, Saragossa
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 7136/2014/01

Parallel import authorization number: 301/22 Date of approval of the leaflet: 03.08.2022

[Information about the trademark]