Betaloc zok 50

Package leaflet: Information for the patient

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 medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, 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 medicines used in heart failure, to increase survival, reduce the number of hospitalizations, improve left ventricular function, and improve quality of life.

Betaloc ZOK 50 is used in prevention of:

• recurrence of myocardial infarction or sudden death after 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 any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other beta-adrenergic receptor blocking drugs, e.g. atenolol, propranolol.
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker has been implanted),
• second- or third-degree atrioventricular block,
• decompensated heart failure (shortness of breath, ankle swelling),
• 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 acute 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 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 while 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 refer 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 suddenly stop treatment with Betaloc ZOK 50. If treatment needs to be discontinued, the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, reducing the dose until reaching half a 25 mg tablet once daily, for at least four days before completely stopping administration.

Betaloc ZOK 50 and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes eye drops, injectable medicines, 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 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 medicines (rifampicin), medicines used in peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic receptor blocking medicines (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine together with Betaloc ZOK 50 and treatment with clonidine 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, 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 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
The patient 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 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, Betaloc ZOK 50, and Betaloc ZOK 100.
Betaloc ZOK 50 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed whole 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 of Betaloc ZOK 50 in 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
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 starting dose is 0.5 mg/kg body weight, not exceeding 50 mg, administered once daily 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 under 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 in the treatment of 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 daily for the first 2 weeks of treatment. In 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 a maximum dose of 200 mg once daily or the maximum 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 recurrent 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, 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.

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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The adverse effects 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,
• Slowing of 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,
• Diarrhea,
• Constipation,
• Cold sensation in hands and feet.

Uncommon (may affect less than 1 in 100 patients)

• Depression,
• Insomnia,
• Nightmares,
• Difficulty concentrating,
• Drowsiness,
• Burning, tingling, or numbness sensation (paresthesia),
• Worsening of existing heart failure,
• Heart conduction disturbances, 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,
• Swelling (edema),
• Weight gain.

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

• Nervousness,
• Anxiety states,
• Visual disturbances,
• Dryness and/or eye irritation,
• Conjunctivitis,
• Heart conduction disturbances, 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 titer of antinuclear antibodies (antibodies used in diagnosing connective tissue diseases).

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

• Gangrene (tissue necrosis) in patients with severe peripheral circulatory disorders,
• Decreased platelet count, which may lead to easy bruising,
• Confusion,
• Hallucinations,
• Memory loss or memory disturbances,
• Taste disturbances,
• Tinnitus,
• Worsening of intermittent claudication (leg pain during walking),
• Hepatitis,
• Photophobia (light sensitivity),
• Exacerbation of psoriasis,
• Joint pain.

Conditions that may worsen
The following conditions may worsen during treatment with this medicine:

• Shortness of breath, feeling of fatigue, or swelling around the ankles (in case of myocardial infarction). These are uncommon adverse effects, occurring in less than 1 in 100 people.
• Psoriasis (a skin disease), circulatory disorders. These are rare adverse effects, occurring in less than 1 in 10,000 people.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to collect 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 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. This will help protect the environment.

6. Contents of the packaging 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.
• The other ingredients are: ethylcellulose, hydroxypropylcellulose, hypromellose, microcrystalline cellulose, paraffin, macrogol 6000, colloidal silicon dioxide, sodium stearyl fumarate, 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, bevelled on one side and marked on the other side with "A/mO". The tablet has a score line to facilitate breaking for easier swallowing only, and not for dividing the tablet into equal doses.
HDPE bottle with a cardboard outer containing 30 prolonged-release tablets.
For further detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Romania, 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 (Zaragoza)
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, country of export: 7135/2014/01
Parallel import authorization number: 133/20