Betaloc zok 25

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Betaloc ZOK 25 (Betaloc ZOK)
23.75 mg, prolonged-release tablets
Metoprolol succinate
Betaloc ZOK 25 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, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

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-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 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 cardiovascular death (including sudden death),
• 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 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 heart failure medications, to improve 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 following 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. Important 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 beta-adrenergic receptor blocking drugs, e.g. atenolol, propranolol;
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker is 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 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 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 when walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 25 may mask its symptoms,
• phaeochromocytoma,
• psoriasis.

Consult a 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 25.
Do not abruptly stop treatment with Betaloc ZOK 25. If discontinuation of treatment is necessary, the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, reducing the dose down to half of a 25 mg tablet once daily, for at least four days before completely stopping the medicine.

Betaloc ZOK 25 and other medicines
Tell your doctor about all medicines currently used or recently used by the patient, as well as any 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 in 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 25 simultaneously and discontinuation of clonidine treatment is necessary, Betaloc ZOK 25 should be withdrawn several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 25 is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, the 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 have a child, she should consult her doctor before using this medicine.

Pregnancy
Betaloc ZOK 25 should not be used in pregnant women unless the benefits of treatment 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 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
The patient should assess their individual response after taking Betaloc ZOK 25, as dizziness or fatigue may occur in some patients, which may impair psycho-physical performance.

Betaloc ZOK 25 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 25

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 (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 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 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 above 6 years of age, the dose depends on body weight. Your 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 strength closest to the calculated dose.
Your doctor may increase the dose up to 2 mg/kg body weight depending on achieved blood pressure values.
Betaloc ZOK 25 should not be used in children below 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 for 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. For patients with more severe heart failure, your doctor will recommend taking half a 25 mg tablet once daily during the first week of treatment. Afterwards, 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 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, 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, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below is a list of adverse reactions 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 the heart rate; inform your doctor immediately, as the dose of the medicine may need to be reduced or the treatment 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,
• sensation of coldness in hands and feet.

Uncommon (may affect less than 1 in 100 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling or numbness sensation (paraesthesiae),
• worsening of existing heart failure,
• conduction disturbances 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,
• retrosternal pain,
• oedema,
• weight gain.

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

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or irritation of the eyes,
• conjunctivitis,
• conduction disturbances in the heart, 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 abnormalities (detected in blood tests),
• positive antinuclear antibody titre (antibodies used in diagnosing connective tissue diseases).

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

• 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, feeling of fatigue or swelling around the ankles (in case of 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 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 to provide more information on the safety of the medicine.

5. How to store Betaloc ZOK 25

Keep the medicine out of the 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 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 required. This will 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.
• 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 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 can be divided into equal doses.
PVC/Al blisters in a cardboard box.
28 tablets – 2 blisters containing 14 tablets each.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
Recordati Ireland Ltd
Raheens East, Ringaskiddy, Co. Cork, P43 KD30, Ireland
Manufacturer:
Savio Industrial S.r.l.
Via Emilia, 21, 27100 Pavia, Italy
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje, Sweden
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali, 1, 20148 Milan, Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Lithuania, country of export: LT/1/96/2252/002
Parallel import authorisation number: 451/22