Betaloc zok 50

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is 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 medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Betaloc ZOK 50 is and what it is 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 pack and other information

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

Betaloc ZOK 50 contains the active substance metoprolol, which belongs to a group of medicines called beta-blockers.
Metoprolol reduces the effects of stress hormones on the heart during physical and psychological stress. This results in a slowing of heart function (reduction in 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 myocardial infarction or stroke) and death (including sudden cardiac death) due to cardiovascular causes,
• chest pain caused by insufficient oxygen supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow down ventricular rate,
• palpitations (awareness of heartbeat) due to non-organic (functional) heart disorders,
• chronic heart failure (with symptoms such as shortness of breath and ankle swelling), in combination with other heart failure medications, to improve survival, reduce hospitalization rates, improve left ventricular function, and enhance quality of life.

Betaloc ZOK 50 is used in prevention of:

• recurrence of myocardial infarction or sudden death following the acute phase of myocardial infarction,
• migraine attacks.

Betaloc ZOK 50 is used in the treatment of 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other beta-adrenergic receptor-blocking drugs, such as atenolol or propranolol;
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a cardiac pacemaker has been implanted),
• second- or third-degree atrioventricular block,
• decompensated heart failure (shortness of breath, swelling around the ankles),
• bradycardia (slowed heart rate below 45 beats per minute),
• very low blood pressure which may cause fainting,
• severe peripheral arterial circulatory disorders,
• metabolic acidosis,
• untreated phaeochromocytoma,
• suspected recent myocardial infarction, if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 s, or systolic blood pressure is less than 100 mmHg.
• if the patient is receiving (short- or long-term) drugs with positive inotropic action that stimulate beta-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK 50, discuss this with your doctor. Inform your doctor if the patient has:

• bronchial asthma, wheezing or other similar breathing problems, or allergic reactions, e.g. to insect venom, food, or other substances. If the patient has ever had an asthma attack or wheezing, do not use this medicine without consulting a doctor,
• chest pain caused by Prinzmetal's angina,
• circulatory disorders or heart failure,
• liver disease,
• first-degree heart block (conduction disturbances in the heart),
• intermittent claudication (tiring and weakening of one or both legs during walking),
• diabetes (the doctor may recommend adjusting the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 50 may mask its symptoms,
• phaeochromocytoma,
• psoriasis.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Before planned anaesthesia, inform the dentist or anaesthesiologist that the patient is taking Betaloc ZOK 50.
Do not abruptly stop treatment with Betaloc ZOK 50. If discontinuation is necessary, the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, reducing the dose stepwise down to half a 25 mg tablet once daily, maintained for at least four days before complete cessation.

Betaloc ZOK 50 and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use. This includes eye drops, injectable medicines, and over-the-counter medicines, including herbal remedies and dietary supplements. Some medicines may affect the action of other medicines. Consult your doctor if the patient is taking any of the following medicines:

• Medicines used to treat cardiovascular disorders (such as digitalis glycosides/digoxin, calcium antagonists, antiarrhythmics, ganglion-blocking agents, hydralazine).
• Other medicines such as monoamine oxidase inhibitors (MAO inhibitors), inhaled anaesthetics, antibacterial agents (rifampicin), medicines used for peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic receptor-blocking agents (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine together with Betaloc ZOK 50 and discontinuation of clonidine is necessary, Betaloc ZOK 50 should be withdrawn several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 50 is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, the doctor may adjust 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Pregnancy
Betaloc ZOK 50 should not be used during pregnancy unless the benefits of treatment outweigh the risks to the fetus. In general, beta-adrenolytic medicines, including metoprolol, may cause fetal harm and premature labour.
If a woman being treated with Betaloc ZOK 50 becomes pregnant, she should inform her doctor immediately.

Breastfeeding
Betaloc ZOK 50 should not be used during breastfeeding unless the benefits of treatment outweigh the risks to the breastfed infant.

Driving and using machines
The patient should assess their individual response after taking Betaloc ZOK 50, as dizziness or fatigue may occur in some patients, which could impair psychomotor performance.

Betaloc ZOK 50 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Betaloc ZOK 50

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Available on the market are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc
ZOK 100 (95 mg).
Betaloc ZOK 50 tablets (or their halves) must not be chewed or crushed. Tablets (or their
halves) should be swallowed with liquid.
Betaloc ZOK 50 is usually taken once daily, with or without food. Your doctor will inform you
how and when to take the tablets.

Hypertension
Adults
The recommended dose for patients with mild to moderate hypertension is 50 mg once daily. If
the response to the 50 mg dose is insufficient, the doctor may increase it to 100–200 mg once daily
and/or add another antihypertensive medicine.

