Betaloc zok 25

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Betaloc ZOK 25
23.75 mg, prolonged-release tablets
Metoprololi succinas
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, please 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Betaloc ZOK 25 is and what it is used for
2. Important information before taking Betaloc ZOK 25
3. How to take Betaloc ZOK 25
4. Possible side effects
5. How to store Betaloc ZOK 25
6. Contents of the package and other information

1. What Betaloc ZOK 25 is and what it is used for

Betaloc ZOK 25 contains the active substance metoprolol, which belongs to a group of medicines called
beta-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 25 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 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 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 medicines used in heart failure, to increase survival, reduce hospitalization rates, improve left ventricular function, and enhance quality of life.

Betaloc ZOK 25 is used in prevention of:

• recurrence of myocardial infarction or sudden death after the acute phase of myocardial infarction,
• migraine attacks.

Betaloc ZOK 25 is used in the treatment of high blood pressure (hypertension) in
children and adolescents aged 6 to 18 years.

2. Information before using Betaloc ZOK 25

When not to use Betaloc ZOK 25

• 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 β-adrenergic 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 β-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK 25, 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 (your doctor may recommend adjusting the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 25 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 25.
Do not stop treatment with Betaloc ZOK 25 abruptly. If discontinuation is necessary, 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, continued for at least four days before completely stopping the medicine.

Betaloc ZOK 25 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 medicines (rifampicin), medicines used in peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other β-adrenergic blocking agents (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 25 simultaneously, and discontinuation of clonidine treatment becomes necessary, Betaloc ZOK 25 should be withdrawn several days before stopping clonidine. Information on discontinuing Betaloc ZOK 25 can be found in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, your doctor may adjust their dosage.

Betaloc ZOK 25 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 25 should not be used during pregnancy unless the benefits of treatment outweigh the risks to the fetus. In general, β-adrenolytic agents, including metoprolol, may cause fetal harm and premature delivery.
If a woman treated with Betaloc ZOK 25 becomes pregnant, she should inform her doctor as soon as possible.

Breastfeeding
Betaloc ZOK 25 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 to Betaloc ZOK 25, as dizziness or fatigue may occur in some patients, which could impair psychomotor performance.

Betaloc ZOK 25 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Betaloc ZOK 25

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Available on the market are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), and Betaloc ZOK 100 (95 mg).
Betaloc ZOK 25 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed whole with liquid.
Betaloc ZOK 25 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
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, not exceeding 50 mg, administered once daily 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 25 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 25 in combination with other medicines used to treat angina pectoris.

Symptomatic chronic heart failure
Your doctor will determine the dose. The recommended initial dose is 1 tablet of 25 mg 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. Thereafter, 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 25 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 100–200 mg once daily.

If you feel that the effect of Betaloc ZOK 25 is too strong or too weak, consult your doctor or pharmacist.

Taking more Betaloc ZOK 25 than prescribed
If you take more Betaloc ZOK 25 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 25
Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 25 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 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, seen on ECG (first-degree heart block),
• Sudden drop in blood pressure during heart attack (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 fingers with associated numbness and pain (Raynaud's phenomenon),
• Nasal mucosal inflammation,
• Dryness of the oral mucosa,
• Hair loss,
• Erectile dysfunction (impotence),
• Liver function abnormalities (detected in blood tests),
• Positive antinuclear antibody titer (antibodies used in diagnosing connective tissue diseases).

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

• Tissue necrosis (gangrene) 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,
• Photophobia (light sensitivity),
• Exacerbation of psoriasis,
• Joint pain.

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

• Shortness of breath, fatigue, or swelling around the ankles (in patients after myocardial infarction). These are uncommon adverse effects, occurring in less than 1 in 100 people.
• Psoriasis (a skin condition), 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 provide more information on the safety of the medicine.

5. How to store Betaloc ZOK 25

Keep this medicine out of sight and reach of children.
Store below 30℃.
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. These measures help protect the environment.

6. Contents of the pack and other information

What Betaloc ZOK 25 contains

• The active substance is metoprolol succinate.
• One tablet contains 23.75 mg of metoprolol succinate, equivalent to 25 mg of metoprolol tartrate.
• Other components are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide.

What Betaloc ZOK 25 looks like and contents of the pack
White or almost white, oval tablets measuring 5.5 mm x 10.5 mm, with notches on both sides,
marked "A/β" on one side. The tablet may be divided into equal doses.
PVC/PVDC/Al blisters in a cardboard box. Blisters with days of the week markings.
28 tablets – 2 blisters containing 14 tablets each.
For further information, please contact the responsible party or the parallel importer.
Responsible party in the Czech Republic, country of export:
Herbacos Recordati s.r.o.
generála Svobody 335
Rosice, 533 51 Pardubice
Czech Republic
Manufacturer:
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia
Italy
Casen Recordati, S.L.
Autovía de Logroño, km.13,300
50180 Utebo (Zaragoza)
Spain
AstraZeneca AB
Södertälje
Sweden
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milan
Italy
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 authorisation number in the Czech Republic, country of export: 58/117/01-C
Parallel import authorisation number: 146/21
Translation of the symbols for days of the week printed next to each tablet in the immediate packaging:
Po – Monday
Út – Tuesday
St – Wednesday
Čt – Thursday
Pá – Friday
So – Saturday
Ne – Sunday