Betaloc zok 50

Patient Information Leaflet

Caution! Keep this leaflet! Information on the immediate packaging is 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 brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• 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 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

1. What Betaloc ZOK 50 is and what it is used for
2. What you need to know 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 β-adrenolytics.
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 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 breathlessness and ankle swelling), in combination with other medicines used in heart failure, 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 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 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 asthma 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 being treated with 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 until reaching half a 25 mg tablet once daily, for at least four days before completely stopping intake.

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, 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 in 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 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 its effects.

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-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 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, impairing psychophysical 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 your doctor. If in doubt, consult your doctor or pharmacist.
Betaloc ZOK 50 tablets (or their halves) must not be chewed or crushed. Tablets should be swallowed whole with liquid.
Available in the market are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), and Betaloc ZOK 100 (95 mg).
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 a 50 mg dose is insufficient, 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 over 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, 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 must 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 initial 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. Thereafter, 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 subsequent 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 100–200 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 rapid 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 everyone will experience them.
The adverse effects listed below 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,
• slowing of the heart rate; inform your doctor immediately, as the dose may need to be reduced or the medicine gradually discontinued,
• palpitations,
• changes in blood pressure related to changes 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 sensations (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,
• 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 cardiac conduction, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, followed by redness of the fingers, accompanied by numbness and pain (Raynaud's phenomenon),
• nasal mucosal irritation,
• dryness of the oral mucosa,
• hair loss,
• erectile dysfunction (impotence),
• liver function abnormalities (detected in blood tests),
• positive antinuclear antibody test (antibodies used in diagnosing 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,
• disturbances in taste,
• 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, feeling of 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 (a skin condition), circulatory disturbances. 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, 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 provide 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.
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 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 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.
• The other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, 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, scored on one side and marked on the other side with “A/mO”. The score line is intended only to facilitate swallowing and not to divide the tablet into equal doses.
HDPE bottle containing 30 prolonged-release tablets, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Recordati Ireland Ltd, Raheens East, Ringaskiddy, Co. Cork, P43 KD30, Ireland
Manufacturers:
Casen Recordati, S.L., Autovía de Logroño, km. 13,300, 50180 Utebo (Saragossa), Spain
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje, Sweden
Savio Industrial S.r.l., Via Emilia, 21, 27100 Pavia, Italy
Parallel Importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Relabeled at:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/96/2252/004
Parallel Import Authorisation Number: 32/18