Children and adolescents
For children and adolescents over 6 years of age, the dose depends on body weight. The doctor will
determine the appropriate dose.
The usual starting dose is 0.5 mg/kg body weight, not exceeding 50 mg, administered once daily as
a tablet with strength closest to the calculated dose.
The doctor may increase the dose up to 2 mg/kg body weight depending on blood pressure response.
Betaloc ZOK 50 should not be used in children under 6 years of age.

Angina pectoris
The recommended dose is 100–200 mg once daily. If necessary, the doctor may prescribe Betaloc
ZOK 50 in combination with other medicines used in the treatment of angina pectoris.

Symptomatic, chronic heart failure
The dose will be determined by the doctor. The recommended starting dose is 1 tablet of 25 mg
once daily for the first 2 weeks of treatment. For patients with more advanced heart failure, the
doctor may recommend taking half a 25 mg tablet once daily during the first week of treatment.
Thereafter, the doctor will double the dose every two weeks until reaching the maximum dose of
200 mg once daily or the highest dose tolerated by the patient.

Cardiac arrhythmias
The recommended dose of Betaloc ZOK 50 is 100–200 mg once daily.

Functional cardiac 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 recurrent myocardial infarction or sudden cardiac death after the acute phase of
myocardial infarction
The recommended dose is 200 mg once daily.

Migraine prophylaxis
The recommended dose is 100 mg to 200 mg once daily.

If you feel that the effect of Betaloc ZOK 50 is too strong or too weak, consult your doctor or
pharmacist.

Taking more Betaloc ZOK 50 than prescribed
If you take more Betaloc ZOK 50 than prescribed, seek immediate medical advice from your doctor
or go to the nearest hospital emergency department.
In case of significant overdose, the following symptoms may occur: slow or irregular heartbeat,
shortness of breath, ankle swelling, sensation of strong heartbeat, dizziness, fainting, chest pain or
tightness, 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
Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 50 and less than 12 hours have passed since the scheduled time,
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 adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below may occur during treatment with this medicine.

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

• fatigue.

Common (may affect less than 1 in 10 patients)

• dizziness,
• headache,
• slowed heart rate; inform your doctor immediately, as the dose of the medicine may need to be reduced or the treatment gradually discontinued,
• palpitations,
• changes in blood pressure related to change in body position (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhoea,
• constipation,
• cold sensation in hands and feet.

Uncommon (may affect less than 1 in 100 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• tingling, numbness or burning sensations (paraesthesiae),
• worsening of existing heart failure,
• conduction disorders in the heart, detected on ECG (first-degree atrioventricular block),
• sudden drop in blood pressure during myocardial infarction (cardiogenic shock),
• bronchospasm,
• vomiting,
• skin rash,
• excessive sweating,
• muscle cramps,
• chest pain,
• oedema,
• weight gain.

Rare (may affect less than 1 in 1,000 patients)

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or irritation of the eyes,
• conjunctivitis,
• conduction disorders in the heart, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, followed by redness of fingers, accompanied by numbness and pain (Raynaud's phenomenon),
• nasal mucosal irritation,
• dryness of the oral mucosa,
• hair loss,
• erectile dysfunction (impotence),
• liver function disorders (detected in blood tests),
• positive antinuclear antibody titre (antibodies used in diagnosing connective tissue diseases).

Very rare (may affect less than 1 in 10,000 patients)

• tissue necrosis in patients with severe peripheral vascular disorders,
• reduced platelet count, which may lead to easy bruising,
• confusion,
• hallucinations,
• loss or disturbances of memory,
• taste disturbances,
• 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 during treatment with this medicine:

• shortness of breath, fatigue or swelling around the ankles (in patients after myocardial infarction). These are uncommon adverse reactions, occurring in less than 1 in 100 people;
• psoriasis (a skin disorder), circulatory disorders. These are rare adverse reactions, occurring in less than 1 in 10,000 people.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betaloc ZOK 50

Keep the medicine out of sight and reach of children.
Store below 30°C.
Keep the tablets 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 specified month.
Do not take this medicine if the packaging is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Betaloc ZOK 50 contains

• The active substance is metoprolol succinate. One tablet contains 47.5 mg of metoprolol succinate, equivalent to 50 mg of metoprolol tartrate.
• Other components of the medicine are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, polyethylene glycol, 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 score line on one side and marked on the other side with "A/mO". The score line is intended to facilitate tablet breaking for easier swallowing only, and is not intended for dividing the tablet into equal doses.
The container is a high-density polyethylene (HDPE) bottle with a polypropylene cap, placed in a cardboard box.
The pack contains 30 prolonged-release tablets.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Latvia, 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-152 57 Södertälje
Sweden
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 Authorisation Number in Latvia, country of export: 98-0300
Parallel Import Authorisation Number: 178/24