Betaloc zok 100

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaloc ZOK 100 (Betaloc ZOK 100 mg), 95 mg, prolonged-release tablets
Metoprololi succinas
Betaloc ZOK 100 and Betaloc ZOK 100 mg are different trade names for the same medicinal product.
Please read the leaflet carefully before using 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Betaloc ZOK 100 is and what it is used for
2. What you need to know before taking Betaloc ZOK 100
3. How to take Betaloc ZOK 100
4. Possible side effects
5. How to store Betaloc ZOK 100
6. Contents of the pack and other information

1. What Betaloc ZOK 100 is and what it is used for

Betaloc ZOK 100 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 activity (reduction in heart rate).
Betaloc ZOK 100 is used in the treatment of:

• high blood pressure (arterial hypertension), to lower blood pressure and reduce the risk of complications (such as myocardial infarction or stroke) and cardiovascular death (including sudden death),
• constricting 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 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 100 is used in prevention of:

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

Betaloc ZOK 100 is used in the treatment of high blood pressure (arterial hypertension) in
children and adolescents aged 6 to 18 years.

2. Important information before using Betaloc ZOK 100

When not to use Betaloc ZOK 100:

• 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 blockers, 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 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) drugs with positive inotropic action stimulating beta-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK 100, consult 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 while walking),
• diabetes (your doctor may need to adjust the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 100 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 100.
Do not suddenly stop treatment with Betaloc ZOK 100. If discontinuation is necessary, the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, reducing the dose stepwise down to half a 25 mg tablet once daily, continued for at least four days before completely stopping.

Betaloc ZOK 100 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, over-the-counter medicines, including herbal medicines 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 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 100 simultaneously, and discontinuation of clonidine treatment becomes necessary, Betaloc ZOK 100 should be discontinued several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 100 is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, your doctor may adjust their dosage.

Betaloc ZOK 100 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 100 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 100 becomes pregnant, she should inform her doctor as soon as possible.

Breastfeeding
Betaloc ZOK 100 should not be used during breastfeeding unless the benefits outweigh the risks to the breastfed infant.

Driving and operating machinery
The patient should assess their individual response after taking Betaloc ZOK 100, as dizziness or fatigue may occur in some patients, impairing psycho-physical performance.

Betaloc ZOK 100 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 100

This medicine should always be used as directed by the physician. In case of doubt, consult a 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 100 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed with liquid.
Betaloc ZOK 100 is usually taken once daily, with or without food. The doctor will inform the patient how and when to take the tablets.

Hypertension
Adults
The recommended dose of Betaloc ZOK 100 in patients with mild to moderate hypertension is 50 mg once daily. If the response to a 50 mg dose is insufficient, the 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. The 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.
The doctor may increase the dose up to 2 mg/kg body weight depending on achieved blood pressure values.
Betaloc ZOK 100 should not be used in children under 6 years of age.

Angina pectoris
The recommended dose is 100–200 mg once daily. If necessary, the doctor may prescribe Betaloc ZOK 100 in combination with other medicines used in the treatment of angina pectoris.

Symptomatic chronic heart failure
The dose will be determined by the doctor. The recommended starting dose is one 25 mg tablet once daily for the first 2 weeks of treatment. For patients with more severe heart failure, the doctor may recommend taking half of a 25 mg tablet once daily during the first week of treatment. The doctor will then double the dose every 2 weeks until reaching the maximum dose of 200 mg once daily or the maximum dose tolerated by the patient.

Cardiac arrhythmias
The recommended dose of Betaloc ZOK 100 is 100–200 mg once daily.

Functional cardiac disorders with palpitations
The recommended dose is 100 mg once daily. If necessary, the 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 the effect of Betaloc ZOK 100 seems too strong or too weak, consult a doctor or pharmacist.

Taking more Betaloc ZOK 100 than prescribed
If more Betaloc ZOK 100 than prescribed has been taken, seek medical advice 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.

Missing a dose of Betaloc ZOK 100
Do not take a double dose to make up for a missed dose.
If a dose of Betaloc ZOK 100 is missed and less than 12 hours have passed since the scheduled time, the missed dose should be taken immediately. If the patient remembers the missed dose after 12 hours or more, the missed dose should be skipped. The next dose should be taken at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in every individual.
The adverse reactions listed below may occur during treatment with this medicine.

Very common (may occur in at least 1 out of 10 patients)

• fatigue.

Common (may occur in less than 1 out of 10 patients)

• dizziness,
• headache,
• slowing of 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 change 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 occur in less than 1 out of 100 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling or numbness sensation (paraesthesiae),
• worsening of existing heart failure,
• disturbances in cardiac conduction, seen 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 occur in less than 1 out of 1,000 patients)

• nervousness,
• anxiety states,
• visual disturbances,
• dryness and/or eye irritation,
• conjunctivitis,
• disturbances in cardiac 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 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 out of 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 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 out of 100 individuals;
• psoriasis (a skin condition), disturbances in blood circulation. These are rare adverse reactions, occurring in less than 1 out of 10,000 individuals.

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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, 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 100

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 packaging and other information

What Betaloc ZOK 100 contains

• The active substance is metoprolol succinate.
• One tablet contains 95 mg of metoprolol succinate, equivalent to 100 mg of metoprolol tartrate.
• Other components of the medicine are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol, titanium dioxide (E 171).

What Betaloc ZOK 100 looks like and contents of the pack
White or almost white, round tablets with a diameter of 10 mm, scored on one side and marked on the other side with "A/mS". The score line is intended to facilitate breaking the tablet solely for easier swallowing, and not for dividing the tablet 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 Croatia, 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, 151 57 Södertälje, Sweden
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali 1, 20148 Milan, Italy
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorization number in Croatia, country of export: HR-H-495596644-01
Parallel import license number: 62/26