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 medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Betaloc ZOK 100 and what is it used for
• 2. Important information before taking Betaloc ZOK 100
• 3. How to take Betaloc ZOK 100
• 4. Possible side effects
• 5. How to store Betaloc ZOK 100
• 6. Contents of the packaging and other information

1. What is Betaloc ZOK 100 and what is it used for

Betaloc ZOK 100 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 (reduced heart rate).
Betaloc ZOK 100 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,
• 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 100 is used in the prevention of:

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

Betaloc ZOK 100 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 100

When not to take Betaloc ZOK 100

• 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-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 circulatory 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) inotropic agents with positive beta-adrenergic receptor activity.

Warnings and precautions

Before starting treatment with Betaloc ZOK 100, discuss it with your doctor. 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, do not take this medicine 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 (leg fatigue or weakness when walking),
• diabetes (your doctor may recommend changing the dose of your diabetes medication),
• hyperthyroidism - Betaloc ZOK 100 may mask its symptoms,
• pheochromocytoma,
• psoriasis.

Consult your doctor, even if the above warnings apply to past situations.
Before planned anesthesia, inform your dentist or anesthesiologist that you are taking Betaloc ZOK 100.
Do not stop taking Betaloc ZOK 100 abruptly. 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 once a day, for at least four days before completely stopping the medicine.

Betaloc ZOK 100 with other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any medicines you plan 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. Consult your doctor if you are taking any of the following medicines:

• Medicines used to treat cardiovascular diseases (such as digitalis glycosides, calcium antagonists, anti-arrhythmic agents, anti-adrenergic 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 antidepressants and antipsychotics, antihistamines, other beta-blockers (e.g., eye drops), and other substances (e.g., alcohol, certain hormones),
• If you are taking clonidine and Betaloc ZOK 100, and it is necessary to stop clonidine treatment, Betaloc ZOK 100 should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 100 can be found in the "Warnings and precautions" section.
• If you are taking oral diabetes medications, your doctor may change their dosage.

Betaloc ZOK 100 with food, drink, or alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
Betaloc ZOK 100 should not be taken during pregnancy, 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 you become pregnant while taking Betaloc ZOK 100, inform your doctor as soon as possible.
Breastfeeding
Betaloc ZOK 100 should not be taken during breastfeeding, unless the benefits of its use outweigh the risks to the breastfed child.

Driving and using machines

Check your individual reaction to Betaloc ZOK 100, as it may cause dizziness or fatigue that can affect your ability to drive or operate machinery.

Betaloc ZOK 100 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 100

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Available are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).
Do not chew or crush Betaloc ZOK 100 tablets (or their halves). Swallow the tablets (or their halves) with a liquid.
It is usually recommended to take Betaloc ZOK 100 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 Betaloc ZOK 100 is 50 mg once a day for patients with mild to moderate hypertension. If the response to the 50 mg dose is inadequate, the doctor may increase it to 100-200 mg once a day and (or) add another blood pressure-lowering 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.
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 100 should not be taken in children under 6 years old.
Angina pectoris
The recommended dose of Betaloc ZOK 100 is 100-200 mg once a day. If necessary, the doctor may prescribe Betaloc ZOK 100 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 100 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
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 100 is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Betaloc ZOK 100 than recommended

If you have taken a higher dose of Betaloc ZOK 100 than recommended, consult your doctor or go to the emergency department of the nearest hospital 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, chest pain or pressure, 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 100

Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 100, and it has been less than 12 hours since the planned time of taking that dose, take the missed dose immediately. If you remember the missed dose after 12 hours or more, skip the missed dose. Take the next dose at the usual time.

4. Possible side effects

Like all medicines, Betaloc ZOK 100 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; inform your doctor immediately, as they may reduce the dose or gradually stop the medicine,
• 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,
• tingling, numbness, or burning sensation (paresthesia),
• worsening of existing heart failure,
• conduction disorders in the heart, detected in the ECG (first-degree atrioventricular block),
• severe 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,

• paleness, cyanosis, followed by redness of the fingers with accompanying numbness and pain (Raynaud's syndrome),
• rhinitis,
• dryness of the mucous membranes 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 circulatory 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 you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Betaloc ZOK 100

Keep the medicine out of the 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.
Do not take this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. 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 100 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.

What Betaloc ZOK 100 looks like and contents of the pack

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 designed to facilitate breaking the tablet, solely to make it easier to swallow, and not to divide the tablet into equal doses.
HDPE bottle in a cardboard box.
30 prolonged-release tablets.
For more detailed information, consult 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:

AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 Utebo (Saragossa)
Spain
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
I-20148 Milan
Italy
Savio Industrial S.r.L.
Via Emilia, 21
27100 Pavia
Italy

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Marketing authorization number in Lithuania, country of export:LT/1/96/2252/006

Parallel import authorization number: 171/24

Date of approval of the leaflet: 24.04.2024

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