Betaloc zok 50

Package leaflet: Information for the patient

Caution! 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 medicinal product.
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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 cardiovascular death (including sudden death),
• 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 ventricular response,
• palpitations (awareness of heartbeat) due to non-organic (functional) heart disorders,
• chronic heart failure (with symptoms such as breathlessness 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 the 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 succinate 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 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 stimulating 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 disorders, or allergic reactions, e.g. to insect venom, food, or other substances. If the patient has ever experienced an asthmatic attack or wheezing, do not use this medicine without consulting a doctor,
• chest pain due to 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 (your doctor may need to adjust 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 your dentist or anaesthesiologist that you are taking Betaloc ZOK 50.
Do not suddenly stop treatment with Betaloc ZOK 50. If treatment must be discontinued, 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, and continuing at this dose for at least four days before completely stopping.

Betaloc ZOK 50 and other medicines
Tell your doctor about all medicines currently used, recently used, or planned for use. 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 the patient is taking any of the following medicines:

• Medicines used to treat cardiovascular diseases (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 blockers (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 50 simultaneously, and clonidine treatment needs to be discontinued, 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, your 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-blocking agents, including metoprolol, may cause fetal harm and premature delivery.
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 treatment outweigh the risks to the breastfed infant.

Driving and operating machinery
Patients should assess their individual response after taking Betaloc ZOK 50, as dizziness or fatigue may occur in some patients, which may 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 prescribed by your 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).
Tablets of Betaloc ZOK 50 (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 adult patients with mild to moderate hypertension is 50 mg once daily. If the response to the 50 mg dose is inadequate, your doctor may increase the dose to 100–200 mg once daily and/or add another antihypertensive medicine.

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

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

Symptomatic chronic heart failure
The dose will be determined by your doctor. The recommended initial dose is one 25 mg tablet once daily for the first 2 weeks of treatment. For patients with more severe heart failure, your doctor may recommend taking half a 25 mg tablet once daily during the first week of treatment. Then, your doctor will double the dose every two weeks until reaching a 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, your doctor may increase the dose to 200 mg once daily.

Prevention of further myocardial infarction or sudden 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, contact your doctor immediately 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, swelling around the ankles, 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 (bluish discoloration of skin).

Missed 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 can cause adverse reactions, although not everyone will experience them.
Below are listed the adverse reactions that may occur during treatment with this medicine.

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

• fatigue.

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

• dizziness,
• headache,
• slowing of the heart rate; inform your doctor immediately, as the doctor may reduce the dose or gradually discontinue the medicine,
• 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 occur in less than 1 in 100 patients)

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

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

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

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

• confusion,
• hallucinations,
• loss of or disturbances in memory,
• taste disturbances,
• tinnitus,
• worsening of intermittent claudication (leg pain during walking),
• hepatitis,
• photosensitivity,
• exacerbation of psoriasis,
• joint pain.

Conditions that may worsen
During treatment with this medicine, the following conditions may worsen:

• shortness of breath, feeling of fatigue or swelling around the ankles (in patients with myocardial infarction). These are uncommon adverse reactions occurring in less than 1 in 100 people.
• psoriasis (skin disease), 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 adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betaloc ZOK 50

Keep this medicine out of the 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 stated 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. Such measures help protect the environment.

6. Contents of the pack 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, macrogol, 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 breaking the tablet solely for easier swallowing and is not intended for dividing the tablet into equal doses.
Packaged in a high-density polyethylene (HDPE) bottle with a polypropylene cap, containing 30 tablets, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization 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 (Zaragoza), Spain
AstraZeneca AB, Gärtunavägen, SE-152 57 Södertälje, Sweden
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorization Number in Latvia, country of export: 98-0300
Parallel Import License Number: 156/25