Betaloc zok 50

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Betaloc ZOK 50 (Betaloc ZOK)
47.5 mg, prolonged-release tablets
Metoprololi succinas
Betaloc ZOK 50 and Betaloc ZOK are different trade names for the same medicine.
Please read the entire leaflet carefully before using this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 slower heart function (reduced 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 inadequate 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 increase 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 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 agents, 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,
• uncontrolled 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 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. You should
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 asthma attack or wheezing – this medicine should not be used 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 while walking),
• diabetes (your 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 suddenly stop treatment with Betaloc ZOK 50. If discontinuation of treatment is necessary,
the medicine should be withdrawn gradually, if possible, over a period of at least two weeks,
with decreasing doses down to 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 currently used or recently used by the patient, as
well as 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 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 discontinuation of clonidine treatment becomes necessary, Betaloc ZOK 50 should be withdrawn a few days before stopping clonidine. Information on discontinuation of Betaloc ZOK 50 can be found 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 outweigh the risks to the fetus. In general, beta-adrenolytic 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
The patient should assess their individual response after taking Betaloc ZOK 50, as some patients may experience dizziness or fatigue which may impair psycho-motor performance.

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

3. How to use Betaloc ZOK 50

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following are available in the market: 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 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 for adults 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 the child's body weight. Your
doctor will determine the appropriate dose.
The usual initial dose is 0.5 mg/kg body weight once daily, not exceeding 50 mg, administered as a
tablet with strength closest to the calculated dose.
Your 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, 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 starting dose is one 25 mg tablet
once daily for the first 2 weeks of treatment. For patients with more advanced heart failure, your
doctor may recommend starting with half a 25 mg tablet once daily for the first week. Then, your
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 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
emergency department of your nearest hospital.
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.

If you forget to take Betaloc ZOK 50
Do not take a double dose to make up for a missed dose.
If you forget to take 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 everyone will experience them.
Below is a list of adverse effects that may occur during treatment with this medicine.

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

• fatigue.

Common (may affect less than 1 in 10 people)

• dizziness,
• headache,
• slowed heart rate; inform your doctor immediately, as they 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 affect less than 1 in 100 people)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling or numbness sensation (paraesthesiae),
• worsening of existing heart failure,
• disturbances in heart conduction, detected on ECG (first-degree heart 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 people)

• nervousness,

• anxiety states,

• visual disturbances,

• dryness and/or irritation of the eyes,

• conjunctivitis,

• disturbances in heart conduction, cardiac arrhythmias, worsening of existing atrioventricular block,

• pallor, cyanosis, followed by redness of fingers with associated numbness and pain (Raynaud's phenomenon),

• nasal mucosal inflammation,

• dryness of the oral mucosa,

• hair loss,

• erectile dysfunction (impotence),

• liver function disorders (detected in blood tests),

• positive antinuclear antibody titre (antibodies used in diagnosis of connective tissue diseases).

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

• gangrene (tissue necrosis) in patients with severe peripheral circulatory 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 cases of myocardial infarction). These are uncommon adverse effects, occurring in less than 1 in 100 people.
• psoriasis (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, pharmacist or nurse. Adverse effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible party or parallel importer.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Betaloc ZOK 50

Keep the medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
Keep 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• Other components are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, polyethylene glycol 6000, titanium dioxide.

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 only to facilitate swallowing by allowing the tablet to be broken, but it is not intended for dividing the tablet into equal doses.
HDPE bottle in a cardboard box.
30 prolonged-release tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, the 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 (Zaragoza)
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 in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation Number in Lithuania, the country of export: LT/1/96/2252/004
Parallel Import Authorisation Number: 170/24