Betaloc zok 100

Package leaflet: Information for the patient

NOTE: Keep this leaflet, information on the immediate packaging is in a foreign language.
Betaloc ZOK 100 (Betaloc ZOK), 95 mg, prolonged-release tablets
Metoprololi succinas
Betaloc ZOK 100 and Betaloc ZOK are different trade names for the same medicine.
Please read this 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 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell 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. Important information 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 mental exertion.
This results in a slowing of heart activity (reduction in heart rate).
Betaloc ZOK 100 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 100 is used in preventing:

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

Betaloc ZOK 100 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 100

When not to use Betaloc ZOK 100

• if the patient is allergic to metoprolol tartrate or to 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,
• uncontrolled heart failure (shortness of breath, ankle swelling),
• bradycardia (slowing of the 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, 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 while walking),
• diabetes (your doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 100 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 the dentist or anaesthesiologist that you are taking Betaloc ZOK 100.
Do not abruptly stop treatment with Betaloc ZOK 100. If discontinuation is necessary, the medicine should be gradually withdrawn, if possible, over a period of at least two weeks, reducing the dose gradually down to half a 25 mg tablet once daily, 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 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 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 become pregnant, she should consult her doctor before using this medicine.

Pregnancy
Betaloc ZOK 100 should not be used during pregnancy unless the benefits of treatment outweigh the risks to the fetus. In general, beta-blocking agents, including metoprolol, may cause fetal harm and premature delivery.
If a woman being 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 of treatment 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, which may impair psychomotor performance.

Betaloc ZOK 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 100

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Betaloc ZOK 100 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed whole with liquid.
Betaloc ZOK 100 is usually taken once daily, with or without food.
Your doctor will inform you how and when to take the tablets.
The following strengths are available on the market: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), and Betaloc ZOK 100 (95 mg).

Hypertension
Adults
The recommended dose for patients with mild to moderate hypertension is 50 mg once daily. If the response to the 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 the child's body weight. The doctor will determine the appropriate dose.
The usual initial dose is 1 mg/kg body weight once daily, not exceeding 50 mg, administered as a tablet strength closest to the calculated dose.
Your doctor may increase the dose to 2 mg/kg body weight depending on blood pressure response.
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, your doctor may prescribe Betaloc ZOK 100 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 strength once daily for the first 2 weeks of treatment. For patients with more severe heart failure, your doctor may recommend starting with half a 25 mg tablet once daily for the first week of treatment.
Thereafter, your doctor will double the dose every two weeks until reaching the maximum dose of 200 mg once daily or the highest 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, 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 mg to 200 mg once daily.

If you feel that the effect of Betaloc ZOK 100 is too strong or too weak, consult your doctor or pharmacist.

Taking more Betaloc ZOK 100 than prescribed
If you take more Betaloc ZOK 100 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 100
Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 100 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 listed below may occur during treatment with this medicine.

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 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,
• 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 (paraesthesia),
• 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,
• retrosternal pain,
• oedema (swelling),
• weight gain.

Rare (may occur in less than 1 in 1,000 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, accompanied by 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,
• 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
During treatment with this medicine, the following conditions may worsen:

• shortness of breath, fatigue or swelling around the ankles (in patients with myocardial infarction). These are uncommon adverse reactions, occurring in less than 1 in 100 people.

• psoriasis (a 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 100

Keep the medicine out of the sight and reach of children.
Store below 30 °C, 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. Such measures will help protect the environment.

6. Contents of the pack 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.
• The other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, 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 for easier swallowing only, and not for dividing the tablet into equal doses.
HDPE bottle containing 30 extended-release tablets, in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali 1, 20148 Milan, Italy
Manufacturer:
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje, Sweden
Casen Recordati, S.L., Autovía de Logroño, Km 13,300, 50180 Utebo, Zaragoza, Spain
Parallel importer:
PharmaVitae Sp. z o.o. Sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Authorization number in Romania, country of export: 7136/2014/01
Parallel import authorization number: 136/17