Betaloc zok 50

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this 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 this leaflet carefully before taking 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 doubts, consult 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 similar.
• If you experience any adverse effects, including those 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 exertion.
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 insufficient oxygen supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow 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 increase survival, reduce hospitalization rates, improve left ventricular function, and enhance quality of life.

Betaloc ZOK 50 is used in the prevention of:

• recurrent 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,
  • 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) medications 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 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 (your doctor may recommend changing doses of antidiabetic medications),
• 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 your dentist or anaesthesiologist that you are taking Betaloc ZOK 50.
Do not suddenly stop treatment with Betaloc ZOK 50. If stopping treatment is necessary, the medicine should be discontinued gradually, if possible, over a period of at least two weeks, reducing the dose stepwise down to half a 25 mg tablet once daily, for at least four days before completely stopping.

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 medicines available without a prescription, 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 blocking agents (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 50 simultaneously and it becomes necessary to discontinue clonidine, Betaloc ZOK 50 should be discontinued 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 have a baby, 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 potential 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 potential 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 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.
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 patients 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
In 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, not exceeding 50 mg, given 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 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 to treat 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. For patients with more advanced heart failure, your doctor may recommend starting with half a 25 mg tablet once daily for the first week of treatment. The dose will then be doubled by your doctor every two weeks until a maximum dose of 200 mg once daily is reached or until the highest dose tolerated by the patient is achieved.

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 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, 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, ankle swelling, sensation of strong heartbeat, dizziness, fainting, chest pain or tightness, cold skin, weakly palpable 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions that may occur during treatment with this medicine are listed below.
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 they may reduce the dose or gradually discontinue the medicine,
• palpitations,
• changes in blood pressure related to changes in body position (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,
• 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 occur in less than 1 in 1000 patients)

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or eye irritation,
• conjunctivitis,
• conduction disorders in the heart, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, followed by redness of fingers associated with 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 occur in less than 1 in 10,000 patients)
• gangrene (tissue necrosis) in patients with severe peripheral circulatory disorders,
• reduced platelet count, which may lead to easy bruising,
• confusion,
• hallucinations,
• memory loss or memory disturbances,
• taste disturbances,
• tinnitus,
• worsening of intermittent claudication (leg pain while 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 (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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions helps provide more information on the safety of this medicine.

5. How to store Betaloc ZOK 50

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton. 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.
• Each 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, macrogol 6000, titanium dioxide (E171).

What Betaloc ZOK 50 looks like and contents of the pack
HDPE bottle in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, 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
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Marketing Authorization number in Lithuania, country of export: LT/1/96/2252/004
Parallel import license number: 205/22